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

NCT03490591 | Completed

• 1 other identifier: TMU-JIRB N201711070
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Robotic rehabilitation; Hand function; Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment:Upper Limb section

  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 Outcomes (4)

• Box and block test

  Change from baseline to 6 weeks, follow up at one month

• EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi

  Change from baseline to 6 weeks, follow up at one month

• Jamar Handgrip Dynamometer

  Change from baseline to 6 weeks, follow up at one month

• ABILHAND-Kids questionnaire

  Change from baseline to 6 weeks, follow up at one month

Study Arms (1)

Robotic-assisted intervention

EXPERIMENTAL

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

Interventions

Robot-assisted hand rehabilitation BEHAVIORAL

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.

Robotic-assisted intervention

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

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

Taipei, Taiwan

Location

Related Publications (26)

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  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jui chi Lin, master

  Taipei Medical University, Taiwan, R.O.C.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: April 6, 2018
• Study Start: April 15, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 12, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)