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Behavioural Intervention

Robotic Training + FES vs Robotic Training Alone for Stroke Recovery

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Age 22-85 years old

Ability to perform an Upper Extremity forward reach of about 3 inches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline wmft at 6 weeks

Awards & highlights

Study Summary

This trial tests if combining FES & Robot rehab helps improve upper extremity function in stroke patients more than Robot rehab alone.

Who is the study for?

This trial is for adults aged 22-85 who've had a stroke over 6 months ago and can reach forward about 3 inches with their arm. It's not suitable for those with implants like pacemakers, other upper limb issues, intolerance to electrical stimulation, recent Botox injections in the area, or severe elbow contracture.Check my eligibility

What is being tested?

The study tests if combining Functional Electrical Stimulation (FES) with robotic training improves arm function after stroke better than robotic training alone. Participants will be divided into two groups: one receiving both FES and robot-assisted therapy, and the other only robot-assisted therapy.See study design

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation or muscle fatigue due to exercise. The robotic device could also cause minor bruising or skin irritation at contact points during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 85 years old.

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I can reach forward with my arm about 3 inches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline smoothness at 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline smoothness at 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline smoothness at 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Kinematic Assessment:Range of Motion(ROM) in cms

Kinematic Assessment:Smoothness in 1/s2

Kinematic Assessment:Speed in cm/seconds

Secondary outcome measures

Fugl-Meyer Upper Extremity(FMA-UE)

Modified Ashworth Scale of muscle spasticity (MAS)

Wolf Motor Function Test (WMFT)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hybrid multi-muscle FES+RobotExperimental Treatment1 Intervention

Participants will be receive hybrid upper extremity training involving the combination of REACH robotic device and multi-muscle FES. Water based electrodes will be positioned on the Triceps, Anconeus, wrist and finger extensors. Stimulation intensity of FES will be set at the participants tolerance level. The FES induced muscle contraction timing will be triggered in synchrony with the robotic movement. The training will be a multi-directional reach movement and hand opening re-training.

Group II: Robot onlyActive Control1 Intervention

Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,632 Total Patients Enrolled

10 Trials studying Stroke

1,447 Patients Enrolled for Stroke

Media Library

Multi-muscle FES (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05854485 — N/A

Stroke Research Study Groups: Hybrid multi-muscle FES+Robot, Robot only

Stroke Clinical Trial 2023: Multi-muscle FES Highlights & Side Effects. Trial Name: NCT05854485 — N/A

Multi-muscle FES (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854485 — N/A

Frequently Asked Questions

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

Is this investigation enrolling individuals of 35 years or greater?

"The age range for prospective participants in this medical study is 22 to 85 years old."

Answered by AI

Is there any availability for participation in this medical research?

"The information hosted on clinicaltrials.gov indicates that this trial has concluded its recruitment process, with the last edit being made on May 2nd 2023. Despite not recruiting anymore, there are 1068 other studies which remain actively looking for participants as of now."

Answered by AI

Who qualifies to enroll in this trial protocol?

"To participate in this medical experiment, individuals must have experienced a stroke and be between the ages of 22-85. Moreover, there are 24 available slots for enrollment."

Answered by AI

Recent research and studies

Neurorehabilitation and Neural RepairJournal

Intensive Sensorimotor Arm Training Mediated by Therapist or Robot Improves Hemiparesis in Patients with Chronic Stroke

Volpe, Bruce T., Daniel Lynch, Avrielle Rykman-Berland, Mark Ferraro, Michael Galgano, Neville Hogan, and Hermano I. Krebs. 2008. “Intensive Sensorimotor Arm Training Mediated by Therapist or Robot Improves Hemiparesis in Patients with Chronic Stroke”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968307311102.

clinicaltrials.govStudy

Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

Kelly Westlake 2023. "Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05854485.