The Effect of Hippotherapy Applied on Different Seating Surfaces in Children With Special Needs

August 8, 2023 updated by: Ebru Sever, Istanbul Medipol University Hospital

The Effect of Hippotherapy Applied on Different Sitting Surfaces on Sitting Balance and Walking Speed in Children With Special Needs

The effect of hippotherapy, which will be applied to children with special needs in a single session, on sitting balance and walking speed under the supervision of a physiotherapist was investigated. 30 randomly selected children with special needs between the ages of 3-18 who were referred to the Gebze Equestrian Training Center were included in the study. The children were randomly divided into 3 groups: 10 in the saddle, 10 naked (direct contact with the horse), and 10 in the hippotherapy group, in which a cloth of different texture was placed on the horse. Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session. It was checked whether the application had an effect on balance and walking speed. Comparisons between the groups were made and it was examined which application was more effective on balance and walking speed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Gebze
      • Kocaeli, Gebze, Turkey, 41400
        • Gebze Municipality Equestrian Training Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a child with special needs between the ages of 3-18,
  • Children with a diagnosis of Cerebral Palsy (CP) have a level of 1 and 2 according to the Gross Motor Function Classification System,
  • Ability to understand simple commands,
  • Ability to sit unaided for at least 10 seconds,

Exclusion Criteria:

  • Presence of clinical conditions that may pose an obstacle
  • Lack of cooperation
  • Presence in another study performed at the same time as the study
  • Lack of family approval.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 (Saddled)
Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.
Other: hippotherapy
Evaluation parameters were applied to 30 children with special needs at the beginning of the session. After the evaluation, each group was given a 30-minute hippotherapy session in the manege area. During the practice, the child simply sat on the horse. The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand. Immediately after the 30-minute application, the initial evaluations were made again. As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
Experimental: Group 2 (Saddleless, direct contact with horse)
Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.
Other: hippotherapy
Evaluation parameters were applied to 30 children with special needs at the beginning of the session. After the evaluation, each group was given a 30-minute hippotherapy session in the manege area. During the practice, the child simply sat on the horse. The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand. Immediately after the 30-minute application, the initial evaluations were made again. As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
Experimental: Group 3 (Different tissue to be put on the saddle)
Bubbled nylon (pat-to-pat) was used as a different texture. Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.
Other: hippotherapy
Evaluation parameters were applied to 30 children with special needs at the beginning of the session. After the evaluation, each group was given a 30-minute hippotherapy session in the manege area. During the practice, the child simply sat on the horse. The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand. Immediately after the 30-minute application, the initial evaluations were made again. As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BeCure Balance Evaluation System
Time Frame: 11 weeks
BeCure Balance Assessment System protocol; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during balancing by sitting on the board for 30 seconds with eyes open, with images.
11 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ten(10) Meter Walking Test(sec)
Time Frame: 11 weeks
In this test, the person is asked to walk at their own normal pace in a pre-measured 10 meter area (if using walking aid, it will be done with it). The time starts when the person's foot is on the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters per second (m/s).
11 weeks
Gross Motor Function Classification System (GMFCS)
Time Frame: 11 weeks
It was used to evaluate the motor functions of participants with a diagnosis of cerebral palsy. It is a standardized method that classifies motor function differences in sitting and walking at 5 levels. If we examine the 5 levels; Level I walks without restrictions; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility is limited and may use a motorized mobility vehicle; Level V is transported in a manual wheelchair.
11 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ebru SEVER, Lecturer, Department of Physiotherapy & Rehabilitation

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BURAKEMİRHAN

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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings