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Hippotherapy Simulator in Children With Cerebral Palsy

Primary Purpose

Rehabilitation, Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neurodevelopmental Therapy
Hippotherapy Simulator
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation focused on measuring Cerebral Palsy, Hippotherapy, Postural Balance, Gait, Postural Control

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Özdel Dilbade Özel Eğitim ve Rehabilitasyon Merkezi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neurodevelopmental Therapy Group

Hippotherapy Simulator Group

Arm Description

The number of participants in this group is 30. All participants were included in the rehabilitation program using only the Neurodevelopmental Therapy approach for 16 sessions (8 weeks x 2 days x 45 minutes).

The same participants were taken into a rehabilitation program in which 16 sessions (8 weeks x 2 days a week) the Hippotherapy Simulator device (30 minutes) and Neurodevelopmental Therapy (NDT) (15 minutes) (HS + NDT method) were used together.

Outcomes

Primary Outcome Measures

Gross Motor Function Classification System (GMFSS)
Functional levels of participants were determined with the "Gross Motor Function Classification System" (GMFSS) before treatment. It is a system that classifies the gross motor functions of children with cerebral palsy. It classifies gross motor functions into five levels.
Change in gross motor function from baseline to week 8 to week 16
The gross motor functions of the participants were evaluated using Gross Motor Function Measure-88 (GMFM-88) before treatment, in the 8th week and the 16th week. It is a valid and reliable assessment tool widely used to evaluate motor functions in children with cerebral palsy. It consists of 88 items and includes 5 subsections: (A) lying and Rolling; (B) sitting; (C) crawling and kneeling; (D) standing; (E) walking, running and jumping.
Change in range of motion from baseline to week 8 to week 16
The range of motion of the joints in the lower extremities was measured using the universal goniometer before treatment, in the 8th week and the 16th week.
Change in spasticity from baseline to week 8 to week 16
Muscle spasticity of the lower limbs was evaluated with Modified Ashworth Scale (MAS) before treatment, in the 8th week and the 16th week. In the evaluations made with MAS, the muscle tone is rated between "0" and "4". "0" indicates that there is no increase in muscle tone, and "4" indicates that the affected part is rigid in flexion and extension.
Change in muscle tones of lower extremities from baseline to week 8 to week 16
The tone, stiffness, and flexibility of the lower limb muscles were evaluated with the Myoton®PRO Digital Palpation Device before treatment, in the 8th week and the 16th week. It is an evidence-based Class 1 device (MDD Annex IX) that evaluates the biomechanical properties of soft biological tissues non-invasively, objectively, reliably, cheaply, quickly and easily.
Change in trunk postural control from baseline to week 8 to week 16
The functional strength of the trunk, postural control and quality of trunk movements were evaluated with The Trunk Impairment Scale (TIS) before treatment, in the 8th week and the 16th week. TIS has been developed to evaluate the trunk of individuals with stroke and is a scale that has been adapted for use with children with cerebral palsy. TIS evaluates the body functionally in terms of strength in the sitting position. In addition, it evaluates the relationship between the body part and function by evaluating the body's static and dynamic balances and body coordination. It consists of three subsections: static, dynamic and coordination.
Change in dynamic and functional balance from baseline to week 8 to week 16.
The dynamic and functional balances of the participants were evaluated with The Pediatric Balance Scale (PBS) before treatment, in the 8th week and the 16th week. PBS is an assessment tool adapted from the Berg Balance Scale (BDS) to evaluate children's functional balance in daily life activities. The scale consists of 14 sections and each section is scored between 0 and 4; the highest score that can be obtained from the scale is 56.
Change in dynamic balance in sitting and standing positions from baseline to week 8 to week 16
Pedalo® Sensamove Balance Test Pro (Holz-Hoerz Gesellschaft mit beschränkter Haftung (GmbH), Germany) Software with miniboard was used to evaluate the dynamic balance functions of the participants during their sitting, standing position at the beginning, at the 8th and at the 16th week. This device has been developed to record the movements of the user in order to learn about the balance, response time and possible imbalances of the body.
The Functional Independence Measure (WeeFIM)
The functional independence of children in daily activities was assessed with The Functional Independence Measure (WeeFIM) initially, at week 8 and at week 16. WeeFIM consists of 6 parts: self-care, sphincter control, mobility, locomotion, communication, and social communication, and a total of 18 activities are questioned. It is scored from 1 to 7 according to whether it receives help, performs on time or whether an auxiliary device is required when performing the function in each item.
Change in walking functions from baseline to week 8 to week 16
Win-Track (Medicapteurs, France) path and software system was used to evaluate the walking functions (Spatio-temporal parameters) of participants at the beginning, in the 8th and the 16th week. Win-Track; static, posturography and gait analysis is a foot pressure-sensitive walking path that provides complete freedom in posture and movement acquisition. It records foot pressure up to 200 images per second during standing, walking or certain activities (such as sports movements, postural sequences) through 12.288 sensors on the Win-Track, which is in the form of a one-piece platform.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2020
Last Updated
May 7, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04378036
Brief Title
Hippotherapy Simulator in Children With Cerebral Palsy
Official Title
The Effects of a Hippotherapy Simulator in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
October 28, 2017 (Actual)
Study Completion Date
October 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Cerebral Palsy, Spastic
Keywords
Cerebral Palsy, Hippotherapy, Postural Balance, Gait, Postural Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodevelopmental Therapy Group
Arm Type
Active Comparator
Arm Description
The number of participants in this group is 30. All participants were included in the rehabilitation program using only the Neurodevelopmental Therapy approach for 16 sessions (8 weeks x 2 days x 45 minutes).
Arm Title
Hippotherapy Simulator Group
Arm Type
Active Comparator
Arm Description
The same participants were taken into a rehabilitation program in which 16 sessions (8 weeks x 2 days a week) the Hippotherapy Simulator device (30 minutes) and Neurodevelopmental Therapy (NDT) (15 minutes) (HS + NDT method) were used together.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Therapy
Intervention Description
The Neurodevelopmental Therapy rehabilitation program was determined according to the children's level of gross motor function, age, gender, mental state, and preferences. Neurodevelopmental Therapy program consists of the rehabilitation of muscle tone disorders, increasing sensory-perception-motor integrity, exercises to increase limb functions and body control, stretching and strengthening exercises for muscle shortness and weakness, exercises that include movements in daily life and training activities such as standing, walking, body care.
Intervention Type
Device
Intervention Name(s)
Hippotherapy Simulator
Intervention Description
Horse Riding Simulator (HRS) device was used as a hippotherapy simulator device. HRS is a device that moves forward, backward, backward-to-back, right-to-left swing and up-and-down swing in 3 dimensions, similar to the movements of a real horse, forming an 8-shaped movement on five axes. After the children sat in the saddle section, they were first taken to the warm-up speed program for 5 minutes, then to another one of the other speed levels (gradually moved to other speed levels as appropriate for the development and tolerance of children) and finally to the warm-up speed program for 5 minutes.
Primary Outcome Measure Information:
Title
Gross Motor Function Classification System (GMFSS)
Description
Functional levels of participants were determined with the "Gross Motor Function Classification System" (GMFSS) before treatment. It is a system that classifies the gross motor functions of children with cerebral palsy. It classifies gross motor functions into five levels.
Time Frame
Baseline
Title
Change in gross motor function from baseline to week 8 to week 16
Description
The gross motor functions of the participants were evaluated using Gross Motor Function Measure-88 (GMFM-88) before treatment, in the 8th week and the 16th week. It is a valid and reliable assessment tool widely used to evaluate motor functions in children with cerebral palsy. It consists of 88 items and includes 5 subsections: (A) lying and Rolling; (B) sitting; (C) crawling and kneeling; (D) standing; (E) walking, running and jumping.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in range of motion from baseline to week 8 to week 16
Description
The range of motion of the joints in the lower extremities was measured using the universal goniometer before treatment, in the 8th week and the 16th week.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in spasticity from baseline to week 8 to week 16
Description
Muscle spasticity of the lower limbs was evaluated with Modified Ashworth Scale (MAS) before treatment, in the 8th week and the 16th week. In the evaluations made with MAS, the muscle tone is rated between "0" and "4". "0" indicates that there is no increase in muscle tone, and "4" indicates that the affected part is rigid in flexion and extension.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in muscle tones of lower extremities from baseline to week 8 to week 16
Description
The tone, stiffness, and flexibility of the lower limb muscles were evaluated with the Myoton®PRO Digital Palpation Device before treatment, in the 8th week and the 16th week. It is an evidence-based Class 1 device (MDD Annex IX) that evaluates the biomechanical properties of soft biological tissues non-invasively, objectively, reliably, cheaply, quickly and easily.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in trunk postural control from baseline to week 8 to week 16
Description
The functional strength of the trunk, postural control and quality of trunk movements were evaluated with The Trunk Impairment Scale (TIS) before treatment, in the 8th week and the 16th week. TIS has been developed to evaluate the trunk of individuals with stroke and is a scale that has been adapted for use with children with cerebral palsy. TIS evaluates the body functionally in terms of strength in the sitting position. In addition, it evaluates the relationship between the body part and function by evaluating the body's static and dynamic balances and body coordination. It consists of three subsections: static, dynamic and coordination.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in dynamic and functional balance from baseline to week 8 to week 16.
Description
The dynamic and functional balances of the participants were evaluated with The Pediatric Balance Scale (PBS) before treatment, in the 8th week and the 16th week. PBS is an assessment tool adapted from the Berg Balance Scale (BDS) to evaluate children's functional balance in daily life activities. The scale consists of 14 sections and each section is scored between 0 and 4; the highest score that can be obtained from the scale is 56.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in dynamic balance in sitting and standing positions from baseline to week 8 to week 16
Description
Pedalo® Sensamove Balance Test Pro (Holz-Hoerz Gesellschaft mit beschränkter Haftung (GmbH), Germany) Software with miniboard was used to evaluate the dynamic balance functions of the participants during their sitting, standing position at the beginning, at the 8th and at the 16th week. This device has been developed to record the movements of the user in order to learn about the balance, response time and possible imbalances of the body.
Time Frame
baseline, 8th. week, 16th. week
Title
The Functional Independence Measure (WeeFIM)
Description
The functional independence of children in daily activities was assessed with The Functional Independence Measure (WeeFIM) initially, at week 8 and at week 16. WeeFIM consists of 6 parts: self-care, sphincter control, mobility, locomotion, communication, and social communication, and a total of 18 activities are questioned. It is scored from 1 to 7 according to whether it receives help, performs on time or whether an auxiliary device is required when performing the function in each item.
Time Frame
baseline, 8th. week, 16th. week
Title
Change in walking functions from baseline to week 8 to week 16
Description
Win-Track (Medicapteurs, France) path and software system was used to evaluate the walking functions (Spatio-temporal parameters) of participants at the beginning, in the 8th and the 16th week. Win-Track; static, posturography and gait analysis is a foot pressure-sensitive walking path that provides complete freedom in posture and movement acquisition. It records foot pressure up to 200 images per second during standing, walking or certain activities (such as sports movements, postural sequences) through 12.288 sensors on the Win-Track, which is in the form of a one-piece platform.
Time Frame
baseline, 8th. week, 16th. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan GÜNAY YAZICI, PhD(c)
Organizational Affiliation
Marmara University Institute of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zübeyir SARI, Assoc Prof
Organizational Affiliation
Marmara University Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Özdel Dilbade Özel Eğitim ve Rehabilitasyon Merkezi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Hippotherapy Simulator in Children With Cerebral Palsy

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