The Effect of Hippotherapy Simulator in Cerebral Palsy

The Effect of Hippotherapy Simulator on Sitting Balance, Trunk Control and Upper Extremity Skills in Cerebral Palsy

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).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Traditional physiotherapy; Other: Hippotherapy simulator training

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Demet GÖZAÇAN KARABULUT, PhD; Phone Number: +90342 909 75 00; Email: dg.karabulut@gmail.com
• Study Contact Backup: Name: Demet GÖZAÇAN KARABULUT; Phone Number: +90342 909 75 00

Study Locations

• Turkey
  • Gaziantep, Turkey, 27010
    • Gaziantep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hippotherapy simulator training group; 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).	Other: Traditional physiotherapy; Traditional physiotherapy within a specific program; Other: Hippotherapy simulator training; Hippotherapy simulator training will be designed for the individual basis.
Active Comparator: Traditional physiotherapy group; 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).	Other: Traditional physiotherapy; Traditional physiotherapy within a specific program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Baseline
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	At Baseline
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 at 8 weeks
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 at 8 weeks
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 at 8 weeks
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 at 8 weeks
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.	Change from Baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Gaziantep Islam Science and Technology University
• Investigators: Study Director: Demet Gözaçan Karabulut, Gaziantep Islam Science and Technology University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral palsy; Hippotherapy simulator
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: GIBTU-FTR-DGK-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No