- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885023
Efficacy Hippotherapy on Postural Asymmetries and Balance in Adolescents With Idiopathic Scoliosis
Effects of Hippotherapy on Postural Asymmetries and Balance in Adolescents With Idiopathic Scoliosis: a Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The hippotherapy program started with a physical therapy assessment to develop specific corrective movements to be practiced while riding the horse based on the direction of the spinal curvature. Interventions were performed by a licensed physical therapist experienced with hippotherapy at two local therapeutic riding centers. The participants received 15 sessions split into two phases over 10 weeks. In the first phase, during the first 5 weeks, they performed 30 minutes of walking and sitting trot training without a stirrup iron once a week. The frequency was then raised to twice a week for the rest of the treatment program. Before the start of the intervention, two familiarization sessions were given to clarify safety guidelines, riding mistakes, and create a riding rapport with the horse. The individuals wore protective helmets during each hippotherapy session and mounted on a moving horse on walk and/or trot performing different positions, namely forward astride, side sitting, backward astride, sometimes with transitions between positions and often while the horse was moving. To restore normal alignment of the spine, participants were also asked to ride without holding on with their hands to perform self-correction movements. Examples of these movements include raising both arms high to decrease the degree of thoracic kyphosis, bending the upper trunk towards the convex side of the curve, raising the arm on the concave side with scapular adduction to level both shoulders. To correct pelvic obliquity, a small pad was put under the hip on the side of the lumbar convexity. Under the instructions of the physical therapist, a leader pulled the horse reins in front to control the horse gait, gait velocity, and orient the horse in different directions . All these movements activate the patient's neuromuscular and sensory reactions.
Both groups performed Schroth exercises that are patient-specific asymmetric exercises with rotational breathing methods used for three-dimensional correction. For the first 2 weeks, there were five 1-h long individual sessions during which the participants were trained in their home exercise program. This was followed by 1-h weekly visits and paired with their daily home exercises. These exercises aimed to provide and promote enhanced postural control by using asymmetrical standing postural exercises specifically designed to restore body balance and mobility. During ground exercises, aid pads were used to build pressure for costal protrusions and/or trunk asymmetry correction. Postural correction was facilitated by rotational breathing exercises focusing on the concave side of the thorax. During the therapy sessions, postural correction principles of the Schroth process, axial elongation, deflection, de-rotation, facilitation, stabilization, were used.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Makkah
-
Jeddah, Makkah, Saudi Arabia, 21442
- Batterjee Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- AIS,
- all curve types,
- curves with Cobb angle ranged between 10 and 25 degrees,
- a Risser grade 0 to 5, and
- the ability to attend weekly visits.
Exclusion Criteria:
- Children with any significant history of riding horses,
- with diagnosis other than AIS,
- having other treatment which might affect scoliosis,
- having chronic diseases requiring any drug usage,
- presence of other neurologic, muscular or rheumatic diseases, and
- having non-idiopathic scoliosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Study group
Twenty six patients who received hippotherapy combined with Schroth exercises for ten weeks
|
The hippotherapy program for 10 weeks
Other Names:
|
|
OTHER: Control group
Twenty six patients who received only Schroth exercises for ten weeks
|
The hippotherapy program for 10 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scoliotic angle un degrees
Time Frame: 10 weeks
|
Measured by formatric 4-D system
|
10 weeks
|
|
Kyphotic angle in degrees
Time Frame: 10 weeks
|
Measured by formatric 4-D system
|
10 weeks
|
|
Pelvic obliquity in degrees
Time Frame: 10 weeks
|
Measured by formatric 4-D system
|
10 weeks
|
|
Pelvic torsion in degrees
Time Frame: 10 weeks
|
Measured by formatric 4-D system
|
10 weeks
|
|
Vertical spinal rotation in degrees
Time Frame: 10 weeks
|
Measured by formatric 4-D system
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall balance index
Time Frame: 10 weeks
|
Measured by Biodex Balance System
|
10 weeks
|
|
Anteroposterior balance index
Time Frame: 10 weeks
|
Measured by Biodex Balance System
|
10 weeks
|
|
Mediolateral balance index
Time Frame: 10 weeks
|
Measured by Biodex Balance System
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amr A AbdelAziem, Ph.D, Tyiaf University, Saudi Arabia
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Batterjee Medical College
- (TURSP-2020/82) (OTHER_GRANT: Taif University, Saudi Arabia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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