Clinical trial NCT04378036: Hippotherapy Simulator in Children With Cerebral Palsy
Official title: The Effects of a Hippotherapy Simulator in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Cerebral Palsy, Spastic
Keywords: Cerebral Palsy
Hippotherapy
Postural Balance
Gait
Postural Control
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different treatment methods were applied to the participants (n=30). Rehabilitation programs based on individual Neurodevelopmental Therapy were applied to the participants included in the study for eight weeks (first group). In the next eight weeks, the Hippotherapy Simulator system was applied to the same participants in addition to individual Neurodevelopmental Therapy-based rehabilitation programs (study group).
Primary purpose: TREATMENT

Brief summary: The aim of this study was to research the effects of hippotherapy simulator in children with Cerebral Palsy. In order to evaluate its effectiveness, assessment of gross motor functions, lower extremity functions, muscle tone and spasticity, trunk control, sitting and standing balance, walking functions and functional independence were being applied.

Detailed description: "Cerebral Palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that is attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain." The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior, by epilepsy, and by secondary musculoskeletal problems.

CP is the most common neurodevelopmental disorder that begins in early childhood, continues for life and causes physical impairment. Damage occurring in the developing brain results in voluntary movement, postural and motor control disorders, balance problems and gait disorders.

Hippotherapy is used effectively in increasing the participation of children with CP by improving their balance, motor function, posture and mobility and improving their quality of life. Although hippotherapy has many physical, functional, emotional and social benefits for children with CP, it also has some disadvantages that limit its use in the treatment of these children. There are risks such as serious injuries caused by children being afraid of a horse, falling from a horse or kicking a horse, increased hypertonicity due to fear and stress on the horse and exposure to allergic reactions due to environmental antigens. In order to overcome these conditions and reach more patients, hippotherapy simulator systems, which have been increasing rapidly in recent years, have been developed.

Hippotherapy simulators are systems that mimic the walking and movements of a real horse. As they are a newly developed system, studies investigating their effectiveness, especially in children with CP, are very limited. The aim of this study is to research the effects of hippotherapy simulator on gross motor functions, lower extremity functions, muscle tone and spasticity, trunk control, sitting and standing balance, walking functions and functional independence in children with Cerebral Palsy.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of Spastic Cerebral Palsy
* Children aged between 5 - 18 years
* GMFCS level is I, II or III
* Independent seating
* Walking with at least 10 meters of independent, orthotic and/or auxiliary device
* Can understand simple verbal instruction
* Those with hip adductor muscle spasticity level less than 2 according to MAS
* Having bilateral passive hip abduction enough to could sit into the hippotherapy simulator device
* Voluntarily agreed to participate in the study

Exclusion Criteria:

* Those with hip dislocation
* Severe contracture or deformity to prevent the study
* Advanced scoliosis (above 20 degrees)
* Acute uncontrolled acute seizures
* Uncontrollable severe epileptic attacks
* Visual and auditory problems
* Injection of botulinum toxin in the last 6 months patients
* Underwent surgical operation such as muscle relaxation, tendon extension, and selective dorsal rhizotomy in the last 6 months

Primary outcomes:
measure: Gross Motor Function Classification System (GMFSS)
timeFrame: Baseline
measure: Change in gross motor function from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
measure: Change in range of motion from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
measure: Change in spasticity from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
measure: Change in muscle tones of lower extremities from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
measure: Change in trunk postural control from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
measure: Change in dynamic and functional balance from baseline to week 8 to week 16.
timeFrame: baseline, 8th. week, 16th. week
measure: Change in dynamic balance in sitting and standing positions from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
measure: The Functional Independence Measure (WeeFIM)
timeFrame: baseline, 8th. week, 16th. week
measure: Change in walking functions from baseline to week 8 to week 16
timeFrame: baseline, 8th. week, 16th. week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Özdel Dilbade Özel Eğitim ve Rehabilitasyon Merkezi
Study officials:
affiliation: Marmara University Institute of Health Sciences
name: Canan GÜNAY YAZICI, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University Faculty of Health Sciences
name: Zübeyir SARI, Assoc Prof
role: STUDY_DIRECTOR
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