The role of foot orthoses in children with developmental coordination disorder

ISRCTN	ISRCTN59547425
DOI	https://doi.org/10.1186/ISRCTN59547425
Protocol serial number	N/A
Sponsor	Canonbury Products Ltd (UK)
Funder	Canonbury Products Ltd (UK) - supported with a £5000 research prize

Submission date: 13/02/2008
Registration date: 04/03/2008
Last edited: 20/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stewart Morrison
Scientific

School of Health and Bioscience
Romford Road
University of East London
London
E15 4LZ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial. The children will be quasi-randomised into two groups.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot study to evaluate the benefit of foot orthoses prescribed in the rehabilitation of children with developmental coordination disorder
Study objectives	Developmental coordination disorder (DCD) is a defined as a "motor skill disorder characterised by a marked impairment in the development of motor coordination abilities" (American Psychiatric Association, 2004) and such a condition will affect the execution of everyday tasks. Characteristics of DCD noted within the literature include poor balance, delayed developmental characteristics and a "clumsy" and "awkward" gait (Polatajko and Cantin, 2006). DCD is reported to have an impact upon both fine and gross motor skills which results in limited participation in everyday activities of childhood (Polatajko and Cantin, 2006). Further impact of DCD has been reported as limited academic achievement, reduced participation in sport and implications for psycho-social development; particularly with regards to limited interaction with peers. (Polatajko and Cantin, 2006). Hypotheses: 1. Do University of California Biomechanics Laboratory (UCBL) foot orthoses improve balance and reduce tripping in children with DCD? 2. Do UCBL foot orthoses normalise the spatial and temporal gait parameters in children with DCD?
Ethics approval(s)	Lewisham LREC, 11/06/2008, ref: 08/H0810/38
Health condition(s) or problem(s) studied	Developmental coordination disorder (DCD)
Intervention	UCBL foot orthoses are being used in the study. The effect of the foot orthoses in the management of DCD diagnosed children will be determined by comparing the two groups of children: 1. One group of children will be prescribed their orthoses at the start of the seven week rehabilitation programme 2. One group of children will be prescribed their orthoses at the end of the seven week programme This will allow all children who would normally be prescribed orthoses to receive orthoses - no children will be prevented from receiving the treatment that they would normally have because they are participating in the study. The intervention will be assessed over a period of seven weeks; once at the start of the seven week programme and once at the end. These foot orthoses currently form part of the multi-disciplinary management of children with DCD therefore, the duration will be as long as the subject requires them.
Intervention type	Other
Primary outcome measure(s)	The GAITRite Gold Footmat will be used in the study to identify spatio-temporal gait parameters. This is a walkway which is embedded with sensors. The GAITRite system can provide measurements of spatial parameters such as step length, stride length, base of gait, angle of progression; it can provide measurements of temporal parameters such as cadence, velocity, stance phase duration, swing phase duration. Previous studies have identified the following parameters as being changed in children with DCD: 1. Single support duration (decreased) 2. Swing phase (decreased) 3. Cadence (increased) 4. Stride length (decreased) These parameters will be used as primary outcome measures and recorded pre- and post-provision of foot orthoses, assessed at the start and end of the seven week programme.
Key secondary outcome measure(s)	The Bruininks-Oseretsky test of motor proficiency (BOT) is a tool that measures improvement in function in children using an individually administered measure of gross and fine motor skills. The score consists of eight subtests which assess: 1. Fine motor precision: seven items (e.g., cutting out a circle, connecting dots) 2. Fine motor integration: eight items (e.g., copying a star, copying a square) 3. Manual dexterity: five items (e.g., transferring pennies, sorting cards, stringing blocks) 4. Bilateral coordination: seven items (e.g., tapping foot and finger, jumping jacks) 5. Balance: nine items (e.g., walking forward on a line, standing on one leg on a balance beam) 6. Running speed and agility: five items (e.g., shuttle run, one-legged side hop) 7. Upper-limb coordination: seven items (e.g., throwing a ball at a target, catching a tossed ball) 8. Strength: five items (e.g., standing long jump, sit-ups) The data taken from BOT composite scores will be used in secondary analysis. This will include body coordination, strength and agility and total motor composite scores. Secondary outcome measures will be assessed at the start and end of the seven week programme.
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	The study population will be composed of children entering the multi-disciplinary therapy programme at the Sanderson Child Development Centre, Medway Maritime Hospital. Children entering this programme: 1. Have an established diagnosis of DCD 2. Will be aged 7 years and over
Key exclusion criteria	1. Any relevant medical complications that are likely to prevent a change in gait parameters. This includes any condition affecting neuromuscular integrity and orthopaedic condition causing a gait disturbance. 2. Unwilling to wear footwear that is suitable to use with an orthoses (low heeled, fastening, supportive footwear)
Date of first enrolment	01/06/2008
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of East London

London
E15 4LZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/06/2016: No publications found, verifying study status with principal investigator.