Hemiparesis After Stroke
Conditions
Brief summary
The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.
Detailed description
This study will systematically compare various commercially available REs and aid in identifying the appropriate devices for gait training prescription in individuals post-stroke based on their deficits. The objective of this study is to evaluate and compare the four groups (3 REs and standard of care treatment) using biomechanical, functional and community participation & quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).
Interventions
DEVICERobotic Exoskeleton
EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
OTHERSOC
Standard of Care
Sponsors
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Stroke survivors 3 - 8 months from a recent stroke. * Age: 50 - 80 years * Unilateral hemiparesis * Medical clearance by the Medical Director * Be able to physically fit into the exoskeleton device: Height between 60" and 76" and weight below 220 lbs * Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation (e.g. can follow directions). * Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback. * Have a joint range of motion within normal functional limits for ambulation. * Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE. * No history of injury or pathology to the unaffected limb. * Have an appropriate walking speed as determined by the study staff.
Exclusion criteria
* Any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity). * Skin issues that would prevent wearing the device. * Pre-existing condition that caused exercise intolerance (documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure). * Hospitalization for heart attack, heart surgery, or acute heart failure within 3 months of enrollment in the study. * Uncontrolled seizure disorder, spasticity, or joint contracture that would interfere with walking. * Neuromuscular, neurological, or orthopedic pathologies that interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10MWT (Aim 1) | Change from Baseline 10MWT at 4 weeks | 10 meter walk test to evaluate walking speed after stroke and in response to the intervention. |
| 6MWT (Aim 1) | Change from Baseline 6MWT at 4 weeks | 6 minute walking test to evaluate endurance after stroke and in response to the intervention |
| TUG (Aim 1) | Change from Baseline TUG at 4 weeks | Timed up and go (TUG) test to measure functional balance and walking ability after stroke and in response to the intervention. |
| DGI (Aim 1) | Change from Baseline DGI at 4 weeks | Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after stroke and in response to the intervention. |
| Berg Balance Scale (Aim 1) | Change from Baseline Berg at 4 weeks | Measure to assess static and dynamic balance and fall risk after stroke and in response to the intervention. |
| Joint Range of Motion (kinematics) (Aim 2) | Change from Baseline at 4 weeks | Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes. |
| Temporospatial Loading (Aim 2) | Change from Baseline at 4 weeks | Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and insoles. |
| Balance (Aim 2) | Change from Baseline at 4 weeks | Static and dynamic balance in standing and seated positions after stroke and in response to the intervention (using Hunova (Movendo Inc, Genova, Italy) plaform). |
| Survey for Community Participation (Aim 3) | Change from Baseline at 4 weeks | The Community Participation Indicators (CPI) is a self-reported 48 item objective measure survey. |
| Survey for Quality of Life (Aim 3) | Change from Baseline at 4 weeks | The SS-QOL survey assesses health-related quality of life (QOL) specific to stroke survivors with 49 items across 12 domains. |
Countries
United States
Contacts
Primary ContactSharon Franco
Backup ContactKathleen Goworek
Outcome results
None listed