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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
Near normal range-of-motion for the knees, hips, and ankles
Males and Females 18 years of age or older post-stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post tests up to six weeks apart
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can move your knees, hips, and ankles almost like most people can.
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Adults who have had a stroke and are 18 years old or older.
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You have a score of 3 on the Ashworth scale when standing.
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You weigh less than 220 pounds and are between 5 feet and 6 feet 4 inches tall.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6 minute walk test
Berg Balance Test
Ten meter walk test
+2 more

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.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
304 Previous Clinical Trials
259,452 Total Patients Enrolled
4 Trials studying Stroke
88 Patients Enrolled for Stroke
Michael Davidson, MSE MPHPrincipal Investigator - Loma Linda University O&P
Loma Linda University
1 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

Hybrid combination of physical therapy and powered exoskeleton Clinical Trial Eligibility Overview. Trial Name: NCT04648878 — N/A
Stroke Research Study Groups: Group A - Hybrid combination, Group B - Powered Exoskeleton only, Group C - Physical Therapy only
Stroke Clinical Trial 2023: Hybrid combination of physical therapy and powered exoskeleton Highlights & Side Effects. Trial Name: NCT04648878 — N/A
Hybrid combination of physical therapy and powered exoskeleton 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648878 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intake capacity for this clinical experiment?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial is currently searching for participants, which was first made available on February 14th 2021 and updated as recently as April 5th 2022. The project aims to recruit 36 people from a single site of care."

Answered by AI

Is enrollment for this clinical investigation available at present?

"Affirmative, the data hosted on clinicaltrials.gov suggests that this medical study is currently recruiting volunteers. Initially posted on February 14th 2021 and revised most recently on April 5th 2022, 36 participants are needed at a single site for enrolment."

Answered by AI
~7 spots leftby Dec 2024