Functional Movement-power Training for Children With Developmental Coordination Disorder: A Randomised Controlled Trial
Primary Purpose
Developmental Coordination Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
PT-FMT
FMT alone
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Coordination Disorder
Eligibility Criteria
Inclusion Criteria:
- a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- a gross motor composite score ≤ 42 on the Bruininks-Oseretsky Test of Motor Proficiency
- 6-10 years old
- attending a mainstream school; and (5) no intellectual impairment.
Exclusion Criteria:
- diagnosis of an emotional, neurological or other movement disorder
- significant congenital, musculoskeletal or cardiopulmonary disorders that might affect motor performance
- receiving active treatments including traditional Chinese medicine
- disruptive behaviour
- unable to follow instructions thoroughly.
Sites / Locations
- University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
PT-FMT
FMT alone
Control
Arm Description
Functional movement-power training group
Functional movement training group
No intervention control group
Outcomes
Primary Outcome Measures
Changes in sensory organisation test balance strategy
Changes in sensory organisation test composite scores
Secondary Outcome Measures
Changes in Movement Assessment Battery for Children total impairment score
Changes in Movement Assessment Battery for Children balance subscore
Changes in hand-held dynamometer measurements of lower limb muscle strength
Changes in hand-held dynamometer measurements of lower limb muscle time to peak force
Full Information
NCT ID
NCT02393404
First Posted
March 9, 2015
Last Updated
March 18, 2015
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02393404
Brief Title
Functional Movement-power Training for Children With Developmental Coordination Disorder: A Randomised Controlled Trial
Official Title
Enhancing Neuromuscular Performance and Central Nervous System Plasticity Through Functional Movement-power Training to Improve Balance Strategies in Children With Developmental Coordination Disorder: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective: To compare the effectiveness of functional movement-power training (PT-FMT), functional movement training (FMT) alone and no intervention in improving balance strategies and performance among children with developmental coordination disorder (DCD).
Design: A randomised controlled clinical trial. Sample: 87 children with DCD. Interventions: 12 weeks of PT and FMT or FMT alone in the two intervention groups.
Major outcomes: Sensory organisation test - balance strategy and composite scores; Movement Assessment Battery for Children - total impairment score and balance subscore; hand-held dynamometer measurements of lower limb muscle strength and time to peak force.
Detailed Description
With the growing numbers of children with dyspraxia in Hong Kong, the focus of paediatric rehabilitation services has shifted from severe motor disorders (e.g., cerebral palsy) to relatively minor motor problems such as developmental coordination disorder (DCD). Evidence-based treatment strategies must be developed to suit this changing need. Children diagnosed with DCD are characterised by marked impairment in motor functions. Poor balance ability is a major concern because it may predispose children to falls and affect their motor skill development. At present, rehabilitation regimes for DCD-affected children use functional movement training (FMT) to induce neural plastic changes in the central nervous system (CNS) and thus enhance functional (balance) performance. Less emphasis is placed on treating the neuromuscular impairments that might also affect functional outcomes. Recently, the investigators research team discovered that slowed hamstring muscle force production, a neuromuscular deficit, may be one of the causes of poor balance strategies in children with DCD, but no effective treatment strategy has yet been examined. Power training (PT) has been found to be effective in increasing the speed of muscle force production and balance in adults through various neuromuscular mechanisms. In this study, the investigators intend to treat both the CNS and peripheral neuromuscular deficits in DCD-affected children. Therefore, the investigators will incorporate PT into a conventional FMT regime. The investigators hypothesise that balance strategies and functional performance in children with DCD will be improved most by treating both the CNS and neuromuscular deficits. This hypothesis will be supported by the finding that PT with FMT is superior to FMT alone in improving balance strategies and functional performance in children with DCD.
Objective: To compare the effectiveness of PT-FMT, FMT alone and no intervention in improving balance strategies and performance among children with DCD. Design: A randomised controlled clinical trial. Sample: 87 children with DCD. Interventions: 12 weeks of PT and FMT or FMT alone in the two intervention groups.
Major outcomes: Sensory organisation test - balance strategy and composite scores; Movement Assessment Battery for Children - total impairment score and balance subscore; hand-held dynamometer measurements of lower limb muscle strength and time to peak force.
Anticipated results and clinical significance: DCD-affected children who receive FMT together with PT will have the best balance performance outcomes. If the results are positive, this training programme could be readily transferrable to clinical practice. This could have positive socio-economic implications, such as shorter treatment periods and reduced healthcare costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PT-FMT
Arm Type
Experimental
Arm Description
Functional movement-power training group
Arm Title
FMT alone
Arm Type
Experimental
Arm Description
Functional movement training group
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention control group
Intervention Type
Other
Intervention Name(s)
PT-FMT
Intervention Description
Physiotherapeutic functional movement-power training
Intervention Type
Other
Intervention Name(s)
FMT alone
Intervention Description
Physiotherapeutic power training
Primary Outcome Measure Information:
Title
Changes in sensory organisation test balance strategy
Time Frame
Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
Title
Changes in sensory organisation test composite scores
Time Frame
Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
Secondary Outcome Measure Information:
Title
Changes in Movement Assessment Battery for Children total impairment score
Time Frame
Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
Title
Changes in Movement Assessment Battery for Children balance subscore
Time Frame
Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
Title
Changes in hand-held dynamometer measurements of lower limb muscle strength
Time Frame
Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
Title
Changes in hand-held dynamometer measurements of lower limb muscle time to peak force
Time Frame
Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
a gross motor composite score ≤ 42 on the Bruininks-Oseretsky Test of Motor Proficiency
6-10 years old
attending a mainstream school; and (5) no intellectual impairment.
Exclusion Criteria:
diagnosis of an emotional, neurological or other movement disorder
significant congenital, musculoskeletal or cardiopulmonary disorders that might affect motor performance
receiving active treatments including traditional Chinese medicine
disruptive behaviour
unable to follow instructions thoroughly.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley SM Fong, PT, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Pokfulam
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
27100457
Citation
Fong SSM, Guo X, Cheng YTY, Liu KPY, Tsang WWN, Yam TTT, Chung LMY, Macfarlane DJ. A Novel Balance Training Program for Children With Developmental Coordination Disorder: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Apr;95(16):e3492. doi: 10.1097/MD.0000000000003492.
Results Reference
derived
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Functional Movement-power Training for Children With Developmental Coordination Disorder: A Randomised Controlled Trial
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