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Exoskeleton-Assisted Rehabilitation for Stroke

N/A

Recruiting

Led By Michael Davidson, MSE MPH

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre and post tests up to six weeks apart

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if powered exoskeleton therapy can help improve quality of life for stroke patients as part of their rehabilitation program.

Who is the study for?

This trial is for adults over 18 who've had a stroke, can follow simple commands, and are within certain height and weight limits. They should have near-normal joint movement in legs and be part of a standing program. People who've already tried exoskeleton therapy can't join.

What is being tested?

The study compares three types of stroke rehabilitation: standard physical therapy, using a powered exoskeleton, or a mix of both. It aims to see if including the exoskeleton in treatment could become common practice for better recovery.

What are the potential side effects?

Potential side effects may include muscle soreness, fatigue from physical exertion during therapy sessions, skin irritation from the exoskeleton device, or discomfort due to unfamiliarity with the equipment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre and post tests up to six weeks apart

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre and post tests up to six weeks apart

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post tests up to six weeks apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6 minute walk test

Berg Balance Test

Ten meter walk test

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group C - Physical Therapy onlyExperimental Treatment1 Intervention

Group C (n=12) will receive 18 visits of physical therapy, three times a week for approximately 6 weeks. Upon completion of the data collection portion of the study, group C will receive 9 sessions, three times a week for approximately three weeks of powered exoskeleton therapy. Data will not be collected or reported during this phase, but but may be retained for future approved use.

Group II: Group B - Powered Exoskeleton onlyExperimental Treatment1 Intervention

Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks.

Group III: Group A - Hybrid combinationExperimental Treatment1 Intervention

Group A (n=12) will receive 18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks.

Do I qualify?Apply below to find out