search
Back to results

Soft Robotic Hand System for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
soft robot hand system
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EMG-driven soft robot hand

sham group

Arm Description

subjects will receive EMG-driven soft robot hand system.

subjects will receive passive pre-programmed soft robot hand system.

Outcomes

Primary Outcome Measures

Upper limb Fugl Meyer Assessment

Secondary Outcome Measures

Action Research Arm Test
Modified Ashworth Scale
Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension
Box and Block Test
Max Voluntary Grip Force

Full Information

First Posted
September 15, 2017
Last Updated
May 17, 2022
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT03286309
Brief Title
Soft Robotic Hand System for Stroke Rehabilitation
Official Title
Soft Robotic Hand System for Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMG-driven soft robot hand
Arm Type
Experimental
Arm Description
subjects will receive EMG-driven soft robot hand system.
Arm Title
sham group
Arm Type
Placebo Comparator
Arm Description
subjects will receive passive pre-programmed soft robot hand system.
Intervention Type
Device
Intervention Name(s)
soft robot hand system
Intervention Description
subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.
Primary Outcome Measure Information:
Title
Upper limb Fugl Meyer Assessment
Time Frame
3-month follow up
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Time Frame
3-month follow up
Title
Modified Ashworth Scale
Description
Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension
Time Frame
3-month follow up
Title
Box and Block Test
Time Frame
3-month follow up
Title
Max Voluntary Grip Force
Time Frame
3-month follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic); sufficient cognition to follow simple instructions as well as understand the content and purpose of the study; able to sit up for 45 minutes (with or without assistance). Exclusion criteria: Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication; any additional medical or psychological condition affecting their ability to comply with the study protocol; history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Kai-yu Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Kai-yu Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Soft Robotic Hand System for Stroke Rehabilitation

We'll reach out to this number within 24 hrs