Cerebral PalsyNCT06554171
Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Cerebral Palsy
A study testing Hippotherapy group in people with Cerebral Palsy, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hippotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 30 Oct 2024
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, +904242370000 ext. 8282, songulbaglan23@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Hippotherapy group, Control group
- Keywords
- Cerebral palsy, Hippotherapy smilator, Upper extremity
- 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 groupOther
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy group | Experimental | 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. Receives: Other: Hippotherapy group |
| Control group | Experimental | 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Function assessment
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.
Measured: 2 minutes
Secondary outcomes (2)
Trunk control assessment
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.
Measured: 2 minutes
Balance assessment
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554171
- Sponsor's protocol ID
- 2024/10-03
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06554171
- Acronym / sponsor ID
- 2024/10-03
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Hippotherapy smilator, Upper extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 15 Aug 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy group | Experimental | Other: Hippotherapy groupIn 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. |
| Control group | Experimental | Other: Control groupIn 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 groupIn 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 |
| Control groupIn 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 |
Primary outcome
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 secondary outcomes
Trunk control assessment
Time frame: 2 minutes
Balance assessment
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
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 group in people with Cerebral Palsy, run by Firat 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: status not confirmed, as of the sponsor's last update on 15 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Function assessment (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.