Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training

Alvernia University

Status: Terminated

Conditions: Stroke; Gait, Hemiplegic

Treatments: Behavioral: Exoskeleton mediated gait training; Behavioral: High intensity gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT06478680

2176775-1

Details and patient eligibility

About

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• English or Spanish-speaking
• A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
• Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic

Exclusion criteria

• Unable to follow 1-step commands
• > 220 pounds (100 kg)
• Height < 5'0" or > 6'4"
• Unable to take a few steps with assistance
• A score of ≥ 50/56 on Berg Balance Scale (BBS)
• A score of ≥ 26/30 on Functional Gait Assessment (FGA)
• Resting blood pressure >180/110 mmHg
• Resting heart rate > 120 bpm
• Severe cardiac disease (New York Heart Association Classification IV)
• Severe spasticity (Modified Ashworth score > 3)
• Unstable spine or unhealed pelvic/limb fractures
• Active heterotrophic ossification impacting lower extremity range of motion
• Significant lower or upper extremity contractures
• Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
• Pregnancy
• Colostomy
• Poor skin integrity in areas in contact with the EksoGTTM
• Unresolved deep vein thrombosis
• Lower limb prosthesis or amputation
• Leg length discrepancies > 0.5 inches for upper legs, 0.75 inches for lower legs
• ROM restrictions preventing normal, reciprocal gait
• Inability to stand for > 3 minutes due to pain or orthostatic hypotension
• Pusher syndrome
• Cortical blindness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

High intensity gait training

Active Comparator group

Description:

One session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week

Treatment:

Behavioral: High intensity gait training

Exoskeleton mediated gait training

Experimental group

Description:

Two sessions of High-Intensity Gait Training

Treatment:

Behavioral: Exoskeleton mediated gait training