Back to resultsMuscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy
Primary Purpose
Neuromuscular Diseases in Children, Cerebral Palsy, Spastic, Spasticity, Muscle
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hippotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Diseases in Children focused on measuring hippotherapy, cerebral palsy, spasticity
Eligibility Criteria
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.
Sites / Locations
- Faculty of Nursing and Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
Children will receive hippotherapy by a licensed physical therapist. Before riding, stretching and warming exercises of the adductor muscles will be performed. Later, the patient will be seated astride with the therapist behind. In any case, the participant had no control of the horse. Therapist will be responsible for correctly positioning the subject on the horse, but no position changes or active intervention of the subject with the therapist will be made. This positioning consists on achieving the optimal body alignment with neutral pelvis.
Children will receive the conventional treatment, based on physiotherapy related techniques, such as neurodevelopmental treatment (twice a week).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03212846
Brief Title
Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy
Official Title
Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases in Children, Cerebral Palsy, Spastic, Spasticity, Muscle
Keywords
hippotherapy, cerebral palsy, spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Radomized controlled trial with two groups: intervention group (hippotherapy + conventional treatment) and control group (conventional treatment).
Masking
Outcomes Assessor
Masking Description
Single blind
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Children will receive hippotherapy by a licensed physical therapist. Before riding, stretching and warming exercises of the adductor muscles will be performed. Later, the patient will be seated astride with the therapist behind. In any case, the participant had no control of the horse. Therapist will be responsible for correctly positioning the subject on the horse, but no position changes or active intervention of the subject with the therapist will be made. This positioning consists on achieving the optimal body alignment with neutral pelvis.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children will receive the conventional treatment, based on physiotherapy related techniques, such as neurodevelopmental treatment (twice a week).
Intervention Type
Other
Intervention Name(s)
Hippotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Nursing and Physiotherapy
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No provided.
Citations:
PubMed Identifier
17057544
Citation
Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004 Fall;16(3):165-72. doi: 10.1097/01.PEP.0000136003.15233.0C.
Results Reference
background
PubMed Identifier
9881805
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. doi: 10.1111/j.1469-8749.1998.tb12344.x.
Results Reference
background
PubMed Identifier
22122355
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.
Results Reference
background
PubMed Identifier
17209981
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. doi: 10.1017/s0012162207000175.x.
Results Reference
result
PubMed Identifier
21729249
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 Mar 24.
Results Reference
result
PubMed Identifier
21530725
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.
Results Reference
result
PubMed Identifier
19480872
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: 10.1016/j.apmr.2009.01.011.
Results Reference
result
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Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy
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