Cerebral Palsy (CP)HYPPOTER25NCT07134582
Trial Examines Short-term Effects of Hippotherapy on Fascia Properties and Quality of Life in Children With CP.
A study testing Hippotherapy 1x/week and Hippotherapy 2x/week in people with Cerebral Palsy (CP) and Rehabilitation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The effects of hippotherapy on gross motor function, balance, and spasticity in children with cerebral palsy (CP) are well-documented, but its impact on the thoracolumbar fascia (TLF) remains unexplored area to date. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Rehabilitation, Motor Coordination or Function
- What is being tested?
- Hippotherapy 1x/week and Hippotherapy 2x/week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSlovenia
- Study dates
- Sep 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- classified as level II or III according to the GMFCS, and who, according to the assessment of a specialist physician, are indicated for hippotherapy aged between 4 and 12 years
- who are undergoing neurophysiotherapeutic treatment
- who have not undergone orthopedic surgery in the last six months and do not have uncontrolled epilepsy
- are willing to be randomly assigned to any group (or whose parents/caregiver's consent)
- understand instructions in Slovene and are willing to participate in the study for four weeks (or whose parents/ caregiver's consent)
- without skin diseases, scars, or wounds on the examined part of the back
Who cannot join
- who have previously participated in a hippotherapy program
- with a known and diagnosed psychiatric disorder for which hippotherapy is contraindicated
- with limitations due to hearing or visual impairment
- with painful adductor contractures, painful subluxation, or hip dislocation are not willing to be randomly assigned to any group (or whose parents/caregiver's consent)
- who are afraid of horses or have an allergy to horsehair
- with skin diseases, scars, or wounds on the examined part of the back
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
Konjeniški zavod Epona
Novo Mesto, Dolenjska, 8000
Sabina Devjak Novak, Phd, +38640294213, sabina.d.novak@gmail.com
About this study
Official title: The Effects of Hippotherapy on Viscoelastic Properties of Thoracolumbar Fascia and Quality of Life in Children With Spastic Cerebral Palsy and Their Parents/Caregivers
The effects of hippotherapy on gross motor function, balance, and spasticity in children with cerebral palsy (CP) are well-documented, but its impact on the thoracolumbar fascia (TLF) remains unexplored area to date. This research protocol aims to investigate the short-term effects of hippotherapy on the viscoelastic and biomechanical properties of the TLF and quality of life (QoL) in children with spastic CP and their parents/caregivers. A 4-week randomized control trial will compare the effects of once-weekly and twice-weekly hippotherapy sessions to a control group without intervention. The study will assess the viscoelastic and biomechanical properties of the TLF using the MyotonPRO device in children with spastic CP aged 4-12 years. Myotonometer parameters, including oscillation frequency, stiffness, logarithmic decrement, stress relaxation, and creep, will be analyzed before, during, and after the intervention. Functional tests, such as the 10-meter walk test (comfortable and fast walking), cadence, one-leg stance test (eyes open and closed), and functional reach test (forward and lateral), will also be monitored. QoL will be assessed using the CP QOL-Child questionnaire. The primary outcomes will include changes in myotonometer parameters, their correlation with functional tests, and differences between intervention groups. Secondary outcomes will explore whether hippotherapy impacts QoL and the relationship between QoL domains and TLF properties. Results will evaluate whether twice-weekly therapy yields statistically significant differences in the specified parameters compared once-weekly sessions and contribute to understanding hippotherapy's mechanisms, supporting more individualized therapies to improve QoL for children with CP and their families.
- Conditions
- Cerebral Palsy (CP), Rehabilitation, Motor Coordination or Function, Hippotherapy, Fascia, Quality of Life
- Being tested
- Hippotherapy 1x/week, Hippotherapy 2x/week
- 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 1x/weekOther
This group will perform hippotherapy once per week for 12 weeks
Hippotherapy 2x/weekOther
This group will perform hippotherapy twice per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy 1x/week | Experimental | Not described Receives: Other: Hippotherapy 1x/week |
| Hippotherapy 2x/week | Experimental | Not described Receives: Other: Hippotherapy 2x/week |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viscoelastic properties in TLF (5 measurable parameters)
- oscillation frequency (F)-Hz
- dynamic stiffness (S)-N/m
- oscillation decrement (D)-arb
- mechanical stress relaxation time (R)-ms (milliseconds)
- creep (C)-arb
Measured: 1. baseline (before hippotherapy starts): all groups 2. in 2 weeks (midway through the therapy): all groups 3. in 4 weeks (at the end of hippotherapy): all groups 4. one day after the completion of the 4-week hippotherapy: only experimental groups
Functional tests (7 measurable parameters)
- 10-meter walk test (comfortable walking)-10 m/time spent in seconds
- 10-meter walk test ( fast walking)-10 m/time spent in seconds
- cadence (steps/minute)
- a one-leg stance test with eyes open-seconds
- a one-leg stance test with eyes closed-seconds
- functional reach test forward-centimetres
- functional reach test lateral-centimetres
Measured: 1. baseline (before hippotherapy starts): all groups 2. in 2 weeks (midway through the therapy): all groups 3. in 4 weeks (at the end of hippotherapy): all groups 4. one day after the completion of the 4-week hippotherapy: only experimental groups
Secondary outcomes (1)
Quality of life of children and Quality of live of their parents/caregivers
CP QOL-Child questionnaire (version for children) to children aged between 9 and 12 years in both experimental groups.
CP QOL-Child questionnaire (version for parents) to the parents/caregivers of all children in both experimental groups.
Measured: 1. baseline (before hippotherapy starts) 2. in 4 weeks (at the end of hippotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134582
- Sponsor's protocol ID
- HYPPOTER25
- Acronym
- HYPPOTER25
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 21 Aug 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hippotherapy on Viscoelastic Properties of Thoracolumbar Fascia and Quality of Life in Children With Spastic Cerebral Palsy and Their Parents/Caregivers
- ClinicalTrials.gov ID
- NCT07134582
- Acronym / sponsor ID
- HYPPOTER25 / HYPPOTER25
- Conditions
- Cerebral Palsy (CP), Rehabilitation, Motor Coordination or Function, Hippotherapy, Fascia, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Aug 2025 (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 effects of hippotherapy on gross motor function, balance, and spasticity in children with cerebral palsy (CP) are well-documented, but its impact on the thoracolumbar fascia (TLF) remains unexplored area to date. This research protocol aims to investigate the short-term effects of hippotherapy on the viscoelastic and biomechanical properties of the TLF and quality of life (QoL) in children with spastic CP and their parents/caregivers. A 4-week randomized control trial will compare the effects of once-weekly and twice-weekly hippotherapy sessions to a control group without intervention. The study will assess the viscoelastic and biomechanical properties of the TLF using the MyotonPRO device in children with spastic CP aged 4-12 years. Myotonometer parameters, including oscillation frequency, stiffness, logarithmic decrement, stress relaxation, and creep, will be analyzed before, during, and after the intervention. Functional tests, such as the 10-meter walk test (comfortable and fast walking), cadence, one-leg stance test (eyes open and closed), and functional reach test (forward and lateral), will also be monitored. QoL will be assessed using the CP QOL-Child questionnaire. The primary outcomes will include changes in myotonometer parameters, their correlation with functional tests, and differences between intervention groups. Secondary outcomes will explore whether hippotherapy impacts QoL and the relationship between QoL domains and TLF properties. Results will evaluate whether twice-weekly therapy yields statistically significant differences in the specified parameters compared once-weekly sessions and contribute to understanding hippotherapy's mechanisms, supporting more individualized therapies to improve QoL for children with CP and their families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy 1x/week | Experimental | Other: Hippotherapy 1x/week |
| Hippotherapy 2x/week | Experimental | Other: Hippotherapy 2x/week |
| Control | No intervention | – |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- classified as level II or III according to the GMFCS, and who, according to the assessment of a specialist physician, are indicated for hippotherapy aged between 4 and 12 years
- who are undergoing neurophysiotherapeutic treatment
- who have not undergone orthopedic surgery in the last six months and do not have uncontrolled epilepsy
- are willing to be randomly assigned to any group (or whose parents/caregiver's consent)
- understand instructions in Slovene and are willing to participate in the study for four weeks (or whose parents/ caregiver's consent)
Key exclusion criteria (6 listed)
- who have previously participated in a hippotherapy program
- with a known and diagnosed psychiatric disorder for which hippotherapy is contraindicated
- with limitations due to hearing or visual impairment
- with painful adductor contractures, painful subluxation, or hip dislocation are not willing to be randomly assigned to any group (or whose parents/caregiver's consent)
- who are afraid of horses or have an allergy to horsehair
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 1x/weekThis group will perform hippotherapy once per week for 12 weeks | Other | Hippotherapy 1x/week |
| Hippotherapy 2x/weekThis group will perform hippotherapy twice per week for 12 weeks | Other | Hippotherapy 2x/week |
Primary outcome
Change in viscoelastic properties in TLF (5 measurable parameters)
Time frame: 1. baseline (before hippotherapy starts): all groups 2. in 2 weeks (midway through the therapy): all groups 3. in 4 weeks (at the end of hippotherapy): all groups 4. one day after the completion of the 4-week hippotherapy: only experimental groups
1. oscillation frequency (F)-Hz 2. dynamic stiffness (S)-N/m 3. oscillation decrement (D)-arb 4. mechanical stress relaxation time (R)-ms (milliseconds) 5. creep (C)-arb
Functional tests (7 measurable parameters)
Time frame: 1. baseline (before hippotherapy starts): all groups 2. in 2 weeks (midway through the therapy): all groups 3. in 4 weeks (at the end of hippotherapy): all groups 4. one day after the completion of the 4-week hippotherapy: only experimental groups
1. 10-meter walk test (comfortable walking)-10 m/time spent in seconds 2. 10-meter walk test ( fast walking)-10 m/time spent in seconds 3. cadence (steps/minute) 4. a one-leg stance test with eyes open-seconds 5. a one-leg stance test with eyes closed-seconds 6. functional reach test forward-centimetres 7. functional reach test lateral-centimetres
1 secondary outcome
Quality of life of children and Quality of live of their parents/caregivers
Time frame: 1. baseline (before hippotherapy starts) 2. in 4 weeks (at the end of hippotherapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy (CP)
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
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.
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 1x/week and Hippotherapy 2x/week in people with Cerebral Palsy (CP) and Rehabilitation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 6 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: opening soon, as of the sponsor's last update on 21 Aug 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabina Devjak Novak, PhD (+38640294213, sabina.d.novak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viscoelastic properties in TLF (5 measurable parameters) (time frame: 1. baseline (before hippotherapy starts): all groups 2. in 2 weeks (midway through the therapy): all groups 3. in 4 weeks (at the end of hippotherapy): all groups 4. one day after the completion of the 4-week hippotherapy: only experimental groups). 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?
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 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.