NCT02945124

Brief 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).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3.9 years

First QC Date

September 10, 2016

Last Update Submit

October 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in lower limb muscle activation as measured by electromyography

    Post K Tape lower limb muscle activity - pre K Tape lower limb muscle activation

    Day 1 and day 2 (ms)

Secondary Outcomes (4)

  • Change in balance performance as measured by force plate

    Day 1 and day 2

  • Foot posture as assessed by clinical observation

    Day 1 and Day 2

  • Body composition as assessed by DXA

    Day 1 and Day 2

  • Change in walking pattern as assessed by a motion analysis system

    Day 1 and day 2

Study Arms (4)

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

Interventions

K tapeOTHER

Applying K tape to children to the lower limb muscles during motor activities.

DCD with K TapeNormal children with K Tape

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Pokfulam, Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Siu Ming Fong, 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
Assistant Professor

Study Record Dates

First Submitted

September 10, 2016

First Posted

October 26, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations