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| Name | Class |
|---|---|
| Shepherd Center, Atlanta GA | OTHER |
| Cedars-Sinai Medical Center | OTHER |
| Sheltering Arms Physical Rehabilitation Hospitals | OTHER |
| Shirley Ryan AbilityLab |
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The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Subjects | Experimental | All enrolled subjects will receive gait training with the Indego. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indego Exoskeleton | Device | Six study sessions including five Indego training sessions over two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events | Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale | Spasticity measured with Modified Ashworth Scale (MAS) 0 - No increase in muscle tone 1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 - More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 - Considerable increase in muscle tone, passive movement difficult 4 - Affected part(s) rigid in flexion or extension |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Health System | Los Angeles | California | 90048 | United States | ||
| Shepherd Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks. |
| 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 | Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events | Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events | Posted | Number | Events | 2 weeks |
|
|
2 weeks
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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 | All Enrolled Subjects | All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment | Patient was admitted to hospital for urinary retention that was resolved with foley catheter. Adverse Event determined to be unrelated to study and device.Subject withdrew from study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of balance | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan J. Farris, Ph.D., P.E. | Parker Hannifin Corporation | 2168963335 | ryan.farris@parker.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 | Oct 25, 2016 | Apr 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| Kessler Foundation | OTHER |
| St. Charles Hospital | UNKNOWN |
| TIRR Memorial Hermann | OTHER |
| Rusk Rehabilitation | UNKNOWN |
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| 2 weeks |
| Activity Measured by Functional Ambulation Category | Activity measured by Functional Ambulation Category (FAC)
| 2 weeks |
| Gait Speed (Without Indego) Measured With 10 Meter Walk Test | 10 Meter Walk Test (MWT) without Indego to measure gait speed | 2 weeks |
| Pain Measured With Face, Legs, Activity, Cry, Consolability Scale | Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile
Legs 0: normal position or relaxed
Activity 0: lying quietly, normal position, moves easily
Cry 0: no cry (awake or asleep)
Consolability 0: content, relaxed
Minimum score: 0 Maximum Score: 10 | 2 weeks |
| Atlanta |
| Georgia |
| 30309 |
| United States |
| Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab) | Chicago | Illinois | 60611 | United States |
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
| St. Charles Hospital | Port Jefferson | New York | 11777 | United States |
| TIRR Memorial Hermann | Houston | Texas | 77030 | United States |
| Sheltering Arms Physical Rehabilitation Centers | Mechanicsville | Virginia | 23116 | United States |
| High Blood Pressure |
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| Change in Status |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Acuity of Cerebrovascular Accident (CVA) | Acute: less than 2 months since CVA, Sub-acute: 2-6 months since CVA, or Chronic: more than 6 months since CVA | Count of Participants | Participants |
|
| Severity of Cerebrovascular Accident (CVA) | Mild: Fugl-Meyer Motor Assessment score greater than 79, Moderate: Fugl-Meyer Motor Assessment score 56-79, Severe: Fugl-Meyer Motor Assessment score 36-55, or Very Severe: Fugl-Meyer Motor Assessment score 0-35 | Count of Participants | Participants |
|
|
| Secondary | Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale | Spasticity measured with Modified Ashworth Scale (MAS) 0 - No increase in muscle tone 1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 - More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 - Considerable increase in muscle tone, passive movement difficult 4 - Affected part(s) rigid in flexion or extension | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Activity Measured by Functional Ambulation Category | Activity measured by Functional Ambulation Category (FAC)
| Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Gait Speed (Without Indego) Measured With 10 Meter Walk Test | 10 Meter Walk Test (MWT) without Indego to measure gait speed | Posted | Mean | Standard Deviation | seconds | 2 weeks |
|
|
|
| Secondary | Pain Measured With Face, Legs, Activity, Cry, Consolability Scale | Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile
Legs 0: normal position or relaxed
Activity 0: lying quietly, normal position, moves easily
Cry 0: no cry (awake or asleep)
Consolability 0: content, relaxed
Minimum score: 0 Maximum Score: 10 | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 0 |
| 48 |
| 3 |
| 48 |
| 3 |
| 48 |
|
| High blood pressure | General disorders | Systematic Assessment | Patient came to first Indego session and had BP 180/125. Patient admitted to hospital and they indicated that they forgot to take their BP medication that morning. Adverse Event determined to be unrelated to study/device. Subject withdrew from study. |
|
| Deep vein thrombosis | General disorders | Systematic Assessment | Patient was admitted to hospital for lower extremity deep vein thrombosis after being consented for study but before beginning first session. Adverse Event determined to be unrelated to study and device. Subject withdrew from study. |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment | Patient noted posterior loss of balance falling after attempting to retrieve pillow off ground at home while gripping walker. Determined to be unrelated to study and device. |
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| Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Subject had skin abrasion from personal AFO use on left lateral calf. Area did not come in contact with Indego and was present prior to use. |
|
| Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Additional areas of breakdown and blisters from subject's personal AFO developed over the weekend (between Indego sessions). |
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| Fall | General disorders | Systematic Assessment | Patient reported fall out of wheelchair. Determined to be unrelated to study and device. |
|
| Change in status | General disorders | Systematic Assessment | Patient had been consented for study but upon arriving for first session subject had poor verbal responsiveness with increased pushing behavior. Change in status determined to be unrelated to study and device. Subject withdrew from study. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Average MAS Left LE Session 1 |
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| Average MAS Right UE Session 6 |
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| Average MAS Left UE Session 6 |
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| Average MAS Right LE Session 6 |
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| Average MAS Left LE Session 6 |
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