NCT06062121

Brief Summary

The research purpose is to investigate the feasibility of using a motor-cable-driven system for wrist and forearm recovery of hemiplegic subjects suffered from stroke, where assistive force would be generated from cables connected to pulleys and electrical motors. The system may use EMG signal to control the movements.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

August 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 31, 2023

Last Update Submit

September 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Forearm's Assisted Range of Motion

    Forearm's assisted range of motion is a measurement to identify how far the person's joints range can move in pronation-supination assisted by the motor-cable-driven system. The moving range will be recorded by the system and stored in computer

    Baseline

  • Wrist's Assisted Range of Motion

    Wrist's Assisted range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation with the assistance of motor-cable-driven system. The moving range will be recorded by the system and stored in computer.

    Baseline

Secondary Outcomes (7)

  • Upper limb Fugl-Meyer Assessment (FMA)

    Baseline

  • Motor Assessment Scale (MAS)

    Baseline

  • Modified Ashworth Scale

    Baseline

  • Forearm's Active Range of Movement

    Baseline

  • Forearm's Passive Range of Motion

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

motor-cable-driven system

EXPERIMENTAL

Receive motor-cable-driven system

Device: Motor-cable-driven Rehabilitation Robotic System

Interventions

Subjects will wear the motor-cable-driven system and receive 30 minutes (including preparation time) wrist and forearm robot-assisting exercise

motor-cable-driven system

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sub-acute and chronic stroke patients (ischemic or hemorrhagic).
  • Sufficient cognition to follow simple instructions as well as understand the content and purpose of the study.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Kai-yu Tong

    Department of Biomedical Engineering, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Kai-yu Tong

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2023

First Posted

October 2, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

October 2, 2023

Record last verified: 2023-09

Locations