Soft Robotic Hand System for Stroke Rehabilitation

May 17, 2022 updated by: Raymond KY Tong, Chinese University of Hong Kong
The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • Department of Biomedical Engineering, The Chinese University of Hong Kong
        • Contact:
          • Raymond Tong, PhD
          • Phone Number: +852 3943 8454

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);
  2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
  3. able to sit up for 45 minutes (with or without assistance).

Exclusion criteria:

  1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication;
  2. any additional medical or psychological condition affecting their ability to comply with the study protocol;
  3. history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMG-driven soft robot hand
subjects will receive EMG-driven soft robot hand system.
Device: soft robot hand system
subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.
Placebo Comparator: sham group
subjects will receive passive pre-programmed soft robot hand system.
Device: soft robot hand system
subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Upper limb Fugl Meyer Assessment
Time Frame: 3-month follow up
3-month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: 3-month follow up
3-month follow up
Modified Ashworth Scale
Time Frame: 3-month follow up
Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension
3-month follow up
Box and Block Test
Time Frame: 3-month follow up
3-month follow up
Max Voluntary Grip Force
Time Frame: 3-month follow up
3-month follow up

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Raymond Kai-yu Tong, PhD, Department of Biomedical Engineering, CUHK

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)

April 12, 2018

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017.396-T

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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