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NCT Number: NCT01621984

Therapeutic Riding and Neuromuscular Disease

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.

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Key information

Conditions

Neuromuscular Disease Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital of Ioannina

Ioannina, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Riding/ Hippotherapy Intervention

Other

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 names: therapeutic riding/hippotherapy

Primary outcomes

  1. 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.

    posture control measured by the dynamic plate in combination with x-ray.

  2. 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.

    Balance measured by the Pediatric Balance Scale

Secondary outcomes

  1. 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.

    Gross Motor Function measured by the Gross Motor Function Measure (GMFM)

  2. 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.

    Gross Motor Performance measured by the Gross Motor Performance Measure (GMPM)

  3. 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.

    Spastisity measured by the Modified Ashworth Scale

  4. 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.

    Quality of life measured by the Quality of life Questionnaire for Children

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

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

Acronym: TR NMD

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2012
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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