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Developmental Coordination DisorderNCT02393404

Functional Movement-power Training for Children With Developmental Coordination Disorder: A Randomised Controlled Trial

A study testing PT-FMT and FMT alone in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 10 years
Conditions the study is for
Developmental Coordination Disorder
What is being tested?
PT-FMT and FMT alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteHong Kong
Study dates
Mar 2014to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • University of Hong Kong

    Pokfulam

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
PT-FMT, FMT alone
Medical subject headings
Motor Skills Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PT-FMTOther

    Physiotherapeutic functional movement-power training

  • FMT aloneOther

    Physiotherapeutic power training

Study groups in NCT02393404
Study groupRoleWhat they receive
PT-FMTExperimentalFunctional movement-power training group
Receives: Other: PT-FMT
FMT aloneExperimentalFunctional movement training group
Receives: Other: FMT alone
ControlNo interventionNo intervention control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in sensory organisation test balance strategy

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

  2. Changes in sensory organisation test composite scores

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

Secondary outcomes (4)
  1. Changes in Movement Assessment Battery for Children total impairment score

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

  2. Changes in Movement Assessment Battery for Children balance subscore

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

  3. Changes in hand-held dynamometer measurements of lower limb muscle strength

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

  4. Changes in hand-held dynamometer measurements of lower limb muscle time to peak force

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393404
Sponsor's protocol ID
27100614
Status last verified
Mar 2015
First submitted
9 Mar 2015
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27100457

Questions about this trial

What is this clinical trial studying?

A study testing PT-FMT and FMT alone in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393404, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.

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