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Status unknownNCT03286309Updated May 23, 2022

Soft Robotic Hand System for Stroke Rehabilitation

An interventional study of soft robot hand system in Stroke, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    EMG-driven soft robot hand

    subjects will receive EMG-driven soft robot hand system.

    Device: soft robot hand system

  • Placebo comparator
    sham group

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

    Device: soft robot hand system

Interventions

  • Devicesoft robot hand system

    subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

05

What researchers measure

Primary outcomes

  1. Upper limb Fugl Meyer Assessment

    Time frame: 3-month follow up

Secondary outcomes

  1. Action Research Arm Test

    Time frame: 3-month follow up

  2. Modified Ashworth Scale

    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

  3. Box and Block Test

    Time frame: 3-month follow up

  4. Max Voluntary Grip Force

    Time frame: 3-month follow up

06

Study locations

1 of 1 sites recruiting
  • Department of Biomedical Engineering, The Chinese University of Hong Kong
    Shatin, Hong Kong
    • Raymond Tong, PhD · Contact · +852 3943 8454
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03286309
Lead sponsor
Chinese University of Hong Kong
Responsible party
Raymond KY Tong (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 18, 2017
Start date
Apr 12, 2018
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
May 23, 2022

Study contacts

Raymond Kai-yu Tong, PhD
Contact
kytong@cuhk.edu.hk
+852 3943 8454
Raymond Kai-yu Tong, PhD
principal investigator · Department of Biomedical Engineering, CUHK

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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