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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02393404
Other study ID # 27100614
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 9, 2015
Last updated March 18, 2015
Start date March 2014
Est. completion date March 2017

Study information

Verified date March 2015
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 87
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria:

1. a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)

2. a gross motor composite score = 42 on the Bruininks-Oseretsky Test of Motor Proficiency

3. 6-10 years old

4. attending a mainstream school; and (5) no intellectual impairment.

Exclusion Criteria:

1. diagnosis of an emotional, neurological or other movement disorder

2. significant congenital, musculoskeletal or cardiopulmonary disorders that might affect motor performance

3. receiving active treatments including traditional Chinese medicine

4. disruptive behaviour

5. unable to follow instructions thoroughly.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
PT-FMT
Physiotherapeutic functional movement-power training
FMT alone
Physiotherapeutic power training

Locations

Country Name City State
Hong Kong University of Hong Kong Pokfulam

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in sensory organisation test balance strategy Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months) No
Primary Changes in sensory organisation test composite scores Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months) No
Secondary Changes in Movement Assessment Battery for Children total impairment score Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months) No
Secondary Changes in Movement Assessment Battery for Children balance subscore Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months) No
Secondary Changes in hand-held dynamometer measurements of lower limb muscle strength Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months) No
Secondary Changes in hand-held dynamometer measurements of lower limb muscle time to peak force Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months) No
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