Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Robot-assisted hand rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Robotic rehabilitation, Hand function, Activities of Daily Living
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
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic-assisted intervention
Arm Description
In the Robotic-assisted intervention :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Box and block test
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.
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi
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.
Jamar Handgrip Dynamometer
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 questionnaire
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.
Full Information
NCT ID
NCT03490591
First Posted
February 8, 2018
Last Updated
July 11, 2019
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03490591
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Robotic rehabilitation, Hand function, Activities of Daily Living
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic-assisted intervention
Arm Type
Experimental
Arm Description
In the Robotic-assisted intervention :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
Intervention Type
Behavioral
Intervention Name(s)
Robot-assisted hand rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment:Upper Limb section
Description
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.
Time Frame
Change from baseline to 6 weeks, follow up at one month
Secondary Outcome Measure Information:
Title
Box and block test
Description
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.
Time Frame
Change from baseline to 6 weeks, follow up at one month
Title
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi
Description
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.
Time Frame
Change from baseline to 6 weeks, follow up at one month
Title
Jamar Handgrip Dynamometer
Description
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.
Time Frame
Change from baseline to 6 weeks, follow up at one month
Title
ABILHAND-Kids questionnaire
Description
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.
Time Frame
Change from baseline to 6 weeks, follow up at one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jui chi Lin, master
Organizational Affiliation
Taipei Medical University, Taiwan, R.O.C.
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study
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