Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study

July 11, 2019 updated by: Taipei Medical University Shuang Ho Hospital

The Effects on Hand Function With Robot-assisted Rehabilitation for Children With Cerebral Palsy: a Pilot Study

Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).

Materials and Methods: Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), Grasp strength, & ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hand function is the most important for ADL and learning ability. Many cerebral palsy(CP) suffered problems with the gross motor dysfunction and hand function disability. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg, school). Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility for cerebral palsy(CP).

Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).

Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), grasp strength, & ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.

Study Type

Interventional

Enrollment (Actual)

8

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 Locations

  • Taiwan
      • Taipei, Taiwan
        • Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University

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

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with cerebral palsy(CP) or stroke
  • Age younger than 18 and older than 6 years old
  • Could follow 2 step order instruction
  • No Botulinum injection during the recent 6 month and the experiment period
  • Chronicity > 1 years and stable medicine condition
  • Could sit steady after the position

Exclusion Criteria:

  • Individuals with other medical symptoms that can affect movement
  • Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic-assisted intervention
In the Robotic-assisted intervention :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
Behavioral: Robot-assisted hand rehabilitation
Robot-assisted hand rehabilitation: 20 minute of warm-up exercise and 40 minute of robot-assisted hand exercise intervention. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task, robot-assisted task, and game task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment:Upper Limb section
Time Frame: Change from baseline to 6 weeks, follow up at one month
The Fugl-Meyer motor assessments for the upper limb section(scores from 0 to 66 points)that evaluates reflexes, volitional movements and rapid alternating movements. The higher values represent a better outcome.
Change from baseline to 6 weeks, follow up at one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and block test
Time Frame: Change from baseline to 6 weeks, follow up at one month
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity.
Change from baseline to 6 weeks, follow up at one month
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi
Time Frame: Change from baseline to 6 weeks, follow up at one month
Surface electromyography root mean square from brachioradialis and extensor carpi was normalized to the maximal voluntary contraction recording. The higher muscle activation during the task indicate the more efficacy to grasp or release the block.
Change from baseline to 6 weeks, follow up at one month
Jamar Handgrip Dynamometer
Time Frame: Change from baseline to 6 weeks, follow up at one month
The Jamar hydraulic handgrip dynamometer for measuring the maximum isometric strength of the hand and forearm muscles. The mean score among three trials of each instrument was recorded for data calculations. The higher scores presents the better hand grip strength.
Change from baseline to 6 weeks, follow up at one month
ABILHAND-Kids questionnaire
Time Frame: Change from baseline to 6 weeks, follow up at one month
A measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved. The parent is asked to rate his/her perception on the response scale as "Impossible", "Difficult" or "Easy" (0 = "Impossible", 1 = "Difficult" or 2 = "Easy"). The activities not attempted by the child within the last 3 months are not scored and are entered as not applicable. The total score based on 21 activities is then converted into a linear measure of manual ability (logits). This test was specifically developed for children with CP using the Rasch measurement model and showed a good reliability and reproducibility over time.
Change from baseline to 6 weeks, follow up at one month

Collaborators and Investigators

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

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Chair: Jui chi Lin, master, Taipei Medical University, Taiwan, R.O.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-JIRB N201711070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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