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The Effect of Hippotherapy Simulator in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hippotherapy simulator training
Traditional physiotherapy
Sponsored by
Gaziantep Islam Science and Technology University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Hippotherapy simulator

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Spastic Cerebral Palsy voluntary participation
  • Age between 4-18 years,
  • GMFCS Level I-II-III
  • MACS Level I-II-III
  • Have the ability to sit upright with support

Exclusion Criteria:

  • Not voluntary to participate in the research,
  • Botox in the last 6 months
  • Hip or spine surgeries in the last 6 months

Sites / Locations

  • GaziantepRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hippotherapy simulator training group

Traditional physiotherapy group

Arm Description

Hippotherapy simulator training group will receive a traditional physiotherapy and hippotherapy simulator training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes hippotherapy simulator training).

Traditional physiotherapy group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes).

Outcomes

Primary Outcome Measures

Gross Motor Function Classification System (GMFCS)
Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.
Manuel ability classification system (MACS)
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function
Change from Baseline Gross Motor Function Measure-88 at 8 weeks
It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.
Change from Baseline Trunk Control Measurement Scale at 8 weeks
This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.
Change from Baseline Pediatric Evaluation of Disability Inventory at 8 weeks
The Pediatric Evaluation of Disability Inventory (PEDI) is designed for the functional evaluation of children with special needs. This will be used to evaluate functional ability and performance. 0: can not do, 1: can do in the form of scoring is done. At the end of the evaluation, the points of the related section are collected. Higher score indicates a better level of functional independence.
Change from Baseline ABILHAND-Kids at 8 weeks
Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 21 and the highest score is 63. It can be stated that higher scores correspond to more difficulty in activities.
Change from Baseline The Jebsen Taylor Hand Function Test at 8 weeks
The Jebsen Taylor Hand Function Test (JTHFT) will be used to evaluate hand function in daily life. Both hands are tested separately. The time for all activities is recorded with a stopwatch. Higher duration indicates worse hand function.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
September 12, 2023
Sponsor
Gaziantep Islam Science and Technology University
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1. Study Identification

Unique Protocol Identification Number
NCT05518370
Brief Title
The Effect of Hippotherapy Simulator in Cerebral Palsy
Official Title
The Effect of Hippotherapy Simulator on Sitting Balance, Trunk Control and Upper Extremity Skills in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziantep Islam Science and Technology University

4. Oversight

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

5. Study Description

Brief Summary
Hippotherapy simulators imitate the passive movements of the horse, producing simple movements similar to those of the horse. Hippotherapy simulators are intended to improve sitting balance, postural control and trunk balance. The aim of this study was to research the therapeutic effects of hippotherapy simulator on sitting balance, trunk control and upper extremity skills in individuals with Cerebral Palsy (CP).
Detailed Description
Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS. The eligible participants will be allocated two groups, including hippotherapy simulator training group and traditional physiotherapy control group. All the assessments will be performed before and after the training in the 8-week training groups. The control group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes). Hippotherapy simulator training group will receive a traditional physiotherapy and hippotherapy simulator training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes hippotherapy simulator training). All sessions will be performed in the clinic with the specialist physiotherapist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Hippotherapy simulator

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Hippotherapy simulator training group
Arm Type
Experimental
Arm Description
Hippotherapy simulator training group will receive a traditional physiotherapy and hippotherapy simulator training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes hippotherapy simulator training).
Arm Title
Traditional physiotherapy group
Arm Type
Active Comparator
Arm Description
Traditional physiotherapy group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes).
Intervention Type
Other
Intervention Name(s)
Hippotherapy simulator training
Intervention Description
Hippotherapy simulator training will be designed for the individual basis.
Intervention Type
Other
Intervention Name(s)
Traditional physiotherapy
Intervention Description
Traditional physiotherapy within a specific program
Primary Outcome Measure Information:
Title
Gross Motor Function Classification System (GMFCS)
Description
Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.
Time Frame
At Baseline
Title
Manuel ability classification system (MACS)
Description
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function
Time Frame
At Baseline
Title
Change from Baseline Gross Motor Function Measure-88 at 8 weeks
Description
It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline Trunk Control Measurement Scale at 8 weeks
Description
This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline Pediatric Evaluation of Disability Inventory at 8 weeks
Description
The Pediatric Evaluation of Disability Inventory (PEDI) is designed for the functional evaluation of children with special needs. This will be used to evaluate functional ability and performance. 0: can not do, 1: can do in the form of scoring is done. At the end of the evaluation, the points of the related section are collected. Higher score indicates a better level of functional independence.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline ABILHAND-Kids at 8 weeks
Description
Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 21 and the highest score is 63. It can be stated that higher scores correspond to more difficulty in activities.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline The Jebsen Taylor Hand Function Test at 8 weeks
Description
The Jebsen Taylor Hand Function Test (JTHFT) will be used to evaluate hand function in daily life. Both hands are tested separately. The time for all activities is recorded with a stopwatch. Higher duration indicates worse hand function.
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Spastic Cerebral Palsy voluntary participation Age between 4-18 years, GMFCS Level I-II-III MACS Level I-II-III Have the ability to sit upright with support Exclusion Criteria: Not voluntary to participate in the research, Botox in the last 6 months Hip or spine surgeries in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demet GÖZAÇAN KARABULUT, PhD
Phone
+90342 909 75 00
Email
dg.karabulut@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Demet GÖZAÇAN KARABULUT
Phone
+90342 909 75 00
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demet GÖZAÇAN KARABULUT
Organizational Affiliation
Gaziantep Islam Science and Technology University
Official's Role
Study Director
Facility Information:
Facility Name
Gaziantep
City
Gaziantep
ZIP/Postal Code
27010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demet GÖZAÇAN KARABULUT

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Hippotherapy Simulator in Cerebral Palsy

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