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Clinical Trials/NCT03490591
NCT03490591
Completed
Not Applicable

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

Taipei Medical University Shuang Ho Hospital1 site in 1 country8 target enrollmentApril 15, 2018
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
8
Locations
1
Primary Endpoint
Fugl-Meyer Assessment:Upper Limb section
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2018
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Box and block test(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)
  • EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi(Change from baseline to 6 weeks, follow up at one month)

Study Sites (1)

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