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
+44 1825 722112
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.
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 results in http://onlinelibrary.wiley.com/doi/10.1111/dmcn.12780_23/full