Clinical trial NCT03490591: Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study
Official title: The Effects on Hand Function With Robot-assisted Rehabilitation for Children With Cerebral Palsy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Robotic rehabilitation
Hand function
Activities of Daily Living
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl-Meyer Assessment:Upper Limb section
timeFrame: Change from baseline to 6 weeks, follow up at one month
Secondary outcomes:
measure: Box and block test
timeFrame: Change from baseline to 6 weeks, follow up at one month
measure: EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi
timeFrame: Change from baseline to 6 weeks, follow up at one month
measure: Jamar Handgrip Dynamometer
timeFrame: Change from baseline to 6 weeks, follow up at one month
measure: ABILHAND-Kids questionnaire
timeFrame: Change from baseline to 6 weeks, follow up at one month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Jui chi Lin, master
role: STUDY_CHAIR
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