Condition category
Nervous System Diseases
Date applied
17/12/2013
Date assigned
17/12/2013
Last edited
17/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Bryant

ORCID ID

Contact details

Speech and Language Therapy Department
Chailey Heritage Clinical Services
Beggars Wood Road North Chailey
Near Lewes
BN8 4JN
United Kingdom
liz.bryant@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15075

Study information

Scientific title

The introduction of Petra running-bikes to encourage and facilitate weight-bearing exercise for children with cerebral palsy who are unable to walk independently: a pilot study

Acronym

Study hypothesis

Cerebral palsy (CP) is an umbrella term used for disabilities resulting from damage to the brain in the early stages of development and causing motor (movement) difficulties. Poor physical mobility results in reduced weight-bearing activity and since weight-bearing activity is essential for normal bone development, these children are more likely to develop osteoporosis (bone thinning). The benefit of weightbearing exercise for typically developing children is well documented, in terms of improvements observed in muscle strength, bone health and functional ability. This pilot study will introduce a novel mobility device, Petra running-bikes,to a group of children with CP who are unable to walk independently to investigate whether it is a feasible and enjoyable mode of weightbearing exercise facilitating their participation in physical activity. Running-bikes have a unique design with postural supports enabling non-ambulant children to weight-bear in a supported position. As opposed to a pedalling system the user sits on the saddle and propels themselves forward by contact with his/her feet on the ground.

A minimum of twelve children with CP, aged 4-12 years, will be recruited to the study to trial the running-bikes for twelve weeks (one school term). Each child will be provided with a running-bike appropriately sized and individually adapted according to their requirements. The children will use the running-bikes within their specialist schools three times a week.

At the end of the trial the physiotherapists and children will be interviewed to find out their views and experiences of using the running-bike. Any changes in bone status, motor function (mobility), quality of life and ability to use therunning-bike will be investigated.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15075

Ethics approval

13/LO/0577; First MREC approval date 06/06/2013

Study design

Non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics

Intervention

A minimum of 12 children aged 4-12 years will be recruited for this pilot study. This will provide sufficient data to answer the research question "can non-ambulant children with cerebral palsy use and enjoy runningbikes?"

This will provide a range of ages and levels of disability to allow a wide spread of children and is considered appropriate for a pilot study.

Intervention, Each participant will be issued with a running bike to use at school for 12 weeks (three times a week) during their physiotherapy or PE session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ability to use the running bike; Timepoint(s): This will be assessed and scored on 3 occassions (baseline, week 6 and week 12).

Secondary outcome measures

1. Bone health; Timepoint(s): Bone status will be assessed using an ultrasound bone densitometer at baseline and week 12
2. Focus group feedback from participants; Timepoint(s): Week 13
3. Gross Motor Function; Timepoint(s): Standing ability will be assessed at baseline and week 12
4. Quality of life; Timepoint(s): QoL will be assessed at baseline and week 12.

Overall trial start date

19/08/2013

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children with CP aged 4 to 12 years
2. Children with CP who are unable to walk independently (Gross Motor Function Classification levels III, IV or V)
3. Ability to follow instructions to use the running-bikes
4. Target Gender: Male & Female

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 12; UK Sample Size: 12

Participant exclusion criteria

1. Children under the age of 4, or over the age of 12 years.
2. Children with CP who are able to walk (Gross Motor Function Classification Levels I or II)
3. Children who have undergone orthopaedic surgery to the spine or lower limbs within the last six months (due to the risk of fracture).
4. Children with a history of leg fractures (who may be vulnerable to further fracture).
5. Children with cognitive or behavioural impairment (preventing simple instructions on how to manoevre the running-bike).
6. Children with serious visual impairment (safety issues regarding using the runningbike).

Recruitment start date

19/08/2013

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Speech and Language Therapy Department
Near Lewes
BN8 4JN
United Kingdom

Sponsor information

Organisation

Sussex Community NHS Trust (UK)

Sponsor details

Research and Development
Freshfield Annex
Brighton General Hospital Elm Grove
Brighton
BN2 3EW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Sparks Charity (UK) Grant Codes: 11CHY01

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