Condition category
Nervous System Diseases
Date applied
19/02/2009
Date assigned
27/02/2009
Last edited
20/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pablo Herrero

ORCID ID

Contact details

C/ Belle Epoque 27 Local
Zaragoza
50019
Spain
+34 646 16 82 48
info@aidimo.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial

Acronym

Study hypothesis

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

Local Ethics Committee (CEIC Aragón) gave approval on the 6th June 2008 (ref: CP04/06/08)

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

37

Participant 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

Recruitment start date

01/10/2008

Recruitment end date

01/10/2009

Locations

Countries of recruitment

Spain

Trial participating centre

C/ Belle Epoque 27 Local
Zaragoza
50019
Spain

Sponsor information

Organisation

Regional Government of Aragon (Spain)

Sponsor details

Department of Research
Innovation and Development
Paseo María Agustín 36
Puerta 30 1ª planta
Zaragoza
50008
Spain
aasensio@unizar.es

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Regional Government of Aragon (Spain) - Department of Research, Innovation and Development (ref: PM059/2007)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20398394

Publication citations

  1. Protocol

    Herrero P, Asensio A, García E, Marco A, Oliván B, Ibarz A, Gómez-Trullén EM, Casas R, Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial., BMC Musculoskelet Disord, 2010, 11, 71, doi: 10.1186/1471-2474-11-71.

Additional files

Editorial Notes