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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
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 8, 2018
Last Updated
July 11, 2019
Sponsor
Taipei Medical University Shuang Ho Hospital
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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
Citations:
PubMed Identifier
16108461
Citation
Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
Results Reference
background
PubMed Identifier
24958005
Citation
Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.
Results Reference
background
PubMed Identifier
18929198
Citation
Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032.
Results Reference
background
PubMed Identifier
24366991
Citation
Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
Results Reference
background
PubMed Identifier
25476507
Citation
Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N. Effects of contralesional robot-assisted hand training in patients with unilateral spatial neglect following stroke: a case series study. J Neuroeng Rehabil. 2014 Dec 5;11:160. doi: 10.1186/1743-0003-11-160.
Results Reference
background
Citation
Sgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015
Results Reference
background
PubMed Identifier
18936558
Citation
Fasoli SE, Fragala-Pinkham M, Hughes R, Hogan N, Krebs HI, Stein J. Upper limb robotic therapy for children with hemiplegia. Am J Phys Med Rehabil. 2008 Nov;87(11):929-36. doi: 10.1097/PHM.0b013e31818a6aa4.
Results Reference
background
Citation
Ming-Juei Chang (2017).Prevalence, healthcare and rehabilitation services utilization in individuals with cerebral palsy.Taiwan Master Master's Thesis
Results Reference
background
Citation
Levitt, S. (2013). Treatment of cerebral palsy and motor delay. John Wiley & Sons.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
1463061
Citation
McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
Results Reference
background
PubMed Identifier
16915877
Citation
Asher AV. Handwriting instruction in elementary schools. Am J Occup Ther. 2006 Jul-Aug;60(4):461-71. doi: 10.5014/ajot.60.4.461.
Results Reference
background
Citation
Henderson, A., & Pehoski, C. (Eds.). (2006). Hand function in the child: Foundations for remediation. Elsevier Health Sciences.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
24681826
Citation
Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
Results Reference
background
PubMed Identifier
24232363
Citation
Lohse K, Shirzad N, Verster A, Hodges N, Van der Loos HF. Video games and rehabilitation: using design principles to enhance engagement in physical therapy. J Neurol Phys Ther. 2013 Dec;37(4):166-75. doi: 10.1097/NPT.0000000000000017.
Results Reference
background
PubMed Identifier
21651800
Citation
Pichierri G, Wolf P, Murer K, de Bruin ED. Cognitive and cognitive-motor interventions affecting physical functioning: a systematic review. BMC Geriatr. 2011 Jun 8;11:29. doi: 10.1186/1471-2318-11-29.
Results Reference
background
PubMed Identifier
23030054
Citation
Winkels DG, Kottink AI, Temmink RA, Nijlant JM, Buurke JH. Wii-habilitation of upper extremity function in children with cerebral palsy. An explorative study. Dev Neurorehabil. 2013;16(1):44-51. doi: 10.3109/17518423.2012.713401. Epub 2012 Oct 3.
Results Reference
background
PubMed Identifier
27134357
Citation
Acar G, Altun GP, Yurdalan S, Polat MG. Efficacy of neurodevelopmental treatment combined with the Nintendo((R)) Wii in patients with cerebral palsy. J Phys Ther Sci. 2016 Mar;28(3):774-80. doi: 10.1589/jpts.28.774. Epub 2016 Mar 31.
Results Reference
background
PubMed Identifier
15324721
Citation
Dobkin BH. Strategies for stroke rehabilitation. Lancet Neurol. 2004 Sep;3(9):528-36. doi: 10.1016/S1474-4422(04)00851-8.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18184932
Citation
Volpe BT, Lynch D, Rykman-Berland A, Ferraro M, Galgano M, Hogan N, Krebs HI. Intensive sensorimotor arm training mediated by therapist or robot improves hemiparesis in patients with chronic stroke. Neurorehabil Neural Repair. 2008 May-Jun;22(3):305-10. doi: 10.1177/1545968307311102. Epub 2008 Jan 9.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
27056250
Citation
Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.
Results Reference
background
Citation
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.
Results Reference
background

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

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