Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke

Kessler Foundation2 个研究点分布在 1 个国家目标入组 96 人开始时间: 2025年5月15日最近更新: 2025年9月2日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 96
试验地点: 2
主要终点: 10MWT (Aim 1)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 50 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

结局指标

主要结局

10MWT (Aim 1)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)