Clinical trial NCT01621984: Therapeutic Riding and Neuromuscular Disease
Official title: The Evaluation of Therapeutic Riding in Children and Adolescent With Kinetic Deficits Because of Neuromuscular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuromuscular Disease
Keywords: Cerebral palsy
brain injury
spinal cord injuries
muscular disease
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in posture control at different time points
timeFrame: 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.
measure: Change from baseline in balance at different time points
timeFrame: 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:
measure: Improvement in Gross Motor Function
timeFrame: 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.
measure: Improvement in Gross Motor Performance
timeFrame: 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.
measure: Decrease of spasticity
timeFrame: 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.
measure: Improvement in Quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
Study officials:
affiliation: University Hospital, Ioannina
name: Avraam Ploumis
role: PRINCIPAL_INVESTIGATOR
References: