Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy

Marmara University

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Other: Neurodevelopmental Therapy; Other: Hippotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03889262

09.2017.297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Participants in this group will receive only Neurodevelopmental therapy (NDT) based rehabilitation for 45 minutes in each session, twice a week, during 8 weeks, 16 sessions in total. Number of participants in this group is anticipated to be 20.

Treatment:

Other: Neurodevelopmental Therapy

Study Group

Active Comparator group

Description:

After 16 sessions (8 weeks) of only Neurodevelopmental therapy (NDT) based rehabilitation, simulated hippotherapy treatment will be added to rehabilitation program of the same participants. Their NDT treatment will be reduced to 25 minutes whereas hippotherapy will be applied for 20 minutes in each session, 2 sessions a week, 8 weeks in total.

Treatment:

Other: Neurodevelopmental Therapy

Other: Hippotherapy