Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Cerebral Palsy

August 13, 2024 updated by: Songül Bağlan Yentür, Firat University

Investigation of the Effect of Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Children With Cerebral Palsy

The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy. The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group. In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Study Overview

Status

Status

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

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.

Detailed Description

Cerebral Palsy can be defined as a non-progressive lesion that occurs in the brain that has not yet completed its development and causes activity limitation with movement and posture problems. Although the disorders seen in Cerebral Palsy are not progressive, these individuals may experience losses in their current motor functions in later ages and this may cause losses in their independence and activities of daily living. The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy. The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group. In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

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 (Estimated)

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.
20

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

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:

  • Being between 6-18 years old
  • Being diagnosed with unilateral spastic type cerebral palsy
  • Voluntariness of the family and individuals to participate in the study
  • Being at I, II, III level according to the Hand Skills Classification System
  • To have the cognitive development to cooperate

Exclusion Criteria:

  • Having undergone any orthopedic and/or neurological surgery and/or BoNT A operation within the last 6 months
  • Having a history of epilepsy
  • Hearing and/or vision loss at a level that prevents participation in the study

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: Hippotherapy group
In addition to conventional physiotherapy, training will be given in the Hippotherapy Simulator for 15 minutes a day, 5 days a week for 4 weeks. The hippotherapy simulator serves a wide range of purposes from recreational use that mimics the movements of a real horse or can make similar movements, to fitness, exercise, sports, education and therapy and is suitable for use by individuals with cerebral palsy.
Other: Hippotherapy group
In addition to conventional physiotherapy, training will be given in the Hippotherapy Simulator for 15 minutes a day, 5 days a week for 4 weeks. The hippotherapy simulator serves a wide range of purposes from recreational use that mimics the movements of a real horse or can make similar movements, to fitness, exercise, sports, education and therapy and is suitable for use by individuals with cerebral palsy.
Experimental: Control group
In addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.
Other: Control group
In addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

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
Hand Function assessment
Time Frame: 2 minutes
Jabson Taylor hand function test will be used. The test measures the accuracy of speed and performance on a variety of grip and release tasks using everyday items.
2 minutes

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
Trunk control assessment
Time Frame: 2 minutes
The Trunk Control Measurement Scale (TCMS) will be used to assess trunk control in the participants. The fifteen-item SCS assesses static and dynamic components of the trunk during sitting.
2 minutes
Balance assessment
Time Frame: 2 minutes
Timed up and go test will be used to evaluate balance. The patient is asked to stand up from the chair without support from the chair, walk 3 m, walk back towards the chair without touching anything and take the sitting position again. The time starts when the patient stands up from the chair and ends when the patient returns to the chair and sits down again.
2 minutes

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.
Firat 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 (Estimated)

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.
August 20, 2024

Primary Completion (Estimated)

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.
October 20, 2024

Study Completion (Estimated)

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.
October 30, 2024

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).
August 13, 2024

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 13, 2024

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, 2024

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, 2024

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 13, 2024

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, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2024/10-03

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.

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