Trial record 1 of 716 for:
Open Studies | "Neuromuscular Diseases"
Therapeutic Riding and Neuromuscular Disease (TR NMD)
This study is currently recruiting participants.
Verified May 2013 by University of Ioannina
Sponsor:
University of Ioannina
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01621984
First received: June 12, 2012
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuromuscular Disease |
Other: Therapeutic Riding/ Hippotherapy Intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Evaluation of Therapeutic Riding in Children and Adolescent With Kinetic Deficits Because of Neuromuscular Disease. |
Resource links provided by NLM:
Further study details as provided by University of Ioannina:
Primary Outcome Measures:
- Change from baseline in posture control at different time points [ 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. ] [ Designated as safety issue: No ]posture control measured by the dynamic plate in combination with x-ray.
- Change from baseline in balance at different time points [ 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. ] [ Designated as safety issue: No ]Balance measured by the Pediatric Balance Scale
Secondary Outcome Measures:
- Improvement in Gross Motor Function [ 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. ] [ Designated as safety issue: No ]Gross Motor Function measured by the Gross Motor Function Measure (GMFM)
- Improvement in Gross Motor Performance [ 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. ] [ Designated as safety issue: No ]Gross Motor Performance measured by the Gross Motor Performance Measure (GMPM)
- Decrease of spasticity [ 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. ] [ Designated as safety issue: No ]Spastisity measured by the Modified Ashworth Scale
- Improvement in Quality of life [ 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. ] [ Designated as safety issue: No ]Quality of life measured by the Quality of life Questionnaire for Children
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Therapeutic Riding/ Hippotherapy
12 week Therapeutic Riding program that focused on gross motor function, gross motor performance, balance, spasticity, posture and quality of life
|
Other: Therapeutic Riding/ Hippotherapy Intervention
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.
Other Name: therapeutic riding/hippotherapy
|
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621984
Contacts
| Contact: Alexandra Stergiou | 00306936892931 | asterg@cc.uoi.gr |
Locations
| Greece | |
| University Hospital of Ioannina | Recruiting |
| Ioannina, Greece | |
| Contact: Alexandra Stergiou 00306936892931 asterg@cc.uoi.gr | |
| Principal Investigator: Avraam Ploumis, Assistant Professor | |
| Sub-Investigator: Alexandra Stergiou, Physical Education Instructor | |
Sponsors and Collaborators
University of Ioannina
Investigators
| Principal Investigator: | Avraam Ploumis | University Hospital, Ioannina |
More Information
No publications provided
| Responsible Party: | Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina |
| ClinicalTrials.gov Identifier: | NCT01621984 History of Changes |
| Other Study ID Numbers: | 274/21-9-2011 |
| Study First Received: | June 12, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by University of Ioannina:
|
Cerebral palsy brain injury spinal cord injuries muscular disease |
Additional relevant MeSH terms:
|
Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013