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| Name | Class |
|---|---|
| Otto Bock Healthcare Products GmbH | INDUSTRY |
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The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with C-brace | Experimental | C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Brace | Device | C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis | During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body). | week 5 |
| Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis | During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body). | week 9 |
| Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG) | Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body). | week 5 |
| Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG) |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Timed Up and Go Test | Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity. | week 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Francisco, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TIRR Research Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | With C-brace | C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported for the 15 participants who received the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | With C-brace | C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis | During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body). | Posted | Mean | Standard Deviation | degrees | week 5 |
|
23 months
2 withdrew before adverse event data was collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | With C-brace | C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall at home/office | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Francisco, MD | The University of Texas Health Science Center at Houston | 713-797-7636 | Gerard.E.Francisco@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2017 | Nov 7, 2020 | Prot_SAP_000.pdf |
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Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body). |
| week 9 |
| Metabolic Expenditure During Walking | Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally. | week 5 |
| Metabolic Expenditure During Walking | Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally. | week 9 |
| Score on the Timed Up and Go Test | Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity. | week 5 |
| Score on the Timed Up and Go Test | Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity. | week 9 |
| Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE) | Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome. | week 0 |
| Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE) | Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome. | week 9 |
| Change in Hip Flexors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors. | week 0, week 9 |
| Change in Hip Extensors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors. | week 0, week 9 |
| Change in Hip Abductors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors. | week 0, week 9 |
| Change in Hip Adductors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors. | week 0, week 9 |
| Change in Knee Flexors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors. | week 0, week 9 |
| Change in Knee Extensors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors. | week 0, week 9 |
| Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors. | week 0, week 9 |
| Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors. | week 0, week 9 |
| Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured [it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)]. | week 0 |
| Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured [it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)]. | week 9 |
| Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured [it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)]. | week 0 |
| Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured [it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)]. | week 9 |
| Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured [it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)]. | week 0 |
| Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured [it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)]. | week 9 |
| Motor Impairment as Determined by the Fugl-Meyer Assessment | The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment. | week 0 |
| Motor Impairment as Determined by the Fugl-Meyer Assessment | The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment. | week 9 |
| Spasticity as Assessed by the Modified Ashworth Scale (MAS) | This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs. | week 0 |
| Spasticity as Assessed by the Modified Ashworth Scale (MAS) | This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs. | week 9 |
| Static Balance as Assessed by the Berg Balance Scale (BBS) | A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability. | week 0 |
| Static Balance as Assessed by the Berg Balance Scale (BBS) | A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability. | week 9 |
| Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk. | week 0 |
| Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk. | week 5 |
| Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk. | week 9 |
| Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)]. | week 0 |
| Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)]. | week 5 |
| Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)]. | week 9 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis | During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body). | Posted | Mean | Standard Deviation | degrees | week 9 |
|
|
|
| Primary | Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG) | Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body). | Posted | Mean | Standard Deviation | volts | week 5 |
|
|
|
| Primary | Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG) | Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body). | Posted | Mean | Standard Deviation | volts | week 9 |
|
|
|
| Primary | Metabolic Expenditure During Walking | Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally. | Data were not collected for 2 participants. | Posted | Mean | Standard Deviation | millilters/kilogram/minute (mL/kg/min) | week 5 |
|
|
|
| Primary | Metabolic Expenditure During Walking | Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally. | Data were not collected for 2 participants. | Posted | Mean | Standard Deviation | millilters/kilogram/minute (mL/kg/min | week 9 |
|
|
|
| Secondary | Score on the Timed Up and Go Test | Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity. | Data were not collected for 3 participants. | Posted | Mean | Standard Deviation | seconds | week 0 |
|
|
|
| Secondary | Score on the Timed Up and Go Test | Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity. | Posted | Mean | Standard Deviation | seconds | week 5 |
|
|
|
| Secondary | Score on the Timed Up and Go Test | Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity. | Posted | Mean | Standard Deviation | seconds | week 9 |
|
|
|
| Secondary | Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE) | Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | week 0 |
|
|
|
| Secondary | Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE) | Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | week 9 |
|
|
|
| Secondary | Change in Hip Flexors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Hip Extensors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Hip Abductors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Hip Adductors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Knee Flexors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Knee Extensors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry | Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors. | Data for this outcome measure were not collected for any participant. | Posted | week 0, week 9 |
|
|
| Secondary | Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured [it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)]. | Posted | Count of Participants | Participants | week 0 |
|
|
|
| Secondary | Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured [it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)]. | Posted | Count of Participants | Participants | week 9 |
|
|
|
| Secondary | Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured [it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)]. | Posted | Count of Participants | Participants | week 0 |
|
|
|
| Secondary | Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured [it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)]. | Posted | Count of Participants | Participants | week 9 |
|
|
|
| Secondary | Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured [it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)]. | Posted | Count of Participants | Participants | week 0 |
|
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| Secondary | Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry | Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured [it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)]. | Posted | Count of Participants | Participants | week 9 |
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| Secondary | Motor Impairment as Determined by the Fugl-Meyer Assessment | The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment. | Posted | Mean | Standard Deviation | score on a scale | week 0 |
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| Secondary | Motor Impairment as Determined by the Fugl-Meyer Assessment | The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment. | Posted | Mean | Standard Deviation | score on a scale | week 9 |
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| Secondary | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs. | Posted | Mean | Standard Deviation | score on a scale | week 0 |
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| Secondary | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs. | Posted | Mean | Standard Deviation | score on a scale | week 9 |
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| Secondary | Static Balance as Assessed by the Berg Balance Scale (BBS) | A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability. | Posted | Mean | Standard Deviation | score on a scale | week 0 |
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| Secondary | Static Balance as Assessed by the Berg Balance Scale (BBS) | A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability. | Posted | Mean | Standard Deviation | score on a scale | week 9 |
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| Secondary | Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk. | Posted | Mean | Standard Deviation | meters per second | week 0 |
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| Secondary | Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk. | Posted | Mean | Standard Deviation | meters per second | week 5 |
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| Secondary | Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk. | Posted | Mean | Standard Deviation | meters per second | week 9 |
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| Secondary | Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)]. | Posted | Mean | Standard Deviation | mL/kg/min/m | week 0 |
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| Secondary | Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)]. | Data for this outcome measure were not collected for 2 participants. | Posted | Mean | Standard Deviation | mL/kg/min/m | week 5 |
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| Secondary | Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)]. | Posted | Mean | Standard Deviation | mL/kg/min/m | week 9 |
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| 0 |
| 15 |
| 1 |
| 15 |
| 8 |
| 15 |
| Skin pinch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| High blood pressure | General disorders | Non-systematic Assessment |
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| Device non-function | Investigations | Non-systematic Assessment |
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Not provided
Not provided
Not provided
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| Affected Knee flexion-extension |
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| Affected Knee abduction-adduction |
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| Affected Knee internal-external rotation |
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| Affected Ankle flexion-extension |
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| Affected Ankle abduction-adduction |
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| Affected Ankle internal-external rotation |
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| Unaffected Hip flexion-extension |
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| Unaffected Hip abduction-adduction |
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| Unaffected Hip internal-external rotation |
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| Unaffected Knee flexion-extension |
|
| Unaffected Knee abduction-adduction |
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| Unaffected Knee internal-external rotation |
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| Unaffected Ankle flexion-extension |
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| Unaffected Ankle abduction-adduction |
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| Unaffected Ankle internal-external rotation |
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| Title | Measurements |
|---|---|
|
| Affected Vastus medialis |
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| Affected Rectus femoris |
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| Affected Biceps femoris |
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| Affected Semimembranous |
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| Unaffected Tibialis anterior |
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| Unaffected Soleus |
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| Unaffected Medial gastrocnemius |
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| Unaffected Vastus medialis |
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| Unaffected Rectus femoris |
|
| Unaffected Biceps femoris |
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| Unaffected Semimembranous |
|
| Title | Measurements |
|---|---|
|
| Affected Vastus medialis |
|
| Affected Rectus femoris |
|
| Affected Biceps femoris |
|
| Affected Semimembranous |
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| Unaffected Tibialis anterior |
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| Unaffected Soleus |
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| Unaffected Medial gastrocnemius |
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| Unaffected Vastus medialis |
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| Unaffected Rectus femoris |
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| Unaffected Biceps femoris |
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| Unaffected Semimembranous |
|
| Title | Measurements |
|---|---|
|
| Affected side hip external rotation |
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| Affected side hip abduction |
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| Affected side hip adduction |
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| Unaffected side hip flexion |
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| Unaffected side hip extension |
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| Unaffected side hip internal rotation |
|
| Unaffected side hip external rotation |
|
| Unaffected side hip abduction |
|
| Unaffected side hip adduction |
|
| Title | Measurements |
|---|---|
|
| Affected side hip external rotation |
|
| Affected side hip abduction |
|
| Affected side hip adduction |
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| Unaffected side hip flexion |
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| Unaffected side hip extension |
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| Unaffected side hip internal rotation |
|
| Unaffected side hip external rotation |
|
| Unaffected side hip abduction |
|
| Unaffected side hip adduction |
|
| Title | Measurements |
|---|---|
|
| Unaffected side knee extension |
|
| Title | Measurements |
|---|---|
|
| Unaffected side knee extension |
|
| Title | Measurements |
|---|---|
|
| Unaffected side ankle plantarflexion |
|
| Title | Measurements |
|---|---|
|
| Unaffected side ankle plantarflexion |
|
| Title | Measurements |
|---|---|
|
| Affected side knee extensors |
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| Affected side ankle dorsiflexors |
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| Affected side ankle plantarflexors |
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| Unaffected side hip flexor |
|
| Unaffected side hip extensor |
|
| Unaffected side knee flexors |
|
| Unaffected side knee extensors |
|
| Unaffected side ankle dorsiflexors |
|
| Unaffected side ankle plantarflexors |
|
| Title | Measurements |
|---|---|
|
| Affected side knee extensors |
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| Affected side ankle dorsiflexors |
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| Affected side ankle plantarflexors |
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| Unaffected side hip flexor |
|
| Unaffected side hip extensor |
|
| Unaffected side knee flexors |
|
| Unaffected side knee extensors |
|
| Unaffected side ankle dorsiflexors |
|
| Unaffected side ankle plantarflexors |
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