Therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy

ISRCTN	ISRCTN03663478
DOI	https://doi.org/10.1186/ISRCTN03663478
Protocol serial number	N/A
Sponsor	Regional Government of Aragon (Spain)
Funder	Regional Government of Aragon (Spain) - Department of Research, Innovation and Development (ref: PM059/2007)

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

C/ Belle Epoque 27 Local
Zaragoza
50019
Spain

Phone	+34 646 16 82 48
Email	info@aidimo.org

Study information

Primary study design	Interventional
Study design	Randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	Satisfaction of participants, measured using a 0 - 10 scale.
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	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

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?
Protocol article	protocol	16/04/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes