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Robotics

Robot-Guided Therapy + FES for Stroke Rehabilitation

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 18-85
Able to ambulate at least 10 meters without human assistance, with or without an assistive device
Must not have
Having severe pain in the paralyzed lower-limb
Having expressive and receptive aphasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a robot-guided stretching and active movement training, combined with functional electrical stimulation, can help increase joint range of motion, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion for stroke survivors with sensorimotor impairments.

Who is the study for?
This trial is for stroke survivors aged 18-85 who can walk at least 10 meters without help, have a caregiver to assist with home training, and are more than 6 months post-stroke. It's not suitable for those with severe lower-limb pain, communication difficulties due to aphasia, inability to follow instructions, current participation in another leg rehab program, significant ankle contracture or implanted electronic devices like pacemakers.
What is being tested?
The study tests a new home-based rehabilitation system combining an ankle robot and functional electrical stimulation (FES) against the ankle robot alone. The goal is to see if this hybrid approach better aids motor recovery and walking ability after a stroke compared to just robotic assistance.
What are the potential side effects?
Potential side effects may include discomfort from the electrical stimulation or skin irritation where electrodes are placed. There might also be muscle fatigue due to exercise and possible soreness from stretching movements during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I can walk 10 meters by myself, with or without help like a cane.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience severe pain in my paralyzed lower limb.
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I have trouble understanding and expressing spoken words.
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I struggle to follow multi-step instructions.
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I am currently in a lower limb rehab program.
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My ankle cannot bend upwards past a certain point.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week 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 minutes walking test
Dorsiflexion active range of motion
Fugl-Meyer Lower Extremity
+2 more
Secondary study objectives
10-meter walk test (10MWT)
Brief Balance Evaluation Systems Test(Brief-BESTest)
Modified Ashworth Scale (MAS)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FES+robotExperimental Treatment1 Intervention
Participants in this group will have FES during ankle robot training
Group II: RobotActive Control1 Intervention
Participants in this group will have ankle robot training only

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,192 Total Patients Enrolled
13 Trials studying Stroke
7,209 Patients Enrolled for Stroke

Media Library

Ankle Robot Training (Robotics) Clinical Trial Eligibility Overview. Trial Name: NCT04550728 — N/A
Stroke Research Study Groups: FES+robot, Robot
Ankle Robot Training (Robotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04550728 — N/A
~21 spots leftby Oct 2026
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