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

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ClinicalTrials.gov Identifier: NCT03490591
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: Robot-assisted hand rehabilitation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects on Hand Function With Robot-assisted Rehabilitation for Children With Cerebral Palsy: a Pilot Study
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Robotic-assisted intervention
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Box and block test [ Time Frame: Change 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.

  2. EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi [ Time Frame: Change 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.

  3. Jamar Handgrip Dynamometer [ Time Frame: Change 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.

  4. ABILHAND-Kids questionnaire [ Time Frame: Change 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490591


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Study Chair: Jui chi Lin, master Taipei Medical University, Taiwan, R.O.C.
More Information
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Publications:
Sgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015
Ming-Juei Chang (2017).Prevalence, healthcare and rehabilitation services utilization in individuals with cerebral palsy.Taiwan Master Master's Thesis
Levitt, S. (2013). Treatment of cerebral palsy and motor delay. John Wiley & Sons.
Ching-Yi Chen,Ching-Chun Li,Jiunn-Horng Kang(2013). Medical Utilization among Patients with Cerebral Palsy, Taiwan Journal of Physical Medicine and Rehabilitation41(4), 225-234.
Henderson, A., & Pehoski, C. (Eds.). (2006). Hand function in the child: Foundations for remediation. Elsevier Health Sciences.
Hsieh-Chun Hsieh(2010). Effects of Parent-Child Toy-Playing Activities on the Motor Development of Children with Cerebral Palsy. Ulletin of special education, 35(2), 81-101.
Huang, C. W. (2016). Effectiveness of unilateral versus bilateral intensive training in children with cerebral palsy: a randomized controlled study. Taiwan University Occupational Therapy Research Institute Thesis, 1-82.
Buerger, S. P., & Hogan, N. (2006, October). Relaxing passivity for human-robot interaction. In Intelligent Robots and Systems, 2006 IEEE/RSJ International Conference on (pp. 4570-4575). IEEE.
Pětioký, J. Robot-assisted therapy integrated with virtual reality for rehabilitation of hand function after stroke: a clinical case study. in the 20th ESPRM Congress 2016.
Lincoln, N. B., Jackson, J. M., & Adams, S. A. (1998). Reliability and revision of the Nottingham Sensory Assessment for stroke patients. Physiotherapy, 84(8), 358-365.

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Responsible Party: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03490591    
Other Study ID Numbers: TMU-JIRB N201711070
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University Shuang Ho Hospital:
Cerebral Palsy
Robotic rehabilitation
Hand function
Activities of Daily Living
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases