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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 week

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 week

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

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

Primary outcome measures

6 minutes walking test

Dorsiflexion active range of motion

Fugl-Meyer Lower Extremity

+2 more

Secondary outcome measures

10-meter walk test (10MWT)

Brief Balance Evaluation Systems Test(Brief-BESTest)

Modified Ashworth Scale (MAS)

+3 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,596 Total Patients Enrolled

10 Trials studying Stroke

1,411 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

Frequently Asked Questions

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

Does the current research protocol welcome elderly individuals as participants?

"According to the prerequisites of this study, participants must be 18 or older and no more than 85 years old."

Answered by AI

Do I fulfill the qualifications to participate in this research?

"This study requires recruiting 60 stroke patients, aged between 18 and 85. In addition to this criteria, participants must have a caregiver for at-home training support as well as be capable of independently ambulating 10 metres with or without the use of an assistive device in the 6 months since their stroke episode."

Answered by AI

What is the cap on enrolment for this medical experiment?

"Yes, the information hosted on clinicaltrials.gov verifies that this medical trial is actively seeking participants. It was first posted on August 1st 2021 and most recently modified on October 4th 2022. This study requires 60 volunteers at a singular location."

Answered by AI

With what results is this medical experiment hoping to conclude?

"The purpose of this trial, which will be observed over a 12 week period, is to evaluate participants' performance on the 6 Minute Walking Test. Other metrics that are being used to determine objective results include the Brief Balance Evaluation Systems Test (Brief-BESTest), 10 Meter Walk Test (10MWT) and Stroke Rehabilitation Assessment of Movement Measure (STREAM)."

Answered by AI

Does this research endeavor have any openings for volunteer participants?

"According to information hosted on clinicaltrials.gov, this trial is currently enrolling participants. The initial listing was posted August 1st 2021 and the last update occurred October 4th 2022."

Answered by AI

Recent research and studies

IEEE Transactions on Neural Systems and Rehabilitation EngineeringJournal

Intelligent Stretching of Ankle Joints with Contracture/spasticity

Li-Qun Zhang, S.G. Chung, Zhiqiang Bai, Dali Xu, E.M.T. van Rey, M.W. Rogers, M.E. Johnson, and E.J. Roth. 2002. “Intelligent Stretching of Ankle Joints with Contracture/spasticity”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2002.802857.

Archives of Physical Medicine and RehabilitationJournal

Functional Electrical Stimulation to Dorsiflexors and Plantar Flexors During Gait to Improve Walking in Adults with Chronic Hemiplegia

Embrey, David G., Sandra L. Holtz, Gad Alon, Brenna A. Brandsma, and Sarah Westcott McCoy. 2010. “Functional Electrical Stimulation to Dorsiflexors and Plantar Flexors During Gait to Improve Walking in Adults with Chronic Hemiplegia”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2009.12.024.

IEEE Transactions on Neural Systems and Rehabilitation EngineeringJournal

Developing a Wearable Ankle Rehabilitation Robotic Device for In-bed Acute Stroke Rehabilitation

Ren, Yupeng, Yi-Ning Wu, Chung-Yong Yang, Tao Xu, Richard L. Harvey, and Li-Qun Zhang. 2017. “Developing a Wearable Ankle Rehabilitation Robotic Device for In-bed Acute Stroke Rehabilitation”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2016.2584003.

Archives of Physical Medicine and RehabilitationJournal