Cerebral Palsy Spastic DiplegiaNCT06047756
Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Cerebral Palsy
A study testing Hippotherapy and Swiss Ball therapy in people with Cerebral Palsy Spastic Diplegia, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare effect in both intervention Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Hippotherapy and Swiss Ball therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 1 Jan 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group 4 to 11 years
- Subject diagnosed with CP
- Mild Spastic Diaplegic of the lower limbs according to the modified ashworth scale grade 1 to 1+
- GMFM scale sitting balance score less than 20
- Medically stable and able to understand commands
Who cannot join
- Epilepsy, other associated neurological disorders, other type of cerebral palsy,
- Attention deficit hyperactivity disorder and sensory issues(poor visual or hearing acuity)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping hand for relief and development
Dīr, Khyberpakhtunkhuwa, 25000
About this study
Official title: Effects of Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Child
To compare effect in both intervention
Read the detailed description
In this study we will compare the effects of hippotherapy and swiss ball therapy. Our objectives of the study are To compare the effects of hippotherapy and Swiss ball training, to improve trunk control and balance on spastic diplegic cerebral palsy
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Hippotherapy, Swiss Ball therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Patient will perform different movement of the trunk while sitting on a horse.
Swiss Ball therapyOther
Patient will perform movements of trunk on swiss ball
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy | Experimental | Patients suffering with diplegic therapy will perform their exercise protocols on a stationary horse.The child is seat astride the horse wearing a helmet and was encouraged to perform various activities designed to emphasize movement in a forward and upward reaching direction to encourage active postural control, trunk strength, balance and trunk/pelvic dissociation.30 minutes to 1 hour with a frequency ranging from 4 sessions per week and the total duration of horseback riding 6 weeks. Receives: Other: Hippotherapy |
| Swiss Ball therapy | Active comparator | Children of second group will receive swiss ball therapy. Position the child to sit on the ball and giving extension rotation and flexion rotation to the child. This will facilitate trunk rotation by which the upper body is towards the weight bearing hip and away from the weight bearing hip.Training program 4 times per weeks with the treatment session of 30 minutes for 6 weeks duration Receives: Other: Swiss Ball therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Functional Scale
Changes from baseline The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy.Greater score means higher functional level
Measured: 6weeks
Trunk Control Measurement Scale
Changes from Baseline The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching
Measured: 6 weeks
Pediatric Balance Scale
Changes from Baseline Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Bashir, MSNMPT, Principal investigator, Riphah international University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047756
- Sponsor's protocol ID
- REC/00123Mehrin Wadood
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2023
- Last updated
- 21 Nov 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Child
- ClinicalTrials.gov ID
- NCT06047756
- Acronym / sponsor ID
- REC/00123Mehrin Wadood
- Conditions
- Cerebral Palsy Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (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.
To compare effect in both intervention
Detailed description
In this study we will compare the effects of hippotherapy and swiss ball therapy. Our objectives of the study are To compare the effects of hippotherapy and Swiss ball training, to improve trunk control and balance on spastic diplegic cerebral palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy | Experimental | Other: HippotherapyPatients suffering with diplegic therapy will perform their exercise protocols on a stationary horse.The child is seat astride the horse wearing a helmet and was encouraged to perform various activities designed to emphasize movement in a forward and upward reaching direction to encourage active postural control, trunk strength, balance and trunk/pelvic dissociation.30 minutes to 1 hour with a frequency ranging from 4 sessions per week and the total duration of horseback riding 6 weeks. |
| Swiss Ball therapy | Active comparator | Other: Swiss Ball therapyChildren of second group will receive swiss ball therapy. Position the child to sit on the ball and giving extension rotation and flexion rotation to the child. This will facilitate trunk rotation by which the upper body is towards the weight bearing hip and away from the weight bearing hip.Training program 4 times per weeks with the treatment session of 30 minutes for 6 weeks duration |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age group 4 to 11 years
- Subject diagnosed with CP
- Mild Spastic Diaplegic of the lower limbs according to the modified ashworth scale grade 1 to 1+
- GMFM scale sitting balance score less than 20
- Medically stable and able to understand commands
Key exclusion criteria (2 listed)
- Epilepsy, other associated neurological disorders, other type of cerebral palsy,
- Attention deficit hyperactivity disorder and sensory issues(poor visual or hearing acuity)
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 |
|---|---|---|
| HippotherapyPatient will perform different movement of the trunk while sitting on a horse. | Other | Hippotherapy |
| Swiss Ball therapyPatient will perform movements of trunk on swiss ball | Other | Swiss Ball therapy |
Primary outcome
Gross Motor Functional Scale
Time frame: 6weeks
Changes from baseline The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy.Greater score means higher functional level
Trunk Control Measurement Scale
Time frame: 6 weeks
Changes from Baseline The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching
Pediatric Balance Scale
Time frame: 6 weeks
Changes from Baseline Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
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 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy Spastic Diplegia
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Not yet recruitingObservational study
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
Cerebral Palsy, Sleep Disorders
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
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.
Ayesha Bashir, MSNMPT principal investigator
Riphah international University Islamabad
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 and Swiss Ball therapy in people with Cerebral Palsy Spastic Diplegia, 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 5 inclusion and 2 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 21 Nov 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 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?
Gross Motor Functional Scale (time frame: 6weeks). The study lists 3 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 21 Nov 2025.