Post Stroke Ambulation Recovery Using Robotic Exoskeletons
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic Exoskeleton, SOC.
- Who it may be relevant to
- Registry conditions: Hemiparesis After Stroke. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke
Overview
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
- Device Robotic Exoskeleton
EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA - Other SOC
Standard of Care
Primary outcome measures
- 10MWT (Aim 1) [Time frame: Change from Baseline 10MWT at 4 weeks]
- 6MWT (Aim 1) [Time frame: Change from Baseline 6MWT at 4 weeks]
- TUG (Aim 1) [Time frame: Change from Baseline TUG at 4 weeks]
- DGI (Aim 1) [Time frame: Change from Baseline DGI at 4 weeks]
- Berg Balance Scale (Aim 1) [Time frame: Change from Baseline Berg at 4 weeks]
- Joint Range of Motion (kinematics) (Aim 2) [Time frame: Change from Baseline at 4 weeks]
- Temporospatial Loading (Aim 2) [Time frame: Change from Baseline at 4 weeks]
- Balance (Aim 2) [Time frame: Change from Baseline at 4 weeks]
- Survey for Community Participation (Aim 3) [Time frame: Change from Baseline at 4 weeks]
- Survey for Quality of Life (Aim 3) [Time frame: Change from Baseline at 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kessler Foundation — West Orange
Identifiers
NCT: NCT06736171 · R-1275-24