Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.
The purpose of this research study is to assess whether using a wearable device, called the robotic exoskeleton (RE), can be helpful in improving recovery of walking in adults who have recently had a stroke. The study will compare the walking abilities of people who went through standard of care treatment after a stroke to those who used the robotic exoskeleton as part of their rehabilitation. This study will also look at the effects walking in the RE has on brain activity. The name of the robotic exoskeleton that is being used in this study is the EksoTM.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke RE | Experimental | After discharge from the acute rehabilitation facility, participants in the stroke RE group will participate 3 days a week for 10 weeks in robotic exoskeleton gait training provided by a trained, licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own. |
|
| Stroke SOC | Active Comparator | After discharge from the acute rehabilitation facility, participants in the stroke SOC group will participate 3 days a week for 10 weeks in standard of care gait training provided by a licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own. |
|
| Healthy Control | Other | Participants in the healthy control group will not participate in any gait training. Healthy control participants will only be asked to complete 3 testing sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EksoGTâ„¢, Ekso Bionics, Berkley, CA, USA | Device | The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) (aim 1) | a conventional assessment measure of motor function | Change from Baseline FIM at 10 weeks |
| Within-brain functional connectivity (aim 2) | fMRI connectivity between selected regions of interest within the sensorimotor and attention networks. | Change from Baseline Within-brain functional connectivity at 10 weeks |
| TMS recruitment curve slope (aim 3) | A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds. | Change from Baseline TMS recruitment curve slope at 10 weeks |
| electroencephalogram (EEG) (aim 3) | a measure of brain activation at different phases of gait cycle (swing versus double support). | Change from Baseline EEG at 10 weeks |
| electromyography (EMG) (aim 3) | a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support). | Change from Baseline EMG at 10 weeks |
| 10MWT (aims 1-3) | 10 meters walking test to evaluate walking speedafter stroke and in response to the intervention. | Change from Baseline 10MWT at 10 weeks |
| 6MWT (aims 1-3) | 6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen J. Nolan, PhD | Kessler Foundation | Principal Investigator |
| Soha Saleh, PhD | Kessler Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Other | Standard gait therapy provided by licensed physical therapists post stroke. |
|
| No Intervention | Other | Testing Only |
|
| Change from Baseline 6MWT at 10 weeks |
| TUG (aims 1-3) | time up and go (TUG) test | Change from Baseline TUG at 10 weeks |
| structural connectivity (aim 2) | Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity | Change from Baseline structural connectivity at 10 weeks |