NCT04123912

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration 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

First Submitted

Initial submission to the registry

October 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 8, 2019

Last Update Submit

October 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in leg muscle electromyographic activation onset latency time (in ms)

    Electromyographic activation onset of leg muscles

    0 and 3 months

  • Change in centre of pressure movement pathway in standing (in mm/cm)

    Centre of pressure movement pathway in standing

    0 and 3 months

Secondary Outcomes (3)

  • Change in lower-extremity maximum isometric muscle strength (in kg/N)

    0 and 3 months

  • Change in Movement Assessment Battery for Children-2 percentile score

    0 and 3 months

  • Change in Pediatric Evaluation of Disability Inventory score

    0 and 3 months

Study Arms (2)

KT-FMPT group

EXPERIMENTAL
Behavioral: Kinesio Taping - Functional Movement Power Training

Control group

PLACEBO COMPARATOR
Behavioral: Jogging with placebo taping

Interventions

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.

KT-FMPT group

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.

Control group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Jogging

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RunningLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

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
Dr

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 11, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

October 11, 2019

Record last verified: 2019-10

Locations