Comparing robotic exoskeleton therapy with high-intensity walking training for stroke recovery

Comparing Effects of Conventional Neurorehabilitation with Exoskeleton with High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

This study is testing whether using a robotic exoskeleton or high-intensity walking training helps stroke patients recover their walking ability and improve their mental health better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alvernia University (other)
• Locations: 1 site (Allentown, Pennsylvania)
• Trial ID: NCT06478680 on ClinicalTrials.gov

What this trial studies

This research aims to compare the effectiveness of rehabilitation using a robotic exoskeleton against high-intensity gait training that maintains a target heart rate during therapy sessions. Participants will undergo 20 interventions to assess improvements in walking function and mental health. Additionally, the study will evaluate how factors like mental health, social support, and health literacy influence attendance at physical therapy sessions. The goal is to determine which approach yields better outcomes for stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke and are referred to the outpatient physical therapy clinic.

Not a fit: Patients who are unable to follow simple commands or have severe physical limitations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance rehabilitation strategies for stroke patients, leading to improved walking function and mental health.

How similar studies have performed: Other studies have shown promising results with robotic exoskeletons in rehabilitation, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Allentown, Pennsylvania

• Good Shepherd Rehabilitation — Allentown, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Soo Yeon Sun, PhD — Alvernia University
• Study coordinator: Soo Yeon Sun, PhD

Conditions: Stroke, Gait, Hemiplegic, health literacy, balance, compliance to therapy, gait function, high intensity gait training, exoskeleton