Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia

May 3, 2023 updated by: Zhenlan li, The First Hospital of Jilin University
Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. The force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Changchun, China
        • Recruiting
        • First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • First-ever stroke
  • Aged 20~80 years old
  • Post-stroke time≤6 months
  • Clinically diagnosed with a central paresis of the right arm/hand (Brunnstrom stage of the affected upper limb≥II, Brunnstrom stage of the affected hand II~V, Active flexion range of motion of the affected finger joint≥10°, MAS of affected upper limb and finger≤1+
  • Sitting balance≥Level 2
  • No serious depression and no visual impairment
  • Cognitive and speech abilities sufficient to understand instructions and to provide informed consent

Exclusion Criteria:

  • Severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance
  • Sensory disturbance of fingers
  • Severe joint pain caused by various reasons affects the functional activities of fingers
  • Complicated with serious heart, lung, liver, kidney or infection
  • Attending another study or therapy to improve arm-hand function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Device: force feedback rehabilitation robot (SEM™ Glove)
In the experimental group, the therapists were asked to illustrate and demonstrate the motor points of the cylindrical grasping and spherical grasping movements, and the patients were instructed to imitate them with nonparalytic hand, while the latter patients wore SEM™ Glove were used for task-oriented training, such as inserting pegs, grasping a ball into a barrel, and drinking water exercises. The difficulty of task-oriented training can be adjusted according to the patient's actual condition, such as changing the shape, weight, size of the target or changing the distance, duration, and so on during training
Other Names:
  • SEM™ Glove
Active Comparator: control group
Other: assisted by a therapist
The control group received task-oriented training assisted by a therapist to complete the same task as the experimental group. Therapists need to instruct patients to try to grasp items and give appropriate assistance to guarantee their completion of the grasping task. If finger extension is weak, the therapist assists the patient in extension of the digits before grasping the items, and if the finger flexion angle does not meet the grasp function needs, it should assist in flexion finger movements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer motor function assessment-upper limb finger motor part
Time Frame: Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks
Fugl-meyer motor function assessment-upper limb (FMA-UL) has been found a reliable and valid test for the assessment of arm hand function in stroke patients. The maximum score of on the FMA-UL is 66 points. This study used FMA-UL finger motor part , with a total score of 14 points.
Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth scale (MAS)
Time Frame: Change from baseline Modified Ashworth scale outcome at 4 weeks
The Modified Ashworth scale (MAS) was used to rate muscle tone/stiffness during passive movement of the flexors of the fingers. The scale ranges from '0 = normal','1','1+','2','3', and '4= worst'. Participants were assessed in all sessions using this 6-point ordinal scale for the hand treated in the study
Change from baseline Modified Ashworth scale outcome at 4 weeks
Range of motion (ROM)
Time Frame: Change from baseline range of motion outcome at 4 weeks
Range of motion (ROM) was measured with a goniometer. This study measures ROM of each finger, sum of five fingers flexion ROM, sum of five fingers extension ROM and total ROM of the five fingers. The ROM of each finger is the difference between the total ROM of each finger joint in the extension position and the total ROM of each finger joint in the flexion position. The sum of five finger flexion ROM is the sum of 14 finger joint flexion ROM. The sum of five finger extension ROM is the sum of 14 finger joint extension ROM. The total ROM of the five fingers is the difference between the total ROM of the extension position and the total ROM of the flexion position. The goniometer is used to measure the AROM of the affected hand first, and then the PROM.
Change from baseline range of motion outcome at 4 weeks
grip strength
Time Frame: Change from baseline grip strength at 4 weeks
Grip strength of the dominant hand was tested using an isometric hand dynamometer in the testing position recommended by American Society of Hand Therapists(ASHT). Participants gripped the dynamometer as hard as possible once without any jerking. The best score out of three consecutive trials was used for analyses. Sufficient time was allowed for the participants to recover from any fatigue related to grip testing
Change from baseline grip strength at 4 weeks
Brunnstrom recovery stages of hand (BRS-H)
Time Frame: Change from baseline brunnstrom recovery stages of hand at 4 weeks
Brunnstrom recovery stages of hand (BRS-H) classifies the motor function into 6 levels based on recovery stages from a flaccid limb to near-normal and normal movement and coordination. Higher levels indicate better motor function. This study, the I-VI levels of the motor function were assigned with a score from 1 to 6.
Change from baseline brunnstrom recovery stages of hand at 4 weeks
Barthel index (BI)
Time Frame: Change from baseline barthel index at 4 weeks
Barthel index contains 10 items and has a score range from 0 to 100, was used to assess activity and participation
Change from baseline barthel index at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Anticipated)

November 10, 2023

Study Completion (Anticipated)

November 10, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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