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The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.
Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| robot assisted training (RAT) | Experimental | RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities |
|
| conventional training (CT) | Active Comparator | Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot assisted gait therapy | Other | The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Score | Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity. | baseline |
| Fatigue Severity Score | Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity. | after treatment (4th week) |
| Fatigue Severity Score | Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity. | 3 months after treatment |
| Hospital Anxiety Depression Scale-Depression Subscale (HADS-D) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression. | Baseline |
| Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Abdulhamid Han Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27762641 | Background | Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20. | |
| 28241776 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Robot Assisted Gait | robot assisted gait therapy: The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton. |
| FG001 | Conventional Rehabilitation | Conventional rehabilitation: Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robot Assisted Training (RAT) | RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities |
| BG001 | Conventional Training (CT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Fatigue Severity Score | Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity. | Posted | Median | Full Range | score on a scale | baseline |
|
Adverse Events were not monitored/assessed
Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robot Assisted Training (RAT) | RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tugba Ozsoy | Sultan Abdulhamid Han Training and Research Hospital | +902165422020 | 3876 | tugbaozsoyy@gmail.com |
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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 1, 2020 | Feb 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Initial assessments will be performed by first clinician (EA). Then, patients will be randomly grouped. The outcome assessor, second clinician (TOU) will be blinded.
| Conventional rehabilitation | Other | Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists. |
|
| After treatment (4th week) |
| Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression. | 3 months after treatment |
| Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. | baseline |
| Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. | After treatment (4th week) |
| Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. | 3 months after treatment |
| baseline |
| Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL. | after treatment (4th week) |
| Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL. | 3 months after treatment |
| Expanded Disability Status Scale (EDSS) | The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | baseline |
| Expanded Disability Status Scale (EDSS) | The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | after treatment (4th week) |
| Expanded Disability Status Scale (EDSS) | The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | 3 months after treatment |
| Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | baseline |
| Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | after treatment (4th week) |
| Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | 3 months after treatment |
| Walking Ability | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | baseline |
| Walking Ability | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | after treatment (4th week) |
| Walking Ability | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | 3 months after treatment |
| Berg Balance Test (BBT) | Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance. | Baseline |
| Berg Balance Test (BBT) | Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance. | After treatment (4th week) |
| Berg Balance Test (BBT) | Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance. | 3 months after treatment |
| Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2. |
| 24904361 | Background | Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014. |
| 34686632 | Derived | Ozsoy-Unubol T, Ata E, Cavlak M, Demir S, Candan Z, Yilmaz F. Effects of Robot-Assisted Gait Training in Patients With Multiple Sclerosis: A Single-Blinded Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):768-774. doi: 10.1097/PHM.0000000000001913. Epub 2021 Oct 21. |
Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Disease duration | Mean | Standard Deviation | years |
|
Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
|
|
| Primary | Fatigue Severity Score | Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity. | Posted | Median | Full Range | score on a scale | after treatment (4th week) |
|
|
|
| Primary | Fatigue Severity Score | Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity. | Posted | Median | Full Range | score on a scale | 3 months after treatment |
|
|
|
| Primary | Hospital Anxiety Depression Scale-Depression Subscale (HADS-D) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression. | Posted | Median | Full Range | score on a scale | Baseline |
|
|
|
| Primary | Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression. | Posted | Median | Full Range | score on a scale | After treatment (4th week) |
|
|
|
| Primary | Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression. | Posted | Median | Full Range | score on a scale | 3 months after treatment |
|
|
|
| Primary | Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. | Posted | Median | Full Range | score on a scale | baseline |
|
|
|
| Primary | Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. | Posted | Median | Full Range | score on a scale | After treatment (4th week) |
|
|
|
| Primary | Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. | Posted | Median | Full Range | score on a scale | 3 months after treatment |
|
|
|
| Secondary | Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL. | Posted | Median | Full Range | score on a scale | baseline |
|
|
|
| Secondary | Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL. | Posted | Median | Full Range | score on a scale | after treatment (4th week) |
|
|
|
| Secondary | Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL. | Posted | Median | Full Range | score on a scale | 3 months after treatment |
|
|
|
| Secondary | Expanded Disability Status Scale (EDSS) | The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Posted | Median | Full Range | units on a scale | baseline |
|
|
|
| Secondary | Expanded Disability Status Scale (EDSS) | The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Posted | Median | Full Range | units on a scale | after treatment (4th week) |
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|
|
| Secondary | Expanded Disability Status Scale (EDSS) | The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Posted | Median | Full Range | units on a scale | 3 months after treatment |
|
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| Secondary | Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | Posted | Median | Full Range | score on a scale | baseline |
|
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| Secondary | Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | Posted | Median | Full Range | score on a scale | after treatment (4th week) |
|
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| Secondary | Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | Posted | Median | Full Range | score on a scale | 3 months after treatment |
|
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| Secondary | Walking Ability | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | Posted | Median | Full Range | meters | baseline |
|
|
|
| Secondary | Walking Ability | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | Posted | Median | Full Range | meters | after treatment (4th week) |
|
|
|
| Secondary | Walking Ability | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | Posted | Median | Full Range | meters | 3 months after treatment |
|
|
|
| Secondary | Berg Balance Test (BBT) | Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance. | Posted | Median | Full Range | score on a scale | Baseline |
|
|
|
| Secondary | Berg Balance Test (BBT) | Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance. | Posted | Median | Full Range | score on a scale | After treatment (4th week) |
|
|
|
| Secondary | Berg Balance Test (BBT) | Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance. | Posted | Median | Full Range | score on a scale | 3 months after treatment |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Conventional Training (CT) | Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |