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
Not provided
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RE | Experimental | Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as both an inpatient (2 days a week RE) and an outpatient (3 days a week RE). |
|
| SOC | Active Comparator | Participants receive standard of care gait training only as both an inpatient (at least 2 days a week) and an outpatient (at least 3 days a week). |
|
| RE/SOC | Experimental | Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as an inpatient (2 days a week RE) and standard of care only as an outpatient (at least 3 days a week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RE (Robotic Exoskeleton) | Device | Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). 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. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | a conventional assessment measure of motor function | 6 months |
| TUG | time up and go (TUG) test | 6 months |
| BBA | Berg Balance Assessment (BBA) | 6 months |
| ROM | range of motion (ROM)- conventional assessment performed by a physical therapist | 6 months |
| strength | conventional assessment performed by a physical therapist | 6 months |
| temporal spatial parameters | collected though motion capture camera system | 6 months |
| plantar loading | use of shoe insoles to gather information about foot pressure | 6 months |
| electromyography (EMG) | a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support). | 6 months |
| SIS |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Unable to physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen J Nolan, 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 |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SOC (standard of care) | Other | Traditional physical therapist driven gait training. |
|
stroke impact scale (SIS). questionnaire about quality of life post-stroke
| 6 months |
| LIFE-H | assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke | 6 months |
| SSQoL | stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke | 6 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |