Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Elizabeth Bryant


Contact details

Speech and Language Therapy Department
Chailey Heritage Clinical Services
Beggars Wood Road North Chailey
Near Lewes
United Kingdom
+44 1825 722112

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet


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


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Speech and Language Therapy Department
Near Lewes
United Kingdom

Sponsor information


Sussex Community NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Sparks Charity (UK) Grant Codes: 11CHY01

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

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