The Introduction of Petra Running-bikes: A Pilot Study
| ISRCTN | ISRCTN37572029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37572029 |
| Secondary identifying numbers | 15075 |
- 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
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 |
|---|---|
| liz.bryant@nhs.net |
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 19/08/2013 |
| Completion date | 01/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 12; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Speech and Language Therapy Department
Near Lewes
BN8 4JN
United Kingdom
BN8 4JN
United Kingdom
Sponsor information
Sussex Community NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Freshfield Annex
Brighton General Hospital Elm Grove
Brighton
BN2 3EW
England
United Kingdom
"ROR" |
https://ror.org/04e4sh030 |
|---|
Funders
Funder type
Charity
Sparks Charity (UK) Grant Codes: 11CHY01
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
