NCT02393404

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

March 9, 2015

Last Update Submit

March 18, 2015

Conditions

Developmental Coordination Disorder

Outcome Measures

Primary Outcomes (2)

  • Changes in sensory organisation test balance strategy

    Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)

  • Changes in sensory organisation test composite scores

    Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)

Secondary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (3)

PT-FMT

EXPERIMENTAL

Functional movement-power training group

Other: PT-FMT

FMT alone

EXPERIMENTAL

Functional movement training group

Other: FMT alone

Control

NO INTERVENTION

No intervention control group

Interventions

PT-FMTOTHER

Physiotherapeutic functional movement-power training

PT-FMT
FMT aloneOTHER

Physiotherapeutic power training

FMT alone

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • years old
  • attending a mainstream school; and (5) no intellectual impairment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Pokfulam, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 27100457DERIVED

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Shirley SM Fong, PT, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 19, 2015

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

HK(1)