Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to develop and evaluate the use of soft exosuits in patients post stroke.
AIM 1: Develop individualized adaptive controller parameters and a training progression program for these exosuits specific for inpatient stroke rehabilitation.
AIM 2: Evaluate the impact of the soft exosuit + conventional inpatient rehabilitation vs.
conventional inpatient rehabilitation alone on measures of lower-extremity impairments and functional recovery following acute stroke.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIM 1: Single Group (Hip Flexion Soft Exosuit) | Experimental | For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed. |
|
| AIM 2: Device Group (ReWalk ReStore Soft Exosuit) | Experimental | For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. |
|
| AIM 2: Control Group | Active Comparator | Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip flexion soft exosuit | Device | Participants will utilize a Wyss designed hip flexion soft exosuit. This device has a small rope winch at the front of the hip connected to a functional textile waistband and thigh band. It applies an assistive torque in response to wearable sensor measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10 Meter Walk Test | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The data table shows the change in gait speed (meters per second) from admission to discharge, time frame varies based on length of stay (estimated 2-4 weeks). | Admission time-point to discharge time-point (estimated 2-4 weeks). Pre-assessment completed after admission to inpatient rehabilitation, prior to first intervention session. Post-assessment completed following last treatment session, prior to discharge. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AIM 1: Single Group (Hip Flexion Soft Exosuit) | For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed. Hip flexion soft exosuit: Participants will utilize a Wyss designed hip flexion soft exosuit. This device has a small rope winch at the front of the hip connected to a functional textile waistband and thigh band. It applies an assistive torque in response to wearable sensor measurements. |
| FG001 | AIM 2: Device Group (ReWalk ReStore Soft Exosuit) | For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. ReWalk ReStore soft exosuit: Participants will utilize the ReWalk ReStore ankle soft exosuit. This device provides dynamic plantarflexion and dorsiflexion during walking intended to restore paretic limb function resulting in improved gait symmetry, reduced energy cost of walking and improved stability. The exosuits consists of a body-worn actuation unit containing motors, gears, and pulleys that when powered generate forces that are transmitted via Bowden cables to functional textiles anchored proximal and distal to a joint. This actuation occurs in response to signals from embedded wearable sensors. |
| FG002 | AIM 2: Control Group | Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. Conventional physical therapy: Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AIM 1: Single Group (Hip Flexion Soft Exosuit) | For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed. Hip flexion soft exosuit: Participants will utilize a Wyss designed hip flexion soft exosuit. This device has a small rope winch at the front of the hip connected to a functional textile waistband and thigh band. It applies an assistive torque in response to wearable sensor measurements. |
| 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 | Change in 10 Meter Walk Test | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The data table shows the change in gait speed (meters per second) from admission to discharge, time frame varies based on length of stay (estimated 2-4 weeks). | Posted | Mean | Full Range | m/sec | Admission time-point to discharge time-point (estimated 2-4 weeks). Pre-assessment completed after admission to inpatient rehabilitation, prior to first intervention session. Post-assessment completed following last treatment session, prior to discharge. |
|
Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
Not provided
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 | AIM 1: Single Group (Hip Flexion Soft Exosuit) | For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed. Hip flexion soft exosuit: Participants will utilize a Wyss designed hip flexion soft exosuit. This device has a small rope winch at the front of the hip connected to a functional textile waistband and thigh band. It applies an assistive torque in response to wearable sensor measurements. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leave of Absence | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Prokup PT, DPT | Shirley Ryan Abilitylab | 312-238-1355 | sprokup@sralab.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2025 | May 16, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2025 | May 16, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2022 | May 16, 2025 | ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ReWalk ReStore soft exosuit | Device | Participants will utilize the ReWalk ReStore ankle soft exosuit. This device provides dynamic plantarflexion and dorsiflexion during walking intended to restore paretic limb function resulting in improved gait symmetry, reduced energy cost of walking and improved stability. The exosuits consists of a body-worn actuation unit containing motors, gears, and pulleys that when powered generate forces that are transmitted via Bowden cables to functional textiles anchored proximal and distal to a joint. This actuation occurs in response to signals from embedded wearable sensors. |
|
| Conventional physical therapy | Other | Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay. |
|
| BG001 | AIM 2: Device Group (ReWalk ReStore Soft Exosuit) | For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. ReWalk ReStore soft exosuit: Participants will utilize the ReWalk ReStore ankle soft exosuit. This device provides dynamic plantarflexion and dorsiflexion during walking intended to restore paretic limb function resulting in improved gait symmetry, reduced energy cost of walking and improved stability. The exosuits consists of a body-worn actuation unit containing motors, gears, and pulleys that when powered generate forces that are transmitted via Bowden cables to functional textiles anchored proximal and distal to a joint. This actuation occurs in response to signals from embedded wearable sensors. |
| BG002 | AIM 2: Control Group | Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. Conventional physical therapy: Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 10 Meter Walk Test | Mean | Full Range | m/sec |
|
For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed. Hip flexion soft exosuit: Participants will utilize a Wyss designed hip flexion soft exosuit. This device has a small rope winch at the front of the hip connected to a functional textile waistband and thigh band. It applies an assistive torque in response to wearable sensor measurements. |
| OG001 | AIM 2: Device Group (ReWalk ReStore Soft Exosuit) | For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. ReWalk ReStore soft exosuit: Participants will utilize the ReWalk ReStore ankle soft exosuit. This device provides dynamic plantarflexion and dorsiflexion during walking intended to restore paretic limb function resulting in improved gait symmetry, reduced energy cost of walking and improved stability. The exosuits consists of a body-worn actuation unit containing motors, gears, and pulleys that when powered generate forces that are transmitted via Bowden cables to functional textiles anchored proximal and distal to a joint. This actuation occurs in response to signals from embedded wearable sensors. |
| OG002 | AIM 2: Control Group | Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. Conventional physical therapy: Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay. |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | AIM 2: Device Group (ReWalk ReStore Soft Exosuit) | For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. ReWalk ReStore soft exosuit: Participants will utilize the ReWalk ReStore ankle soft exosuit. This device provides dynamic plantarflexion and dorsiflexion during walking intended to restore paretic limb function resulting in improved gait symmetry, reduced energy cost of walking and improved stability. The exosuits consists of a body-worn actuation unit containing motors, gears, and pulleys that when powered generate forces that are transmitted via Bowden cables to functional textiles anchored proximal and distal to a joint. This actuation occurs in response to signals from embedded wearable sensors. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | AIM 2: Control Group | Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling. Conventional physical therapy: Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay. | 0 | 5 | 0 | 5 | 0 | 5 |
| Fall Outside Study Procedures | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |