Developmental Coordination DisorderNCT04123912
Kinesio Taping and Physiotherapeutic Exercises for Children With DCD
A study testing Kinesio Taping - Functional Movement Power Training in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Aim: To investigate the effectiveness of a novel elastic taping-augmented functional movement power training (KT-FMPT) program in improving leg muscular performance, body balance, motor proficiency and functional independence in children with developmental coordination disorder (DCD). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Kinesio Taping - Functional Movement Power Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6- to 12-years-old
- classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V
- score < 5th percentile on the Movement Assessment Battery for Children, 2nd edition (MABC-2)
- total score < 46 on the DCD questionnaire (2007)
- attending a mainstream primary school with intelligence level within the normal range
- no KT or FMPT experience
Who cannot join
- any known congenital, cognitive, psychiatric, neurological, sensorimotor, musculoskeletal or cardiopulmonary disorder that may affect test performance
- receiving active rehabilitation treatment
- demonstrating excessive disruptive behaviour
- unable to follow instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesio Taping and Functional Movement Power Training on Neuromuscular Performance, Motor Proficiency and Functional Independence in Children With Developmental Coordination Disorder: A Randomised Controlled Trial
Aim: To investigate the effectiveness of a novel elastic taping-augmented functional movement power training (KT-FMPT) program in improving leg muscular performance, body balance, motor proficiency and functional independence in children with developmental coordination disorder (DCD).
Methodology: In this clinical trial, twenty children with DCD (aged 6-12) will be randomly assigned to either a KT-FMPT group or a placebo control group. Children in the KT-FMPT and control groups will receive elastic taping-augmented FMPT and general jogging exercise with non-elastic taping, respectively, for 12 weeks (2 hours/week). Major outcome measures: body balance and leg muscle activity will be measured via muscle sensors along with a force platform. Secondary outcome measures: leg muscle strength, motor proficiency and functional independence will be assessed by a digital dynamometer, the Movement Assessment Battery for Children-2 and Pediatric Evaluation of Disability Inventory, respectively (before- and after-intervention measurements).
Significance: The KT-FMPT group is predicted to display much better muscular and motor performances than the control group. This novel training program can be readily adopted in clinical, school, or home settings to improve functional independence in children with DCD, an outcome with positive socioeconomic implications. Moreover, study findings will inspire future research work in children with other childhood-onset disabilities.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Kinesio Taping - Functional Movement Power Training, Jogging with placebo taping
- 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.
Kinesio Taping - Functional Movement Power TrainingBehavioural
Subjects assigned to the Kinesio Taping - Functional Movement Power Training (KT-FMPT) group will receive FMPT concurrent with KT. The FMPT protocol was developed by the research team with reference to common physiotherapeutic exercises for children with motor disabilities.9 It comprises 5 functional movement exercises and 6 lower-limb power/resistance training exercises using weights or resistance bands.
Jogging with placebo tapingBehavioural
Subjects assigned to the control group will receive no FMPT or KT, but participate in a jogging intervention with placebo tape applied on their calf muscles and removed after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| KT-FMPT group | Experimental | Not described Receives: Behavioral: Kinesio Taping - Functional Movement Power Training |
| Control group | Placebo comparator | Not described Receives: Behavioral: Jogging with placebo taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leg muscle electromyographic activation onset latency time (in ms)
Electromyographic activation onset of leg muscles
Measured: 0 and 3 months
Change in centre of pressure movement pathway in standing (in mm/cm)
Centre of pressure movement pathway in standing
Measured: 0 and 3 months
Secondary outcomes (3)
Change in lower-extremity maximum isometric muscle strength (in kg/N)
Maximum isometric leg muscle strength
Measured: 0 and 3 months
Change in Movement Assessment Battery for Children-2 percentile score
Movement Assessment Battery for Children-2 percentile (motor proficiency)
Measured: 0 and 3 months
Change in Pediatric Evaluation of Disability Inventory score
Pediatric Evaluation of Disability Inventory score (functional independence)
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123912
- Sponsor's protocol ID
- 0001
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Taping and Functional Movement Power Training on Neuromuscular Performance, Motor Proficiency and Functional Independence in Children With Developmental Coordination Disorder: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04123912
- Acronym / sponsor ID
- 0001
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Oct 2019 (actual)
- 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.
Aim: To investigate the effectiveness of a novel elastic taping-augmented functional movement power training (KT-FMPT) program in improving leg muscular performance, body balance, motor proficiency and functional independence in children with developmental coordination disorder (DCD).
Methodology: In this clinical trial, twenty children with DCD (aged 6-12) will be randomly assigned to either a KT-FMPT group or a placebo control group. Children in the KT-FMPT and control groups will receive elastic taping-augmented FMPT and general jogging exercise with non-elastic taping, respectively, for 12 weeks (2 hours/week). Major outcome measures: body balance and leg muscle activity will be measured via muscle sensors along with a force platform. Secondary outcome measures: leg muscle strength, motor proficiency and functional independence will be assessed by a digital dynamometer, the Movement Assessment Battery for Children-2 and Pediatric Evaluation of Disability Inventory, respectively (before- and after-intervention measurements).
Significance: The KT-FMPT group is predicted to display much better muscular and motor performances than the control group. This novel training program can be readily adopted in clinical, school, or home settings to improve functional independence in children with DCD, an outcome with positive socioeconomic implications. Moreover, study findings will inspire future research work in children with other childhood-onset disabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KT-FMPT group | Experimental | Behavioral: Kinesio Taping - Functional Movement Power Training |
| Control group | Placebo comparator | Behavioral: Jogging with placebo taping |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6- to 12-years-old
- classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V
- score < 5th percentile on the Movement Assessment Battery for Children, 2nd edition (MABC-2)
- total score < 46 on the DCD questionnaire (2007)
- attending a mainstream primary school with intelligence level within the normal range
Key exclusion criteria (4 listed)
- any known congenital, cognitive, psychiatric, neurological, sensorimotor, musculoskeletal or cardiopulmonary disorder that may affect test performance
- receiving active rehabilitation treatment
- demonstrating excessive disruptive behaviour
- unable to follow instructions
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 |
|---|---|---|
| Kinesio Taping - Functional Movement Power TrainingSubjects assigned to the Kinesio Taping - Functional Movement Power Training (KT-FMPT) group will receive FMPT concurrent with KT. The FMPT protocol was developed by the research team with reference to common physiotherapeutic exercises for children with motor disabilities.9 It comprises 5 functional movement exercises and 6 lower-limb power/resistance training exercises using weights or resistance bands. | Behavioural | KT-FMPT group |
| Jogging with placebo tapingSubjects assigned to the control group will receive no FMPT or KT, but participate in a jogging intervention with placebo tape applied on their calf muscles and removed after the intervention. | Behavioural | Control group |
Primary outcome
Change in leg muscle electromyographic activation onset latency time (in ms)
Time frame: 0 and 3 months
Electromyographic activation onset of leg muscles
Change in centre of pressure movement pathway in standing (in mm/cm)
Time frame: 0 and 3 months
Centre of pressure movement pathway in standing
3 secondary outcomes
Change in lower-extremity maximum isometric muscle strength (in kg/N)
Time frame: 0 and 3 months
Change in Movement Assessment Battery for Children-2 percentile score
Time frame: 0 and 3 months
Change in Pediatric Evaluation of Disability Inventory score
Time frame: 0 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping - Functional Movement Power Training 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 6 inclusion and 4 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 11 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
Change in leg muscle electromyographic activation onset latency time (in ms) (time frame: 0 and 3 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?
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 11 Oct 2019.