Therapeutic Riding and Neuromuscular Disease (TR NMD)
Primary Purpose
Neuromuscular Disease
Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Therapeutic Riding/ Hippotherapy Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Disease focused on measuring Cerebral palsy, brain injury, spinal cord injuries, muscular disease
Eligibility Criteria
Inclusion Criteria:
- Children with neuromuscular disease
- Parental consent
- Sitting posture capability
- Hip abduction capability on horseback
- Ability to communicate and collaborate with the researcher
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital of Ioannina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Therapeutic Riding/ Hippotherapy
without Therapeutic Riding/ Hippotherapy
Arm Description
12 week Therapeutic Riding program that focused on gross motor function, gross motor performance, balance, spasticity, posture and quality of life
Outcomes
Primary Outcome Measures
Change from baseline in posture control at different time points
posture control measured by the dynamic plate in combination with x-ray.
Change from baseline in balance at different time points
Balance measured by the Pediatric Balance Scale
Secondary Outcome Measures
Improvement in Gross Motor Function
Gross Motor Function measured by the Gross Motor Function Measure (GMFM)
Improvement in Gross Motor Performance
Gross Motor Performance measured by the Gross Motor Performance Measure (GMPM)
Decrease of spasticity
Spastisity measured by the Modified Ashworth Scale
Improvement in Quality of life
Quality of life measured by the Quality of life Questionnaire for Children
Full Information
NCT ID
NCT01621984
First Posted
June 12, 2012
Last Updated
November 15, 2018
Sponsor
University of Ioannina
1. Study Identification
Unique Protocol Identification Number
NCT01621984
Brief Title
Therapeutic Riding and Neuromuscular Disease
Acronym
TR NMD
Official Title
The Evaluation of Therapeutic Riding in Children and Adolescent With Kinetic Deficits Because of Neuromuscular Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (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 Ioannina
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disease
Keywords
Cerebral palsy, brain injury, spinal cord injuries, muscular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Riding/ Hippotherapy
Arm Type
Experimental
Arm Description
12 week Therapeutic Riding program that focused on gross motor function, gross motor performance, balance, spasticity, posture and quality of life
Arm Title
without Therapeutic Riding/ Hippotherapy
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Therapeutic Riding/ Hippotherapy Intervention
Other Intervention Name(s)
therapeutic riding/hippotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in posture control at different time points
Description
posture control measured by the dynamic plate in combination with x-ray.
Time Frame
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.
Title
Change from baseline in balance at different time points
Description
Balance measured by the Pediatric Balance Scale
Time Frame
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 Outcome Measure Information:
Title
Improvement in Gross Motor Function
Description
Gross Motor Function measured by the Gross Motor Function Measure (GMFM)
Time Frame
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.
Title
Improvement in Gross Motor Performance
Description
Gross Motor Performance measured by the Gross Motor Performance Measure (GMPM)
Time Frame
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.
Title
Decrease of spasticity
Description
Spastisity measured by the Modified Ashworth Scale
Time Frame
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.
Title
Improvement in Quality of life
Description
Quality of life measured by the Quality of life Questionnaire for Children
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with neuromuscular disease
Parental consent
Sitting posture capability
Hip abduction capability on horseback
Ability to communicate and collaborate with the researcher
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avraam Ploumis
Organizational Affiliation
University Hospital, Ioannina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Riding and Neuromuscular Disease
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