Developmental Coordination DisorderNCT02945124
Taping for Children With and Without Movement Clumsiness
A study testing K tape in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD). Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- K tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2016to Dec 2019
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with DCD and typically developing children will need to score <16 percentile and >25 percentile, respectively, on MABC-2
- Study in mainstream schools
- No intellectual disabilities
Who cannot join
- Subjects who are receiving regular treatments
- Demonstrate excessive disruptive behaviour
- Unable to follow instructions
- Any diagnosis of neurological, musculoskeletal or cognitive disorder that affects test performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of K-Tape on Walking Pattern, Muscle Activity, and Motor Performance in Children With and Without Developmental Coordination Disorder: a Randomized Controlled Trial
To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD).
- Conditions
- Developmental Coordination Disorder
- Being tested
- K tape
- 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.
K tapeOther
Applying K tape to children to the lower limb muscles during motor activities.
| Study group | Role | What they receive |
|---|---|---|
| Normal children with K Tape | Experimental | Not described Receives: Other: K tape |
| Normal children without K Tape | No intervention | Not described |
| DCD with K Tape | Experimental | Not described Receives: Other: K tape |
| DCD without K Tape | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb muscle activation as measured by electromyography
Post K Tape lower limb muscle activity - pre K Tape lower limb muscle activation
Measured: Day 1 and day 2 (ms)
Secondary outcomes (4)
Change in balance performance as measured by force plate
Post K Tape balance performance - pre K Tape balance performance
Measured: Day 1 and day 2
Foot posture as assessed by clinical observation
Measured: Day 1 and Day 2
Body composition as assessed by DXA
Measured: Day 1 and Day 2
Change in walking pattern as assessed by a motion analysis system
Post K Tape walking pattern - pre K Tape walking pattern
Measured: Day 1 and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (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
- 200 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
- Siu Ming Fong, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945124
- Sponsor's protocol ID
- EA1512037
- Status last verified
- Oct 2016
- First submitted
- 10 Sep 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fong SSM, Ng SSM, Guo X, Wang Y, Chung RCK, Stat G, Ki WY, Macfarlane DJ. Deficits in Lower Limb Muscle Reflex Contraction Latency and Peak Force Are Associated With Impairments in Postural Control and Gross Motor Skills of Children With Developmental Coordination Disorder: A Cross-Sectional Study. Medicine (Baltimore). 2015 Oct;94(41):e1785. doi: 10.1097/MD.0000000000001785.
PubMed 26469921
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of K-Tape on Walking Pattern, Muscle Activity, and Motor Performance in Children With and Without Developmental Coordination Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02945124
- Acronym / sponsor ID
- EA1512037
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- First posted
- 26 Oct 2016 (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.
To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal children with K Tape | Experimental | Other: K tape |
| Normal children without K Tape | No intervention | – |
| DCD with K Tape | Experimental | Other: K tape |
| DCD without K Tape | No intervention | – |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with DCD and typically developing children will need to score <16 percentile and >25 percentile, respectively, on MABC-2
- Study in mainstream schools
- No intellectual disabilities
Key exclusion criteria (4 listed)
- Subjects who are receiving regular treatments
- Demonstrate excessive disruptive behaviour
- Unable to follow instructions
- Any diagnosis of neurological, musculoskeletal or cognitive disorder that affects test performance
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 |
|---|---|---|
| K tapeApplying K tape to children to the lower limb muscles during motor activities. | Other | DCD with K Tape, Normal children with K Tape |
Primary outcome
Change in lower limb muscle activation as measured by electromyography
Time frame: Day 1 and day 2 (ms)
Post K Tape lower limb muscle activity - pre K Tape lower limb muscle activation
4 secondary outcomes
Change in balance performance as measured by force plate
Time frame: Day 1 and day 2
Foot posture as assessed by clinical observation
Time frame: Day 1 and Day 2
Body composition as assessed by DXA
Time frame: Day 1 and Day 2
Change in walking pattern as assessed by a motion analysis system
Time frame: Day 1 and day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Results publication: PubMed 26469921Fong SSM, Ng SSM, Guo X, Wang Y, Chung RCK, Stat G, Ki WY, Macfarlane DJ. Deficits in Lower Limb Muscle Reflex Contraction Latency and Peak Force Are Associated With Impairments in Postural Control and Gross Motor Skills of Children With Developmental Coordination Disorder: A Cross-Sectional Study. Medicine (Baltimore). 2015 Oct;94(41):e1785. doi: 10.1097/MD.0000000000001785.
- Individual participant dataSharing planned: No
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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.
Siu Ming Fong, 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 K tape 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 3 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 26 Oct 2016. 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?
Change in lower limb muscle activation as measured by electromyography (time frame: Day 1 and day 2 (ms)). 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 NCT02945124, 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 26 Oct 2016.