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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03212846
Other study ID # CTS671
Secondary ID
Status Completed
Phase N/A
First received July 7, 2017
Last updated July 9, 2017
Start date June 2016
Est. completion date October 2016

Study information

Verified date July 2017
Source University of Cadiz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in addition to traditional treatment.


Description:

The main aim of the present study is to determine the effects of hippotherapy on the hip aductors spasticity in children with spastic cerebral palsy. Furthermore, as a secondary objective is to evaluate the changes in Modified Ashworth Scale (MAS) after intervention in children ages 3-14.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 3 Years to 14 Years
Eligibility Inclusion Criteria:

- Primor diagnosis of spastic cerebral palsy

- Children aged 3-14

Exclusion Criteria:

- Children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hippotherapy
Children will receive the hippotherapy treatment, based on horse walking in a regular way led by an experienced leader. Sessions will be performed for 45 minutes once weekly for 12 consecutive weeks in an indoor riding area.

Locations

Country Name City State
Spain Faculty of Nursing and Physiotherapy Cádiz

Sponsors (1)

Lead Sponsor Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004 Fall;16(3):165-72. — View Citation

Kwon JY, Chang HJ, Lee JY, Ha Y, Lee PK, Kim YH. Effects of hippotherapy on gait parameters in children with bilateral spastic cerebral palsy. Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031. — View Citation

McGibbon NH, Andrade CK, Widener G, Cintas HL. Effect of an equine-movement therapy program on gait, energy expenditure, and motor function in children with spastic cerebral palsy: a pilot study. Dev Med Child Neurol. 1998 Nov;40(11):754-62. — View Citation

McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: — View Citation

Sterba JA. Does horseback riding therapy or therapist-directed hippotherapy rehabilitate children with cerebral palsy? Dev Med Child Neurol. 2007 Jan;49(1):68-73. Review. — View Citation

Whalen CN, Case-Smith J. Therapeutic effects of horseback riding therapy on gross motor function in children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2012 Aug;32(3):229-42. doi: 10.3109/01942638.2011.619251. Epub 2011 Nov 29. Review. — View Citation

Zadnikar M, Kastrin A. Effects of hippotherapy and therapeutic horseback riding on postural control or balance in children with cerebral palsy: a meta-analysis. Dev Med Child Neurol. 2011 Aug;53(8):684-91. doi: 10.1111/j.1469-8749.2011.03951.x. Epub 2011 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Ashworth Scale (MAS) The aim of the scale is to assess muscle tone by the joint range of motion, manually evaluated, and clinically recording passive movements' resistance. Each participant will be examined lying supine on a couch in a relaxed position. The MAS scale is, undoubtedly, the most widely used measure for the quantification of muscular hypertonia. The trunk and the head will be maintained in a neutral position to avoid eliciting tonic neck reflexes, and the passive speed movements will be made in the course of one second. It will be performed in left and right hip, independently, 5 to 8 times to obtain a more reliable result. This modified version adds a 1+ scoring category, in order to register resistance in less than half of the range of motion. Thus, the scores range is from 0 to 4, with 6 choices. 12 weeks
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