Therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy
| ISRCTN | ISRCTN03663478 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03663478 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/02/2009
- Registration date
- 27/02/2009
- Last edited
- 20/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Pablo Herrero
Scientific
Scientific
C/ Belle Epoque 27 Local
Zaragoza
50019
Spain
| Phone | +34 646 16 82 48 |
|---|---|
| info@aidimo.org |
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial |
| Study objectives | To analyse the therapeutic effects or the contraindications of the use of a commercial hippotherapy simulator on several important factors relating to children with cerebral palsy (CP) such as their motor development, balance control in the sitting posture, hip abduction range of motion and electromyographic (EMG) activity of adductor musculature. |
| Ethics approval(s) | Local Ethics Committee (CEIC Aragón) gave approval on the 6th June 2008 (ref: CP04/06/08) |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | The patients were classified into five levels according to the Gross Motor Function Classification System and subsequently randomly divided into two treatment groups: 1. Treatment Group with hippotherapy simulator (maintaining sitting posture, with legs in abduction and rhythmic movement of the simulator) 2. Treatment Group maintaining sitting posture, with legs in abduction and without rhythmic movement of the simulator The randomising will be centralised and generated by computer to ensure a similar distribution of the possible confusion variables in both groups. The assignation sequence will be hidden. In cases where tutors or children do not wish to participate, their reasons will be recorded. The independent variable in this study is the assigned therapeutic modality (treatment with hippotherapy simulator, or maintenance of sitting posture with legs in abduction but without rhythmic movement of the emulator). Each child will receive 10 treatment sessions. There will be one session a week of 15 minutes. The children not included in the simulator group are offered 10 treatment sessions with the simulator after the study has been completed. The dependent variables are: 1. Sitting balance 2. Measurement of hip abduction range of motion 3. Electromyographic activity in adductors 4. Gross motor function Follow-up will continue until three months post-treatment completion. |
| Intervention type | Other |
| Primary outcome measure | Sitting balance: 1. Measurement of hip abduction range of motion, measured using an electronic inclinometer and traditional goniometer 2. Electromyographic activity in adductors, measured using surface electromyography (EMG) 3. Gross motor function, measured with the Gross Motor Function Measure (GMFM) and Sitting Assessment Scale (SAS) |
| Secondary outcome measures | Satisfaction of participants, measured using a 0 - 10 scale. |
| Overall study start date | 01/10/2008 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 37 |
| Key inclusion criteria | Children between 4 and 18 years old (either sex) with CP, who attend schools run by the Education Department of the Government of Aragon (Spain) and whose tutors have signed an informed consent form. |
| Key exclusion criteria | 1. Children who have undergone selective dorsal rhizotomy 2. Acute convulsions not controlled by medication 3. Allergy to electrode adhesives 4. Visual impairment not corrected with glasses 5. Those circumstances or associated illnesses that in the judgment of the researcher might interfere with the results or be detrimental to the children 6. Inability to attend intervention sessions or refusal to participate |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
C/ Belle Epoque 27 Local
Zaragoza
50019
Spain
50019
Spain
Sponsor information
Regional Government of Aragon (Spain)
Government
Government
Department of Research, Innovation and Development
Paseo María Agustín 36
Puerta 30 1ª planta
Zaragoza
50008
Spain
| aasensio@unizar.es | |
"ROR" |
https://ror.org/0425pg203 |
Funders
Funder type
Government
Regional Government of Aragon (Spain) - Department of Research, Innovation and Development (ref: PM059/2007)
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/04/2010 | Yes | No |
