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

Официальное название

The Effects of Hippotherapy on Viscoelastic Properties of Thoracolumbar Fascia and Quality of Life in Children With Spastic Cerebral Palsy and Their Parents/Caregivers

Обзор

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.

Вмешательства

• Другое Hippotherapy 1x/week
  This group will perform hippotherapy once per week for 12 weeks
• Другое Hippotherapy 2x/week
  This group will perform hippotherapy twice per week for 12 weeks

Первичные конечные точки

• Change in viscoelastic properties in TLF (5 measurable parameters) [Срок оценки: 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) [Срок оценки: 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]

Вторичные конечные точки (1)

• Quality of life of children and Quality of live of their parents/caregivers [Срок оценки: 1. baseline (before hippotherapy starts) 2. in 4 weeks (at the end of hippotherapy)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Словения · 1 центр

• Konjeniški zavod Epona — Novo Mesto

Идентификаторы

NCT: NCT07134582 · HYPPOTER25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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