Equine-Assisted Physiotherapy for Spinal Muscular Atrophy

NCT05341453 | Completed

• 1 other identifier: 18032022
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study evaluates the immediate and sustained effects of intensive equine-assisted physiotherapy in children with spinal muscular atrophy (SMA). The study compares an intensive equine-assisted physiotherapy program (NEUROEQUIP-SMA) with an individualized physiotherapy program based on SMA standard of care and neuroproprioceptive facilitation and inhibition principles (SMA-SOC-N). Both interventions are delivered as intensive 6-day rehabilitation programs. Outcomes include motor function, postural control, respiratory function, movement quality assessed by three-dimensional motion analysis, neuromuscular activity, quality of life, and selected molecular biomarkers. The study also evaluates the safety and tolerability of intensive rehabilitation in children with SMA.

Conditions

Spinal Muscular Atrophy

Keywords

hippotherapy; children; psychomotor development; physiotherapy; quality of life; posture; motor skills; therapeutic riding; muscle fatigue

Outcome Measures

Primary Outcomes (9)

• Abdominal Breathing Ability Test

  The child performs deep breathing while sitting astride a therapy cylinder. Reflective markers attached to predefined anatomical landmarks are recorded using the Qualisys Motion Capture System during a 30-second measurement. The test evaluates thoracic and abdominal movement during breathing. Improved function is reflected by greater abdominal contribution to the breathing pattern.

  Baseline and end Day 7

• Test of Trunk and Cervical Spine Coordination Ability

  The child performs repeated back-and-forth upper limb movements while sitting on a therapy cylinder (typically 3-6 repetitions). The test evaluates trunk and cervical spine coordination by analyzing the synchronization of markers placed on the dorsum of the hand, C7 vertebra, and temporomandibular joint. Improved function is reflected by better coordination of trunk, upper limb, and cervical spine movements with reduced compensatory cervical spine extension.

  Baseline and Day 7

• Ability to Work With the Center of Gravity

  While sitting on a therapy cylinder, the child performs repeated reaching movements with one upper limb (3-6 repetitions during a 30-second recording). The test evaluates postural stability and control of the center of gravity by analyzing displacement of body markers during the task. Improved function is reflected by greater controlled displacement of the center of gravity while maintaining postural stability.

  Baseline and day 7

• Muscle fatigue

  Investigators will measure muscle fatigue after physical activity using surface EMG. The child will lie on his back, therapist will provide a toy in the area of his opposite knee. The child will reach for a toy. This act will be 30 s. Investigators will evaluate activity m.obliquus externus abdominis at the beginning and end of this specific activity. Goal is to evaluate muscle fatigue. Investigators assume, that after intensive therapeutic program will be muscle fatigue lower.

  Baseline and Day 7

• Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND)

  The CHOP INTEND is a validated clinical scale designed to assess motor function in infants and young children with spinal muscular atrophy. It consists of 16 items. Total scores range from 0 to 64, with higher scores indicating better motor function.

  Baseline and Day 7

• Hammersmith function scale for children with spinal muscular atrophy

  The examination will follow a standardized procedure. The maximum score of the standardized test is 64 points on each side, the minimum is 0 points. A higher score means an improvement in the child's movement possibilities.

  Baseline and Day 7

• Deep neck flexor endurance test

  The examination will follow a standardized procedure. Longer holding in the position means a better result, the exact holding time is not standardized for this test.

  Baseline and Day 7

• Neck extensor endurance test

  The examination will follow a standardized procedure. Longer holding in the position means a better result, the exact holding time is not standardized for this test.

  Baseline and Day 7

• Spirometric measure

  The spirometer will be used to determine the forced expiratory volume in one second (FEV1) value, i.e. the volume of air exhaled after maximal inspiration with the greatest effort within the first second and peak expiratory flow (PEF). The change in both parameters at the beginning and end of the rehabilitation stay will be evaluated.

  Baseline and Day 7

Secondary Outcomes (3)

• ICF-based assessment

  Baseline; 28 days after completion of rehabilitation

• Monitoring of molecular biological indicators of rehabilitation

  Baseline and Day 7

• Home video recording

  Baseline; 28 days after completion of rehabilitation

Study Arms (3)

Individual physiotherapy (SMA-SOC-N)

ACTIVE COMPARATOR

Individual physiotherapy will be performed according to the SMA-SOC-N protocol, based on the principles of the international Standard of Care (SMA-SOC) recommendations and adapted to the individual needs of children with spinal muscular atrophy.

Procedure: Individual physiotherapy (SMA-SOC-N)

Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition

EXPERIMENTAL

Equine-assisted physiotherapy based on neuroproprioceptive facilitation and inhibition is an accredited form of hippotherapy. Its methodology was originally developed based on the clinical presentation of children with cerebral palsy; however, its therapeutic principles are applicable to a broader group of children with neurological disabilities, including children with spinal muscular atrophy.

Procedure: Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition

Therapeutic grooming

OTHER

In order to influence the psychomotor development in a comprehensive way, the psychosocial activity of therapeutic grooming will also be included in the study. Its goal is to support children's communication, their interaction with the environment, the ability to establish contact with the horse and the overall emotional support of children with SMA.

Procedure: Therapeutic grooming

Interventions

Individual physiotherapy (SMA-SOC-N) PROCEDURE

Therapeutic procedures according to the international Standard of Care (SMA-SOC) recommendations, complemented by the principles of neuroproprioceptive facilitation and inhibition, will be used during therapy. Elements of breathing gymnastics, vibration techniques, stretching, eccentric and concentric exercise procedures will be combined. Individual physiotherapy will be conducted on the basis of set goals from the kinesiological examination, it will be adapted to the individuality of the child - his cooperation, fatigue and sleep time.

Individual physiotherapy (SMA-SOC-N)

Therapeutic grooming PROCEDURE

In order to influence the psychomotor development in a comprehensive way, the psychosocial activity of therapeutic grooming will also be included in the study. Its goal is to support children's communication, their interaction with the environment, the ability to establish contact with the horse and the overall emotional support of children with SMA. The purpose of this activity is to clean the horse, its possible guide, stroking and contact with the horse, work from the ground.

Therapeutic grooming

Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition PROCEDURE

HT by CP is an accredited form of hippotherapy, whose methodology is based on the clinical picture of cerebral palsy. In this study, the accredited HT by CP methodology was applied to children with spinal muscular atrophy and complemented by principles of neuroproprioceptive facilitation and inhibition. Based on a special type of examination, this method precisely determines the "type / breed" of the horse according to the biomechanics of the movement of its back in the step, the position of the child and the neurophysiological function of the back - differentiation or sensorimotor skills. Furthermore, according to the course of therapy, the physiotherapist determines the pace of the horse's step, its length, selects special manual contacts according to the current situation and adjusts the duration of therapy to the client's fatigue. Therapy will be performed by therapists with professional competence to perform hippotherapy by children with CP.

Also known as: Hippotherapy by the children with cerebral palsy (HT by CP)

Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinic diagnosis SMA (I, II, and III types)
• no changing medicine 6 months at least
• without another grave diseases

You may not qualify if:

• hip luxation
• allergies to horses and the environment of horse stables
• insurmountable fear of the horse

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Kamila Řasová

Prague, 128 00, Czechia

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Kamila Rasova, as.prof.Dr.

  Clinic of rheumatology and rehabilitation, Third medical faculty CU and Faculty Thomayer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants of the study will undergo a clinical examination including a questionnaire survey, led by a blinded independent examiner, who will not have access to intervention documentation. The examiner will see each patient twice, before the first intervention and 6 days later in the end last therapy. The examiner will be prohibited to talk about the therapy attended. The parents of patients will be informed about the character of the examination ant the importance of the most objectivity possible. All therapists can apply both interventions, therefore masking is more efficient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. PhDr. Kamila Řasová, Ph.D.

Model Details: A prospective non-randomized interventional study. Participants will undergo intensive rehabilitation consisting of either individualized physiotherapy according to the SMA-SOC-N protocol or intensive equine-assisted physiotherapy, based on parental preference, the child's ability to tolerate the intervention, and program availability. Participants both groups will undergo 12 therapies, twice a day, 15 minutes long. Before the intervention and on Day 7, all participants will be examined by a blinded independent clinician.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: April 22, 2022
• Primary Completion: September 25, 2024
• Study Completion: October 20, 2024
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Done now: Study protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) 22.4. - 29.4.2022, 24.9. - 30.9.2022: Clinical Study Report (CSR) 2023 - 2024: Analytic Code
• Access Criteria: Researcher can write us for access to data code.

Locations

CZ (1)