NCT04330417

Brief Summary

Stroke patients have limited hand mobility post-stroke, thus inhibiting them from performing daily functional tasks independently, resulting in reduced quality of life. Current hand rehabilitation robotic devices are typically driven by rigid linkages/joints, which subject the fingers into a single plane of motion that is unnatural and uncomfortable. These devices belong to the class of continuous passive motion (CPM) devices that only promote hand range-of-motion, but do not require the patient to play an active role in performing the hand exercises. There is a strong need for a device that can resolve the lack of compliant robot-assisted hand motion and lack of intuitive user control in assistive and rehabilitation processes. This proposed research aims to fill the above-mentioned gaps for current hand rehabilitation devices by developing a soft robotic glove that provides compliant assistance to bidirectional hand motion, coupled with intuitive user control. In the short term, the robotic glove will likely enhance the patients' hand flexion-extension range of motion and improve the neuro-motor control of the hand. In the long term, the robotic glove will act as an adjunct to therapists, thereby raising productivity in the presence of growing manpower constraints and optimizing therapy time for the patients; this can potentially enhance recovery time and quality of life, as a result of improved hand mobility for common daily tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

April 24, 2019

Last Update Submit

March 3, 2022

Conditions

Stroke

Keywords

StrokeSoft Robotic GloveElectromyographyHand Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Functional Assessment

    Fugl-Meyer Assessment (FMA) Upper Extremity (UE) Score, A total of 66 scores.

    Change from Baseline FMA score at 6 weeks.

  • Functional Assessment

    Action Research Arm Test (ARAT), A total of 57 scores.

    Change from Baseline ARAT score at 6 weeks.

  • Brain Imaging

    Functional Magnetic Resonance Imaging

    Change from Baseline Imaging at 6 weeks.

Study Arms (2)

EMG Glove Group

EXPERIMENTAL

A total of 12 sessions of robot-assisted hand training for 6 consecutive weeks.

Device: Robot-Assisted Hand Training

Control Group

ACTIVE COMPARATOR

A total of 12 session of standard hand therapy sessions in 6 consecutive weeks.

Other: Standard Hand Therapy

Interventions

Robot-Assisted Hand TrainingDEVICE

Perform activities of daily living, e.g., write sentences, turn cards, move small and big objects, simulated feeding, stack checkers, pour water, squeeze handles

EMG Glove Group
Standard Hand TherapyOTHER

Stretching, Strengthening, Hand Functional Training

Control Group

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 30-90 years regardless of lesion size, race
  • Stroke type: ischemic or haemorrhagic
  • Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of a maximum score of 66 on the Fugl-Meyer assessment scale
  • Able to comprehend and follow commands
  • Unilateral upper limb impairment

You may not qualify if:

  • Recurrent stroke
  • Unstable medical conditions or anticipated life expectancy of \<1 year
  • History of severe depression or active psychiatric disorder
  • Severe spasticity (Modified Ashworth scale \>2)
  • Poor skin condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (2)

  • Yap HK, Lim JH, Nasrallah F, Yeow CH. Design and Preliminary Feasibility Study of a Soft Robotic Glove for Hand Function Assistance in Stroke Survivors. Front Neurosci. 2017 Oct 9;11:547. doi: 10.3389/fnins.2017.00547. eCollection 2017.

    PMID: 29062267BACKGROUND

  • Koh TH, Cheng N, Yap HK, Yeow CH. Design of a Soft Robotic Elbow Sleeve with Passive and Intent-Controlled Actuation. Front Neurosci. 2017 Oct 25;11:597. doi: 10.3389/fnins.2017.00597. eCollection 2017.

    PMID: 29118693BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 1, 2020

Study Start

October 13, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 4, 2022

Record last verified: 2022-03

Locations

SG(1)