Therapeutic Riding and Neuromuscular Disease (TR NMD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Ioannina
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01621984
First received: June 12, 2012
Last updated: January 7, 2014
Last verified: January 2014
  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 2015
Estimated Primary Completion Date: November 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 7, 2014
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 August 19, 2014