Cerebral PalsyNCT06404827
The Effect of Hippotherapy Simulator in Children with Spastic Cerebral Palsy
A study testing Horseback riding simulator and Routine Physiotherapy and Rehabilitation in people with Cerebral Palsy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Horseback riding simulator and Routine Physiotherapy and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2024to 21 Nov 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Horseback riding simulator, Routine Physiotherapy and Rehabilitation
- Keywords
- Cerebral Palsy, Horseback riding simulator, Selective motor control, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horseback riding simulatorOther
Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation.
Routine Physiotherapy and RehabilitationOther
Routine Physiotherapy and Rehabilitation within a spesific programme
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Horseback riding simulator+Routine physiotherapy) | Experimental | 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. Receives: Other: Horseback riding simulator; Other: Routine Physiotherapy and Rehabilitation |
| Control group (Routine physiotherapy) | Active comparator | Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks. Receives: Other: Routine Physiotherapy and Rehabilitation |
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 gross motor function of children with CP. Level I refers to a child walking independently, while level V refers to mobility with a wheelchair.
Measured: At Baseline
Manuel ability classification system (MACS)
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.
Measured: At Baseline
Change from Baseline Selective Control Assessment of the Lower Extremity 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.
Measured: Change from Baseline at 8 weeks
Change from Baseline Pediatric balance scale 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.
Measured: Change from Baseline at 8 weeks
Change from Baseline Trunk Control Measurement Scale 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.
Measured: Change from Baseline at 8 weeks
Change from Baseline Modified Ashworth Scale (MAS) 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.
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 posted8 May 2024
- Study start20 Feb 2024
- Primary completion20 Nov 2024
- Study completion21 Nov 2024
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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yalcın KARABULUT, Hasan Kalyoncu University
- Investigators
- Yalçın Karabulut, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404827
- Sponsor's protocol ID
- HKU-FTR-YK-1
- Status last verified
- Feb 2024
- First submitted
- 5 May 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıon of the Effect of Hıppotherapy Sımulator on Lower Extremıty Selectıve Motor Control, Balance and Trunk Control in Chıldren Wıth Spastıc Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06404827
- Acronym / sponsor ID
- HKU-FTR-YK-1
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Horseback riding simulator, Selective motor control, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 8 May 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Horseback riding simulator+Routine physiotherapy) | Experimental | Other: Horseback riding simulator, Other: Routine Physiotherapy and RehabilitationHorseback 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) | Active comparator | Other: Routine Physiotherapy and RehabilitationRoutine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of Spastic Cerebral Palsy
- Voluntary participation
- Age between 5-17 years,
- GMFCS Level I-II-III
- MACS Level I-II-III
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Horseback riding simulatorHorseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. | Other | Intervention group (Horseback riding simulator+Routine physiotherapy) |
| Routine Physiotherapy and RehabilitationRoutine Physiotherapy and Rehabilitation within a spesific programme | Other | Control group (Routine physiotherapy), Intervention group (Horseback riding simulator+Routine physiotherapy) |
Primary outcome
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.
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.
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 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 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 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.
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 15 Jan 2025.
- 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.
Yalçın Karabulut principal investigator
Hasan Kalyoncu 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 Horseback riding simulator and Routine Physiotherapy and Rehabilitation in people with Cerebral Palsy, run by Hasan Kalyoncu 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 7 inclusion and 5 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 15 Jan 2025. 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 6 primary outcomes in all. 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 Jan 2025.