About this trial
This study investigates whether Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition" (NEUROEQUIP-SMA) can improve movement, posture, breathing, and quality of life in children with spinal muscular atrophy (SMA). This therapy uses the horse's rhythmic movement together with targeted sensory and manual stimulation to trigger natural motor reactions starting from the pelvis, lower the threshold for muscle activation, and support coordinated motor patterns. The study compares this method with standard individual physiotherapy based on the same neuro-proprioceptive facilitation and inhibition principles, but performed without the horse. Twenty children aged 2 to 9 years will receive both therapies in two separate 6-day blocks, in random order (crossover design). The researchers will assess muscle fatigue, coordination, breathing function, movement quality and quantity, quality of life, and changes in selected blood biomarkers. The results may help develop better rehabilitation strategies for children with SMA who are receiving modern pharmacological or gene therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 2 and 9 years
Clinical diagnosis of spinal muscular atrophy (SMA) type I, II, or III
Stable health condition for at least 6 months prior to enrollment
Ability to participate in the study procedures
Disqualifiers
Hip dislocation
Known allergy to horses or the stable environment
Severe fear of horses that would prevent participation in equine-assisted physiotherapy
Trial design
Crossover
Treatments tested in this trial
Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"
BehavioralEquine-assisted physiotherapy applying the principles of neuro-proprioceptive facilitation and inhibition. Conducted twice daily for 15 minutes over six consecutive days under the supervision of a certified physiotherapist and a trained horse leader. The intervention utilizes the horse's rhythmic, three-dimensional movement to generate dynamic proprioceptive, vestibular, and tactile stimuli that activate physiological postural reactions and coordinated muscle chains. The goal is to improve trunk stability, breathing control, movement symmetry, and functional motor coordination in children with spinal muscular atrophy. The therapy is delivered in a controlled equine environment, using manual facilitation and specific body positioning to modulate neuronal excitability and enhance neuromuscular function.
Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition
BehavioralStandardized outpatient physiotherapy program based on neuro-proprioceptive facilitation and inhibition, performed once daily for 30 minutes over six consecutive days. Delivered by an experienced physiotherapist in a clinical setting, the intervention includes active and assisted movement exercises, breathing techniques, stretching, postural correction, and positioning strategies to prevent contractures, maintain range of motion, and support trunk and respiratory control. The therapy applies targeted afferent stimuli to modulate motoneuron excitability and improve voluntary activation of motor units. The approach follows international standards of SMA rehabilitation, focusing on optimizing postural alignment, movement efficiency, and overall motor performance.
Therapeutic grooming
BehavioralStructured horse-care activity included in both treatment periods to control for psychosocial and environmental effects of horse interaction. Conducted once daily for approximately 20 minutes under therapist supervision, therapeutic grooming involves guided brushing, tactile contact, and communication with the horse in a safe and supportive setting. The activity promotes sensory integration, body awareness, and emotional regulation, while preparing the child for subsequent equine-assisted sessions. Although not a primary therapeutic modality, it standardizes the environmental exposure across study arms and supports comfort, motivation, and engagement in children participating in physiotherapeutic interventions.
Treatment groups
Trial outcomes
Primary outcomes
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders
A clinical assessment tool used to evaluate motor function in infants with neuromuscular disorders measures their ability to perform specific movements and assesses the severity of motor impairments. Measurements are recorded during the test and are later evaluated by two independent physiotherapists. Scores range from 0 to 64, with higher scores indicating better motor function.
Secondary outcomes
Change in Relative Expression of Selected lncRNAs
Relative expression of a predefined panel of long non-coding RNAs (lncRNAs) in peripheral blood, measured by quantitative PCR and normalized to reference genes. For reporting purposes, the mean fold change across the predefined lncRNA panel will be calculated and reported as a single outcome value.
Change in Median Frequency of Surface EMG Signal
Median frequency of the surface electromyography (sEMG) signal recorded from the external oblique abdominal muscle during a standardized repetitive movement task. Lower median frequency values over repeated contractions indicate improved muscle efficiency and reduced fatigue.
The Trunk Control Measurement Scale (TCMS)
The Trunk Control Measurement Scale (TCMS) is a clinical assessment tool that evaluates trunk control during static and dynamic sitting balance tasks. It measures selective movement control in the trunk and coordination between upper and lower body segments. Although validated primarily in children with cerebral palsy, it is also used to assess postural control in children with other neuromotor disorders such as SMA. The total score ranges from 0 to 58, with higher scores indicating better trunk control.
The Segmental Assessment of Trunk Control (SATCo)
The Segmental Assessment of Trunk Control (SATCo) is a standardized test designed to identify the highest level of segmental trunk control in sitting. It assesses static, active, and reactive control at seven levels of trunk support. Although originally developed for children with cerebral palsy, it has been used in other pediatric neuromotor populations to evaluate trunk stability and postural development. Scores range from 0 to 20, with higher scores indicating better trunk control.
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