Condition category
Nervous System Diseases
Date applied
04/07/2012
Date assigned
16/08/2012
Last edited
19/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Children who sustain damage to the developing brain often develop contractures (a permanent shortening of a muscle or joint) leading to thumb and wrist deformity. Early intervention with elastic taping prior to the development of contractures may help to improve thumb and wrist position, and hopefully have beneficial effects on function. However, this approach has not been well evaluated although it has begun to be used in clinical practice.

We aim to determine the feasibility and acceptability of using elastic taping for this purpose in infants and young children, and to look for effects on hand and wrist posture and function.

Who can participate?
We are recruiting 20 infants and young children aged 6 months to 3 years who have difficulties with hand and wrist posture and use, worse on one side than the other, following an injury to the developing brain. Potential participants will be identified by their clinicians or therapists at Newcastle upon Tyne NHS Hospitals Foundation Trust, UK.

What does the study involve?
Children will be randomly allocated to one of two groups. One group will receive routine care for 2 weeks then taping for 2 weeks. The other group will receive taping for the 4-week period of the study. Videotaped assessments of hand and wrist posture and function will be undertaken at baseline, 2 and 4 weeks with tape on and tape off. Families will also complete a home diary and questionnaire to provide feedback regarding the experience.

What are the possible benefits and risks of participating?
Taping is noninvasive and safe. We will check for skin sensitivity to the tape. We cannot be sure at this stage whether taping is beneficial. However, if taping is felt to help a participant, treatment will be continued after the study within the clinical service.

Where is the study run from?
The study will be run from the Child Development Centre, Newcastle upon Tyne NHS Hospitals Foundation Trust, UK.

When is study starting and how long is it expected to run for?
The study is expected to start in September 2012 and run for 2 years.

Who is funding the study?
The study is funded through the British Academy of Childhood Disability/Royal College of Paediatrics and Child Health (UK).

Who is the main contact?
Dr Anna Basu (anna.basu@ncl.ac.uk)
Dr Jill Kisler (jill.kisler@nuth.nhs.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jill Kisler

ORCID ID

Contact details

Child Development Centre
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE14LP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can taping improve hand posture and use in infants with brain lesions? A feasibility study

Acronym

Study hypothesis

The aim of this pilot study is to determine, in infants and young children with asymmetric brain injury affecting hand posture and function:
1. The feasibility and acceptability of using elastic tape applied to the thumb, wrist and arm
2. Whether the elastic tape has a beneficial effect on hand and wrist posture and function both immediately when applied and in the longer term.

Ethics approval

Not provided at time of registration

Study design

Pilot randomised single-blinded (assessor) single-centre study. Based on a randomised cross-over design except that in the second time interval both groups will receive the intervention.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elastic tape as intervention for hand and wrist posture and function after early brain damage

Intervention

Application of elastic tape with intent to improve thumb and wrist posture and function.

Children will be randomised to one of two groups, one receiving routine care for 2 weeks then taping for 2 weeks. The other group will receive taping for the 4 week period of the study. Videotaped assessments of hand and wrist posture and function will be undertaken at baseline, 2 and 4 weeks with tape on and tape off. Families will also complete a home diary and questionnaire to provide feedback regarding the experience.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Feasibility and acceptability of the intervention
2. Change in score on Assisting Hand Assessment (AHA)

Secondary outcome measures

1. Measure of thumb position: House Thumb classification
2. Measure of hand and wrist position: Zancolli classification

Overall trial start date

03/09/2012

Overall trial end date

03/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants and young children age 6 months to 3 years
2. Asymmetric abnormalities of hand and wrist posture and function secondary to non-progressive brain lesions and including acquired brain injury

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Known allergy to tape adhesive
2. Known progressive or degenerative disorder
3. Already recruited to another trial
4. Other splinting already in use

Recruitment start date

03/09/2012

Recruitment end date

03/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Child Development Centre
Newcastle upon Tyne
NE14LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne NHS Hospitals Foundation Trust (UK)

Sponsor details

Joint Research Office
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

British Academy of Childhood Disability (UK) - Paul Polani Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes