The Introduction of Petra Running-bikes: A Pilot Study

ISRCTN	ISRCTN37572029
DOI	https://doi.org/10.1186/ISRCTN37572029
Protocol serial number	15075
Sponsor	Sussex Community NHS Trust (UK)
Funder	Sparks Charity (UK) Grant Codes: 11CHY01

Submission date: 17/12/2013
Registration date: 17/12/2013
Last edited: 26/01/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Elizabeth Bryant
Scientific

Speech and Language Therapy Department
Chailey Heritage Clinical Services
Beggars Wood Road North Chailey
Near Lewes
BN8 4JN
United Kingdom

Phone	+44 1825 722112
Email	liz.bryant@nhs.net

Study information

Primary study design	Interventional
Study design	Non-randomised interventional trial
Secondary study design	Non randomised controlled trial
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
Study objectives	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(s)	13/LO/0577; First MREC approval date 06/06/2013
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Ability to use the running bike; Timepoint(s): This will be assessed and scored on 3 occassions (baseline, week 6 and week 12).
Key secondary outcome measure(s)	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.
Completion date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	12
Key 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
Key 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).
Date of first enrolment	19/08/2013
Date of final enrolment	01/10/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Speech and Language Therapy Department

Near Lewes
BN8 4JN
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?
Results article	results	01/05/2015		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

26/01/2017: No publications found in PubMed, verifying study status with principal investigator.