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.
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.
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.
- Conditions
- Developmental Coordination Disorder
- 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 group | Role | What they receive |
|---|---|---|
| PT-FMT | Experimental | Functional movement-power training group Receives: Other: PT-FMT |
| FMT alone | Experimental | Functional movement training group Receives: Other: FMT alone |
| Control | No intervention | No intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sensory organisation test balance strategy
Measured: Baseline (0 month), 3-month post-intervention (3 months), and 3-month follow-up (6 months)
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)
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)
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)
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)
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.
- First posted19 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley S.M. Fong, The University of Hong Kong
- Investigators
- Shirley SM Fong, PT, PhD, Principal investigator, The University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02393404
- Acronym / sponsor ID
- 27100614
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PT-FMT | Experimental | Other: PT-FMTFunctional movement-power training group |
| FMT alone | Experimental | Other: FMT aloneFunctional movement training group |
| Control | No intervention | –No intervention control group |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT-FMTPhysiotherapeutic functional movement-power training | Other | PT-FMT |
| FMT alonePhysiotherapeutic power training | Other | FMT alone |
Primary outcome
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)
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)
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Derived from this study: PubMed 27100457Fong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley SM Fong, PT, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
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.