Clinical trial NCT03889262: Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
Official title: Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Physiotherapy and Rehabilitation
Hippotherapy
Balance
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop a simulated hippotherapy system controlled by electromyography (EMG) signals and investigate its effectiveness in children with cerebral palsy. In order to investigate its effectiveness evaluation of gross motor functions, lower extremity joint movements, spasticity of the lower extremities, functional independence, body movements, sitting and standing balance, muscle tone, stiffness and elasticity level, analysis of the walking are planned.

Detailed description: Hippotherapy is a therapeutic method in which a real horse is used for therapeutic purposes. It is widely used in many countries in the treatment of neuromuscular diseases (Multiple Sclerosis, stroke, Cerebral Palsy, etc.). Although the use of hippotherapy is widespread, many people can not reach and use this method effectively because of many reasons such as the high cost of caring, feeding, and sheltering horses or fear of people from horses. In recent years, hippotherapy simulation devices (mechanic and robotic horses) have been developed to overcome these problems. These devices aim to create the effects of hippotherapy on people by simulating a real horse's movement. The aim of this project is to develop and produce a simulated hippotherapy system, which can be controlled by electromyography (EMG) signals coming from the rider, movements programmable (for different musculoskeletal problems), rehabilitation-specific, providing evaluation during therapy, integrating virtual reality system and therapy games and investigate its effectiveness in children with cerebral palsy.

Eligibility criteria: Inclusion Criteria

* Having a diagnosis of Spastic Cerebral Palsy,
* Children aged between 5 - 18 years,
* Gross motor functional level is I, II or III,
* Independent seating
* Walking at least 10 meters independently,
* Can understand simple verbal instructions,
* Those with a spasticity level less than 2 according to Modified Ashworth Scale ,
* Having bilateral hip abduction enough to sit on the hippotherapy device,
* Voluntary acceptance to participate in the study

Exclusion Criteria

* Having hip dislocation,
* Severe contracture or deformity,
* Scoliosis (above 20 degrees),
* Acute uncontrolled acute seizures,
* Epilepsy,
* Visual and auditory problems,
* Injection of botulinum toxin in the last 6 months,
* History of surgical operation such as muscle relaxation, tendon extension and selective dorsal rhizotomy in the last 6 months.

Primary outcomes:
measure: Change in functional level from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in spasticity from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in range of motion from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in gross motor functional level from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in postural control from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in functional independence from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in functional balance from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in soft tissue from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in walking from baseline, week 8 and week 16
timeFrame: 16 weeks
measure: Change in body balance change from baseline, week 8 and week 16
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University Institute of Health Sciences
name: Zubeyir Sarı
role: STUDY_DIRECTOR
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