Therapeutic Riding and Neuromuscular Disease
TR NMD
The Evaluation of Therapeutic Riding in Children and Adolescent With Kinetic Deficits Because of Neuromuscular Disease.
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this current prospective study is to assess the effects of a Therapeutic Riding exercise program conducted in patients suffering from neuromuscular disease. The exercise intervention aims at improving gross motor function, gross motor performance, balance, spasticity, posture and quality of life. Patients were randomized according to age, sex, mental ability and gross motor function. Furthermore, patients will be subdivided into categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve or muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40 minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control, the Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results will be collected and evaluated using the statistical programme SPSS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 19, 2018
November 1, 2018
4.3 years
June 12, 2012
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in posture control at different time points
posture control measured by the dynamic plate in combination with x-ray.
Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 one day before start of treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.
Change from baseline in balance at different time points
Balance measured by the Pediatric Balance Scale
Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 one day before start of treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.
Secondary Outcomes (4)
Improvement in Gross Motor Function
Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.
Improvement in Gross Motor Performance
Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.
Decrease of spasticity
Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.
Improvement in Quality of life
Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.
Study Arms (2)
Therapeutic Riding/ Hippotherapy
EXPERIMENTAL12 week Therapeutic Riding program that focused on gross motor function, gross motor performance, balance, spasticity, posture and quality of life
without Therapeutic Riding/ Hippotherapy
NO INTERVENTIONInterventions
The Therapeutic Riding exercise intervention consisted exercises for warm up,transitions on the horseback, stretching exercises and exercises to strengthen muscles of trunk and four limps, games with balls and rings and walking of the horse to change directions as diagonal / lateral changes, cycles with open and closed eyes.
Eligibility Criteria
You may qualify if:
- Children with neuromuscular disease
- Parental consent
- Sitting posture capability
- Hip abduction capability on horseback
- Ability to communicate and collaborate with the researcher
You may not qualify if:
- Children with Scheuermann disease
- uncontrolled seizures (A) child with generalized seizure over 2 minutes in the last three months (B) Children who are not well-adjusted levels of antiepileptic drugs.
- musculoskeletal disorder that may be aggravated by the movement of the horse such as atlantoaxial instability, osteoporosis etc.
- Scoliosis \> 30 degree
- Allergy to dust
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Ioannina
Ioannina, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avraam Ploumis
University Hospital, Ioannina
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of PMR, Orthopaedic Spine Surgeon
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 18, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 19, 2018
Record last verified: 2018-11