Cerebral PalsyNCT05518370
The Effect of Hippotherapy Simulator in Cerebral Palsy
A study testing Hippotherapy simulator training and Traditional physiotherapy in people with Cerebral Palsy, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hippotherapy simulator training and Traditional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Aug 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not voluntary to participate in the research,
- Botox in the last 6 months
- Hip or spine surgeries in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Hippotherapy simulator training, Traditional physiotherapy
- Keywords
- Cerebral palsy, Hippotherapy simulator
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hippotherapy simulator trainingOther
Hippotherapy simulator training will be designed for the individual basis.
Traditional physiotherapyOther
Traditional physiotherapy within a specific program
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy simulator training group | Experimental | 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). Receives: Other: Hippotherapy simulator training; Other: Traditional physiotherapy |
| Traditional physiotherapy group | Active comparator | 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). Receives: Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start26 Aug 2022
- Primary completion10 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet GÖZAÇAN KARABULUT, Gaziantep Islam Science and Technology University
- Investigators
- Demet GÖZAÇAN KARABULUT, Study director, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518370
- Sponsor's protocol ID
- GIBTU-FTR-DGK-1
- Status last verified
- May 2024
- First submitted
- 23 Aug 2022
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gozacan Karabulut D, Numanoglu Akbas A. The effect of horse riding simulator on upper extremity skills, trunk control and functionality in cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2025 Apr;47(7):1725-1732. doi: 10.1080/09638288.2024.2380785. Epub 2024 Jul 18.
PubMed 39022889
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hippotherapy Simulator on Sitting Balance, Trunk Control and Upper Extremity Skills in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05518370
- Acronym / sponsor ID
- GIBTU-FTR-DGK-1
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Hippotherapy simulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy simulator training group | Experimental | Other: Hippotherapy simulator training, Other: Traditional physiotherapyHippotherapy 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 | Active comparator | Other: Traditional physiotherapyTraditional 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). |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Not voluntary to participate in the research,
- Botox in the last 6 months
- Hip or spine surgeries in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hippotherapy simulator trainingHippotherapy simulator training will be designed for the individual basis. | Other | Hippotherapy simulator training group |
| Traditional physiotherapyTraditional physiotherapy within a specific program | Other | Hippotherapy simulator training group, Traditional physiotherapy group |
Primary outcome
Gross Motor Function Classification System (GMFCS)
Time frame: At Baseline
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)
Time frame: At Baseline
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
Time frame: Change from Baseline 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
Time frame: Change from Baseline 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
Time frame: Change from Baseline 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
Time frame: Change from Baseline 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
Time frame: Change from Baseline 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 39022889Gozacan Karabulut D, Numanoglu Akbas A. The effect of horse riding simulator on upper extremity skills, trunk control and functionality in cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2025 Apr;47(7):1725-1732. doi: 10.1080/09638288.2024.2380785. Epub 2024 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demet GÖZAÇAN KARABULUT study director
Gaziantep Islam Science and Technology University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy simulator training and Traditional physiotherapy in people with Cerebral Palsy, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Classification System (GMFCS) (time frame: At Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.