Hippotherapy in Children With Spinal Muscular Atrophy
HIPOSMA
The Effect of Intensive Hippotherapy on the Psychomotoric Development of Children With Spinal Muscular Atrophy
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2025
CompletedAugust 20, 2024
August 1, 2024
2.5 years
April 18, 2022
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
15 minutes
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.
5 minutes
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.
10 minutes
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.
10 minutes
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.
40 minutes
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.
5 minutes
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.
5 minutes
Spirometric measure
The spirometer will be used to determine the forced expiratory volume in 1 second forced expiratory volume at one second (FEV1) value, i.e the volume of air exhaled after the maximum inspiration with the greatest effort within 1 second. The change in value at the beginning and end of the rehabilitation stay will be evaluated.
2 minutes
Secondary Outcomes (2)
Quality of life assessment
120 minutes
Monitoring of molecular biological indicators of rehabilitation
10 minutes
Study Arms (3)
Individual physiotherapy (SMA-SOC)
ACTIVE COMPARATORIndividual physiotherapy will be performed according to the recommended SMA-SOC guidelines.
Hippotherapy by the children with cerebral palsy
EXPERIMENTALHippotherapy by the children with cerebral palsy 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 assume its effect for children with SMA.
Therapeutic grooming
OTHERIn 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.
Interventions
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.
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.
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.
Eligibility Criteria
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 subluxation
- allergies to horses and the environment of horse stables
- insurmountable fear of the horse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kamila Řasová
Prague, 128 00, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kamila Rasova, as.prof.Dr.
Clinic of rheumatology and rehabilitation, Third medical faculty CU and Faculty Thomayer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- 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.
Study Record Dates
First Submitted
April 18, 2022
First Posted
April 22, 2022
Study Start
April 22, 2022
Primary Completion
October 22, 2024
Study Completion
October 22, 2025
Last Updated
August 20, 2024
Record last verified: 2024-08
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.
Clinical Study Report (CSR) and Analytic Code will be shared when data is collected. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) are shared as attachment of this registration.