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

NCT07134582 | Not Yet Recruiting

• 1 other identifier: HYPPOTER25
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Change in viscoelastic properties in TLF (5 measurable parameters)

  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

  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)

  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. 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

  1. baseline (before hippotherapy starts) 2. in 4 weeks (at the end of hippotherapy)

Study Arms (3)

Hippotherapy 1x/week

EXPERIMENTAL

Other: Hippotherapy 1x/week

Hippotherapy 2x/week

EXPERIMENTAL

Other: Hippotherapy 2x/week

Control

NO INTERVENTION

Interventions

Hippotherapy 1x/week OTHER

This group will perform hippotherapy once per week for 12 weeks

Hippotherapy 1x/week

Hippotherapy 2x/week OTHER

This group will perform hippotherapy twice per week for 12 weeks

Hippotherapy 2x/week

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Konjeniški zavod Epona

Novo Mesto, Dolenjska, 8000, Slovenia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sabina Devjak Novak, PhD

CONTACT

+38640294213; sabina.d.novak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)