Cerebral PalsyNCT06231147
Effects of Horse Riding Simulator With or Without Visual Feedback on Balance and Postural Control
A study testing HORSE RIDING SIMULATOR WITH VISUAL FEEDBACK and HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACK in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Spastic cerebral palsy is a neurological condition that causes muscle spasticity and motor impairments, greatly impacting a child's ability to maintain balance and control their posture. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- HORSE RIDING SIMULATOR WITH VISUAL FEEDBACK and HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic cerebral palsy with level I and II according to Gross Motor Function Classification System (GMFCS)
- Age between 8 and 12 years
- Ability to sit and stand independently
- Both genders are included (female and male)
Who cannot join
- Having received an injection of botulinum toxin within 3 months
- Having undergone orthopedic surgery or selective dorsal rhizotomy in the previous 1 year
- Having undergone HRS training within 6 months;
- Having severe pain, joint dislocation, contracture, or spinal deformity
- Having experienced uncontrolled epileptic seizure
- Having poor visual or hearing acuity.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Horse Riding Simulator With or Without Visual Feedback on Balance and Postural Control in Children With Spastic Cerebral Palsy
Spastic cerebral palsy is a neurological condition that causes muscle spasticity and motor impairments, greatly impacting a child's ability to maintain balance and control their posture. The horse riding simulator (HRS), inspired by hippo therapy, has emerged as a potential therapeutic intervention for enhancing motor function in individuals with cerebral palsy. This study explored the additional effects of mirror visual feedback when used in conjunction with the HRS. Strategically placed mirrors allow participants to observe their own body movements and positions in real-time. The simulator's rhythmic, multidimensional movements deliver sensory input and challenge the motor system, promoting postural adjustments and improved balance. Furthermore, the integration of mirror visual feedback appears to enhance the therapeutic benefits. Real-time visual information enables children to actively observe and correct their body positioning, leading to improved body awareness and more efficient motor responses.
Read the detailed description
Cerebral palsy (CP), one of the most common physical disabilities in childhood, is a disorder of movement and posture caused by non-progressive lesions in the developing brain. Children with CP, to varying degrees, have muscle weakness, tone abnormality, and motor-control impairment, causing abnormal posture and poor balance control.In high-income countries, the current birth prevalence of cerebral palsy has decreased to 1.6 per 1000 live births. However, in low- and middle-income countries, the birth prevalence is significantly higher. Children diagnosed with CP exhibit a range of muscle weakness, tone abnormalities, and impaired motor control. These factors contribute to abnormal posture and compromised control over balance
- Conditions
- Cerebral Palsy
- Being tested
- HORSE RIDING SIMULATOR WITH VISUAL FEEDBACK, HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACK
- Keywords
- Balance, Cerebral Palsy, Horse Riding Simulator (HRS), Posture Control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HORSE RIDING SIMULATOR WITH VISUAL FEEDBACKOther
horse riding simulator session with mirror visual feedback. The participants will be instructed that how to perform exercises by using the horse riding simulator (HRS) system in front of mirror
HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACKOther
horse riding simulator session without visual feedback. The participants will be instructed that how to perform exercises by using the horse riding simulator (HRS) system.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | horse riding simulator sessions with mirror visual feedback Receives: Other: HORSE RIDING SIMULATOR WITH VISUAL FEEDBACK |
| Group B | Other | horse riding simulator sessions without mirror visual feedback Receives: Other: HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric balance scale
The Pediatric Balance Scale is assessment tool specifically designed to evaluate balance in children. It has been extensively used in clinical and research settings to assess balance impairments and monitor progress over time.
Measured: 8 weeks
Posture and postural ability scale
Posture and Postural Ability Scale is an assessment tool that allows for posture and postural ability to be assessed independently
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shehar Bano, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231147
- Sponsor's protocol ID
- REC/RCR&AHS/23/0765
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung YG, Chang HJ, Jo ES, Kim DH. The Effect of a Horse-Riding Simulator with Virtual Reality on Gross Motor Function and Body Composition of Children with Cerebral Palsy: Preliminary Study. Sensors (Basel). 2022 Apr 10;22(8):2903. doi: 10.3390/s22082903.
PubMed 35458888
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Horse Riding Simulator With or Without Visual Feedback on Balance and Postural Control in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06231147
- Acronym / sponsor ID
- REC/RCR&AHS/23/0765
- Conditions
- Cerebral Palsy
- Keywords
- Balance, Cerebral Palsy, Horse Riding Simulator (HRS), Posture Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 30 Jan 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.
Spastic cerebral palsy is a neurological condition that causes muscle spasticity and motor impairments, greatly impacting a child's ability to maintain balance and control their posture. The horse riding simulator (HRS), inspired by hippo therapy, has emerged as a potential therapeutic intervention for enhancing motor function in individuals with cerebral palsy. This study explored the additional effects of mirror visual feedback when used in conjunction with the HRS. Strategically placed mirrors allow participants to observe their own body movements and positions in real-time. The simulator's rhythmic, multidimensional movements deliver sensory input and challenge the motor system, promoting postural adjustments and improved balance. Furthermore, the integration of mirror visual feedback appears to enhance the therapeutic benefits. Real-time visual information enables children to actively observe and correct their body positioning, leading to improved body awareness and more efficient motor responses.
Detailed description
Cerebral palsy (CP), one of the most common physical disabilities in childhood, is a disorder of movement and posture caused by non-progressive lesions in the developing brain. Children with CP, to varying degrees, have muscle weakness, tone abnormality, and motor-control impairment, causing abnormal posture and poor balance control.In high-income countries, the current birth prevalence of cerebral palsy has decreased to 1.6 per 1000 live births. However, in low- and middle-income countries, the birth prevalence is significantly higher. Children diagnosed with CP exhibit a range of muscle weakness, tone abnormalities, and impaired motor control. These factors contribute to abnormal posture and compromised control over balance
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: HORSE RIDING SIMULATOR WITH VISUAL FEEDBACKhorse riding simulator sessions with mirror visual feedback |
| Group B | Other | Other: HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACKhorse riding simulator sessions without mirror visual feedback |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Spastic cerebral palsy with level I and II according to Gross Motor Function Classification System (GMFCS)
- Age between 8 and 12 years
- Ability to sit and stand independently
- Both genders are included (female and male)
Key exclusion criteria (6 listed)
- Having received an injection of botulinum toxin within 3 months
- Having undergone orthopedic surgery or selective dorsal rhizotomy in the previous 1 year
- Having undergone HRS training within 6 months;
- Having severe pain, joint dislocation, contracture, or spinal deformity
- Having experienced uncontrolled epileptic seizure
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 |
|---|---|---|
| HORSE RIDING SIMULATOR WITH VISUAL FEEDBACKhorse riding simulator session with mirror visual feedback. The participants will be instructed that how to perform exercises by using the horse riding simulator (HRS) system in front of mirror | Other | Group A |
| HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACKhorse riding simulator session without visual feedback. The participants will be instructed that how to perform exercises by using the horse riding simulator (HRS) system. | Other | Group B |
Primary outcome
Pediatric balance scale
Time frame: 8 weeks
The Pediatric Balance Scale is assessment tool specifically designed to evaluate balance in children. It has been extensively used in clinical and research settings to assess balance impairments and monitor progress over time.
Posture and postural ability scale
Time frame: 8 weeks
Posture and Postural Ability Scale is an assessment tool that allows for posture and postural ability to be assessed independently
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 13 Jun 2024.
- Background: PubMed 35458888Jung YG, Chang HJ, Jo ES, Kim DH. The Effect of a Horse-Riding Simulator with Virtual Reality on Gross Motor Function and Body Composition of Children with Cerebral Palsy: Preliminary Study. Sensors (Basel). 2022 Apr 10;22(8):2903. doi: 10.3390/s22082903.
- 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.
Shehar Bano, MS* principal investigator
Riphah International 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 HORSE RIDING SIMULATOR WITH VISUAL FEEDBACK and HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACK in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 6 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 13 Jun 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 Pakistan. 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?
Pediatric balance scale (time frame: 8 weeks). The study lists 2 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 NCT06231147, 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 13 Jun 2024.