The Effect of Hippotherapy Simulator in Children with Spastic Cerebral Palsy

January 13, 2025 updated by: Yalcın KARABULUT, Hasan Kalyoncu University

Investıgatıon of the Effect of Hıppotherapy Sımulator on Lower Extremıty Selectıve Motor Control, Balance and Trunk Control in Chıldren Wıth Spastıc Cerebral Palsy

The horseback riding simulator (HRS) is a dynamic robotic device that mimics the movement of a horse for hippotherapy purposes. HRS aims to improve the patient's balance, adaptation and provide postural adjustment by mimicking the rhythmic movements of the horse.

This study aims to research the potential benefits of the horseback riding simulator on the lower extremity selective motor control, balance and trunk control in children with Cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Between the dates of the study, children with Cerebral palsy (CP) who meet the inclusion criteria will be allocated into two groups (intervention group, control group) by randomiZation method.

Intervention group: horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.

Control group: Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks.

All the assessments will be performed before and after the training in the 8-week groups.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27100
        • Gaziantep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Spastic Cerebral Palsy
  • Voluntary participation
  • Age between 5-17 years,
  • GMFCS Level I-II-III
  • MACS Level I-II-III
  • Modified Asworth Scale (MAS) Level 1-2-3
  • Have the ability to sit with support

Exclusion Criteria:

  • Having severe visual and hearing problems
  • Severe distractibility problems and inability to follow task instructions,
  • Not voluntary to participate in the research,
  • Individuals with CP who have had hip or spine surgery in the last 6 months
  • Individuals with CP who have undergone Botox in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (Horseback riding simulator+Routine physiotherapy)
Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.
Other: Horseback riding simulator
Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation.
Other: Routine Physiotherapy and Rehabilitation
Routine Physiotherapy and Rehabilitation within a spesific programme
Active Comparator: Control group (Routine physiotherapy)
Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks.
Other: Routine Physiotherapy and Rehabilitation
Routine Physiotherapy and Rehabilitation within a spesific programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFCS)
Time Frame: At Baseline
Assessing functional level and gross motor function of children with CP. Level I refers to a child walking independently, while level V refers to mobility with a wheelchair.
At Baseline
Change from Baseline Selective Control Assessment of the Lower Extremity at 8 weeks
Time Frame: Change from Baseline at 8 weeks
Evaluates the lower extremity selective motor control of individuals with CP. The scale assesses five joints separately and bilaterally: hip, knee, ankle, subtalar joint and toe. The degree of selective motor control is determined for each joint as 'normal' (2 points), 'impaired' (1 point) or 'unable to perform' (0 points), according to the patient's ability to perform the movements. The total score is obtained by summing the scores from the joint levels for each limb, with a maximum score of 10 points. Low scores indicate poor selective motor control.
Change from Baseline at 8 weeks
Change from Baseline Pediatric balance scale at 8 weeks
Time Frame: Change from Baseline at 8 weeks
Assesses the balance of children with CP. This scale consists of 14 items, each of which is scored from 0 to 4. A score of 0 indicates that he/she cannot carry out the instruction and a score of 4 indicates that he/she can do it without difficulty. The total score ranges from 0-56. A low total score indicates a decrease in balance function.
Change from Baseline at 8 weeks
Change from Baseline Trunk Control Measurement Scale at 8 weeks
Time Frame: Change from Baseline at 8 weeks
This scale consists of two main parts, dynamic and static sitting balance, and provides an assessment. The scale consists of 15 items. Items are scored as 0, 1, 2 or 3. The minimum score that can be obtained from the scale is 0 and the maximum score is 58. A higher score indicates better trunk control.
Change from Baseline at 8 weeks
Manuel ability classification system (MACS)
Time Frame: At Baseline
Classify how children with CP use their hands when dealing with objects in daily activities. It is a 5-level classification scale. The higher the level, the worse the manual ability. Level 1 means that objects can be handled and used easily and successfully. Level 5 refers to being unable to handle and use objects and having severely limited ability to perform even simple activities.
At Baseline
Change from Baseline Modified Ashworth Scale (MAS) at 8 weeks
Time Frame: Change from Baseline at 8 weeks
This scale is the most widely used clinical scale to assess spasticity. It is a 6-point scale that assesses muscle tone by passively moving the joint through the normal range of possible motion and recording resistance to passive movement. The scoring ranges from 0-5. There is no tonus increase at 0. 5 indicates that the affected limb is rigid. The higher the score, the greater the increase in tonus.
Change from Baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Principal Investigator: Yalçın Karabulut, Hasan Kalyoncu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

November 21, 2024

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 5, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKU-FTR-YK-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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Horseback riding simulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe