Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

January 28, 2024 updated by: Xiaoling Hu, The Hong Kong Polytechnic University

Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.

The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:
        • Principal Investigator:
          • Xiaoling Hu, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For the subacute groups:

  • Two weeks after the onset of stroke, however less than 0.5 year
  • Mini-Mental State Examination (MMSE)>21
  • Able to sit up for at least 1 hour
  • Fugl-Meyer Assessment (FMA) upper limb <30
  • Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
  • Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)

For the chronic device assisted group:

  • At least 0.5 year after the onset of stroke
  • Mini-Mental State Examination (MMSE)>21
  • Able to sit up for at least 1 hour
  • Fugl-Meyer Assessment (FMA) upper limb <30
  • Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
  • Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)

Exclusion Criteria:

Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:

  • Currently pregnant
  • Dysphasia (language deficiency)
  • Post-stroke neglect
  • Pacemaker implantation,
  • Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb
  • The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subacute device assisted group
Device: Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
Active Comparator: subacute conventional group
Device: Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
Other: chronic device assisted group
Device: Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
Time Frame: For each subject, the FMA score will be measured one day before the training.
For each subject, the FMA score will be measured one day before the training.
Fugl-Meyer Assessment (FMA) of the Upper Limb after the training
Time Frame: For each subject, the FMA score will be measured one day after the 20-session training program.
For each subject, the FMA score will be measured one day after the 20-session training program.
Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up
Time Frame: For each subject, the FMA score will be measured 3 months later after the last day of the training.
For each subject, the FMA score will be measured 3 months later after the last day of the training.

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
Action Research Arm Test (ARAT)
Time Frame: For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITS/073/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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