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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hippotherapy 1x/week

    Other intervention

    This group will perform hippotherapy once per week for 12 weeks

  • Hippotherapy 2x/week

    Other intervention

    This group will perform hippotherapy twice per week for 12 weeks

Treatment groups

27 Participants
are divided into 3 treatment groups
Group A: Hippotherapy 1x/weekExperimental treatment 1 intervention
Group B: Hippotherapy 2x/weekExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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
2

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

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

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.

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

Other outcomes

Sponsors and contacts

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