- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06231147
Effects of Horse Riding Simulator With or Without Visual Feedback on Balance and Postural Control
June 11, 2024 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- 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
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
horse riding simulator sessions with mirror visual feedback
|
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
|
|
Other: Group B
horse riding simulator sessions without mirror visual feedback
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
|
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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shehar Bano, MS*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
December 1, 2023
Primary Completion (Actual)
February 5, 2024
Study Completion (Actual)
February 5, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Actual)
January 30, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2024
Last Update Submitted That Met QC Criteria
June 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0765
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.