Neuroproprioceptive Equine-Assisted Physiotherapy for Spinal Muscular Atrophy (NEUROEQUIP)

Charles University, Czech Republic

Status: Begins enrollment in 2 months

Conditions: Spinal Muscular Atrophy (SMA)

Treatments: Behavioral: Therapeutic grooming; Behavioral: Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"; Behavioral: Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition

Study type: Interventional

Funder types: Other

Identifiers

NCT07336602

SVV 260533/SVV/2024 (Other Grant/Funding Number)

GAUK 4424/2024 (Other Grant/Funding Number)

4424

Cooperatio Neurosciences (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Spinal Muscular Atrophy (SMA) is an autosomal recessive neuromuscular disorder caused by deletions or mutations of the SMN1 gene with retention of its paralog SMN2. Despite recent advances in disease-modifying treatments, SMA remains the leading genetic cause of infant mortality and continues to require multidisciplinary supportive care to achieve optimal outcomes. Physiotherapy is an integral part of this care, helping to maintain mobility, prevent contractures, and enhance quality of life.

Historically, physical activity was discouraged in SMA because of concerns that exercise might accelerate motor-neuron degeneration. Subsequent evidence has shown that inactivity contributes to weakness and fatigue, whereas appropriately dosed physical therapy improves postural control, endurance, and respiratory function. Modern rehabilitation therefore emphasizes functional mobility, balance training, and gait rehabilitation. Experimental studies have also demonstrated that specific exercise parameters can activate neuroprotective mechanisms independent of SMN protein expression, suggesting that motor-unit activation itself may support neuronal health.

Building on these findings, the present study introduces Equine-Assisted Physiotherapy Based on Neuro-proprioceptive "Facilitation and Inhibition" (NEUROEQUIP-SMA)-an innovative physiotherapeutic approach designed for children with SMA. This method combines the dynamic multisensory input of equine movement with the principles of neuroproprioceptive facilitation and inhibition, in which appropriate afferent stimuli modulate interneuronal excitability to optimize transmission within motor pathways. The technique aims to lower the excitability threshold of motor neurons so that impulses from the central nervous system can effectively induce muscular activation. Similar neurofacilitation strategies are routinely used in Czech neurorehabilitation for patients after stroke or with multiple sclerosis, but their potential in SMA has not yet been systematically studied.

The NEUROEQUIP-SMA method is compared with a standard physiotherapy program based on neuroproprioceptive facilitation and inhibition principles delivered in an outpatient setting. Both approaches target postural alignment, trunk stability, and functional motor control. The equine-assisted modality is expected to further enhance outcomes by promoting rhythmic pelvic activation, symmetric weight shifting, coordinated engagement of weakened muscle chains, and improved respiratory patterning through the horse's cyclic movement.

The study uses a randomized crossover design to evaluate short-term effects after an intensive six-day program. Primary outcomes include changes in motor function, postural control, and respiratory parameters, complemented by surface electromyography to monitor muscle fatigue. Secondary measures address quality of life, psychomotor development, and parent-reported well-being.

As an exploratory molecular component, peripheral blood will be analyzed for selected long non-coding RNAs (lncRNAs) such as SMN-AS1, MALAT1, PARTICLE, MEG3, NEAT1, H19, and GAS5. These transcripts are involved in motor-neuron development and chromatin regulation through PRC2-associated mechanisms. Their expression changes may serve as potential biomarkers reflecting neurophysiological effects of intensive physiotherapy in SMA.

The study was reviewed and approved by the Ethics Committee of the Third Faculty of Medicine, Charles University, Prague, Czech Republic. The intervention is short-lasting, low-risk, and non-pharmacological; therefore, a formal Data Monitoring Committee was not required. The findings are expected to contribute to evidence-based recommendations for physiotherapeutic management of SMA and to provide insight into the molecular correlates of motor-function improvement.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Written informed consent provided by a parent or legal guardian

Exclusion criteria

• Hip dislocation
• Known allergy to horses or the stable environment
• Severe fear of horses that would prevent participation in equine-assisted physiotherapy

Any other medical condition that, in the investigator's opinion, would interfere with safe participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Sequence A

Experimental group

Description:

Participants first receive NEUROEQUIP-SMA (Equine-Assisted Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition) for six consecutive days, followed by a washout period of 6 weeks to 3 months, and then Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition (SMA-SOC-N) for six consecutive days. Each phase includes standardized Therapeutic Grooming.

Treatment:

Behavioral: Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition

Behavioral: Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"

Behavioral: Therapeutic grooming

Sequence B

Experimental group

Description:

Participants first undergo six days of standard individual outpatient physiotherapy based on neuro-proprioceptive facilitation and inhibition (SMA-SOC-N), followed by a washout period of 6-12 weeks, and then six days of equine-assisted physiotherapy based on neuro-proprioceptive facilitation and inhibition (NEUROEQUIP-SMA). Each phase includes a standardized therapeutic grooming component.

Treatment:

Behavioral: Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition

Behavioral: Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"

Behavioral: Therapeutic grooming