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NCT Number: NCT07134582

Trial Examines Short-term Effects of Hippotherapy on Fascia Properties and Quality of Life in Children With CP.

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Fascia Hippotherapy Motor Coordination or Function Nervous System Diseases Quality of Life Rehabilitation

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hippotherapy 1x/week

Other

This group will perform hippotherapy once per week for 12 weeks

Hippotherapy 2x/week

Other

This group will perform hippotherapy twice per week for 12 weeks

Primary outcomes

  1. 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

    • oscillation frequency (F)-Hz
    • dynamic stiffness (S)-N/m
    • oscillation decrement (D)-arb
    • mechanical stress relaxation time (R)-ms (milliseconds)
    • creep (C)-arb

  2. 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

    • 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

Secondary outcomes

  1. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabina Devjak Novak, PhD

CONTACT

[email protected]

+38640294213

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study 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

Acronym: HYPPOTER25

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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