Therapeutic Riding and Neuromuscular Disease

Neuromuscular Disease Clinical Trial

— TR NMD  

Official title:

The Evaluation of Therapeutic Riding in Children and Adolescent With Kinetic Deficits Because of Neuromuscular Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621984
• Other study ID #: 274/21-9-2011
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2018
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Improvement in Gross Motor Function	Gross Motor Function measured by the Gross Motor Function Measure (GMFM)	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.
Secondary	Improvement in Gross Motor Performance	Gross Motor Performance measured by the Gross Motor Performance Measure (GMPM)	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.
Secondary	Decrease of spasticity	Spastisity measured by the Modified Ashworth Scale	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.
Secondary	Improvement in Quality of life	Quality of life measured by the Quality of life Questionnaire for Children	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.