Hippotherapy in Children With Spinal Muscular Atrophy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-10
SponsorCharles University, Czech Republic

About this trial

The randomized controlled trial is aimed to discover the physiotherapy and hippotherapy effect and efficacy on children with SMA. The concept is to utilized two types of physiotherapy - the first concept is classic physiotherapy and the second one is hippotherapy. The hippotherapy concept will be in intervals of 15 minutes twice a day, the physiotherapy will be in intervals of 30 minutes once a day. In-patient therapy will be for 6 days. The efficacy will be assessed by biomedical measures - Qualisys Motion Capture Systems 2020.3., by molecular biological markers (lncRNA) in blood and by surface electromyography (EMG). The primary goal of this study is to compare two physiotherapeutic approaches - the recommended form of classical physiotherapy and the method on a neurophysiological basis - hippotherapy. The secondary intention of the research will be the appropriate intensity of therapy so that unwanted muscle fatigue does not occur.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

clinic diagnosis SMA (I, II, and III types)

no changing medicine 6 months at least

without another grave diseases

Disqualifiers

hip subluxation

allergies to horses and the environment of horse stables

insurmountable fear of the horse

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individual physiotherapy (SMA-SOC)

    Procedure/Surgery

    Therapeutic procedures according to the recommended standard (SMA-SOC) will be used in the 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.

  • Hippotherapy

    Procedure/Surgery

    HT by CP is an accredited form of hippotherapy, whose methodology is based on the clinical picture of cerebral palsy, but its procedures are applicable to a wider group of children with disabilities. Therefore, investigators anticipate it´s effect for children with SMA. 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.

  • Therapeutic grooming

    Procedure/Surgery

    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.

Treatment groups

16 Participants
are divided into 3 treatment groups
Group A: Individual physiotherapy (SMA-SOC)Active comparator 1 intervention
Group B: Hippotherapy by the children with cerebral palsyExperimental treatment 1 intervention
Group C: Therapeutic groomingOther 1 intervention

Trial outcomes

Primary outcomes

1

The ability of the thorax to change shape

The examination will take place lying on your back. 3 position markers will be placed on each side of the thorax, in the area of the distal end of the sternum axes, at the level of the 3rd rib and at the lowest arch of the 10th rib. Their position during exhalation and inspiration will be measured, and the change in thorax circumference will be evaluated. The aim of this test is to objectify the change in respiratory stereotype. After therapy, investigators expect a greater ability of the thorax to change direction.

Time frame
15 minutes
2

Sitting symmetry

Observations will be made by sitting on a therapy cylinder. There will be special markers on the body (on clothes) of children: lower angles of the scapulae axes, ridge of the iliac axes, sacroiliac joint (SI) on both sides and in the area of the L4 vertebra and navel. Investigators will measure the symmetry of these marks in each other's position and the movement in which the child will walk back and forth with his hands. Markers will be analyzed using Qualisys Motion Capture Systems 2020.3. Acceleration and change of position will be evaluated in the second time.

Time frame
5 minutes
3

Work with the center of gravity

Observation will be performed by sitting on therapeutic cylinder. 3 position markers will be used on each side of the body, at the root of the palm, in the area of the SI joint and at the level of the temporomandibular joint. The change of markers will be measured from the starting position until the child is stretched to the side (torso tilt with lug) and forward (torso flexion with forearm). The monitoring child will be motivated to reach for the toy. The goal is to evaluate the stability of children. Investigators assume, that after therapy investigators can see better work with the center of gravity.

Time frame
10 minutes
4

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 stretch 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.

Time frame
10 minutes

Secondary outcomes

1

Quality of life assessment

Parents of child with SMA will fill special questionnaire at the beginning and 4-5 weeks after end of the rehabilitation. The ICF score set, more precisely the ICF-based Documentation Form, the category Children with cerebral palsy Brief (below 6 years old),supplemented by some items from the basic rehabilitation set, will be used to evaluate the quality of life.

Time frame
120 minutes
2

Monitoring of molecular biological indicators of rehabilitation

Samples treated in this way can be safely stored at room temperature for longer periods of time (up to three days or more). Blood samples stored in Ribonucleic acid (RNAlater)® Solution achieve RNA quality comparable to the quality of samples processed immediately according to commercial websites. The expected average total RNA yields will be about 2-4 /g / 0.5 ml all blood. Total RNA will be transcribed into complementary deoxyribonucleic acid complementary (cDNA) by reverse transcriptase. To avoid error, the expression of human lncRNA and internal endogenous gene (e.g., GAPDH) will be quantified using RNA obtained from blinded samples (i.e., concealment of sample origin allocation).

Time frame
10 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.