Clinical trial NCT06736171: Post Stroke Ambulation Recovery Using Robotic Exoskeletons
Official title: Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiparesis After Stroke
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&amp; quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).

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\&#34; and 76\&#34; 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.

Primary outcomes:
measure: 10MWT (Aim 1)
timeFrame: Change from Baseline 10MWT at 4 weeks
measure: 6MWT (Aim 1)
timeFrame: Change from Baseline 6MWT at 4 weeks
measure: TUG (Aim 1)
timeFrame: Change from Baseline TUG at 4 weeks
measure: DGI (Aim 1)
timeFrame: Change from Baseline DGI at 4 weeks
measure: Berg Balance Scale (Aim 1)
timeFrame: Change from Baseline Berg at 4 weeks
measure: Joint Range of Motion (kinematics) (Aim 2)
timeFrame: Change from Baseline at 4 weeks
measure: Temporospatial Loading (Aim 2)
timeFrame: Change from Baseline at 4 weeks
measure: Balance (Aim 2)
timeFrame: Change from Baseline at 4 weeks
measure: Survey for Community Participation (Aim 3)
timeFrame: Change from Baseline at 4 weeks
measure: Survey for Quality of Life (Aim 3)
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: