Soft Robotic Hand System for Stroke Rehabilitation
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Apr 2018
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedStudy Start
First participant enrolled
April 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 23, 2022
May 1, 2022
4.2 years
September 15, 2017
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Upper limb Fugl Meyer Assessment
3-month follow up
Secondary Outcomes (4)
Action Research Arm Test
3-month follow up
Modified Ashworth Scale
3-month follow up
Box and Block Test
3-month follow up
Max Voluntary Grip Force
3-month follow up
Study Arms (2)
EMG-driven soft robot hand
EXPERIMENTALsubjects will receive EMG-driven soft robot hand system.
sham group
PLACEBO COMPARATORsubjects will receive passive pre-programmed soft robot hand system.
Interventions
subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biomedical Engineering, The Chinese University of Hong Kong
Shatin, Hong Kong
Related Publications (1)
Shi XQ, Ti CE, Lu HY, Hu CP, Xie DS, Yuan K, Heung HL, Leung TW, Li Z, Tong RK. Task-Oriented Training by a Personalized Electromyography-Driven Soft Robotic Hand in Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2024 Aug;38(8):595-606. doi: 10.1177/15459683241257519. Epub 2024 May 29.
PMID: 38812378DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Kai-yu Tong, PhD
Department of Biomedical Engineering, CUHK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 18, 2017
Study Start
April 12, 2018
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
May 23, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share