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

Not Applicable
Completed
Conditions
Cerebral Palsy
Interventions
Behavioral: Robot-assisted hand rehabilitation
Registration Number
NCT03490591
Lead Sponsor
Taipei Medical University Shuang Ho Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
8
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Robotic-assisted interventionRobot-assisted hand rehabilitationIn the Robotic-assisted intervention :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
Primary Outcome Measures
NameTimeMethod
Fugl-Meyer Assessment:Upper Limb sectionChange 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 Outcome Measures
NameTimeMethod
Box and block testChange 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.

Jamar Handgrip DynamometerChange 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.

ABILHAND-Kids questionnaireChange 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.

EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpiChange 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.

Trial Locations

Locations (1)

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

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Taipei, Taiwan

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