Idiopathic ScoliosisNCT04885023
Efficacy Hippotherapy on Postural Asymmetries and Balance in Adolescents With Idiopathic Scoliosis
A study testing Hippotherapy in people with Idiopathic Scoliosis and Equine-assisted Therapy, run by Batterjee Medical College at 1 site in Saudi Arabia.
Trial summary
This study showed that the addition of hippotherapy to Schroth exercises is more effective in improving postural asymmetry and balance ability in adolescents with idiopathic scoliosis compared to Schroth exercises alone. Therefore, this combination should be considered during designing a rehabilitation program for AIS Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis, Equine-assisted Therapy
- What is being tested?
- Hippotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Feb 2020to 7 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hippotherapy on Postural Asymmetries and Balance in Adolescents With Idiopathic Scoliosis: a Randomized Controlled Study
This study showed that the addition of hippotherapy to Schroth exercises is more effective in improving postural asymmetry and balance ability in adolescents with idiopathic scoliosis compared to Schroth exercises alone. Therefore, this combination should be considered during designing a rehabilitation program for AIS
Read the 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.
- Conditions
- Idiopathic Scoliosis, Equine-assisted Therapy
- Being tested
- Hippotherapy
- Keywords
- Hipptherapy, Formateric, Balance, Schroth exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Also called Schroth exercises
The hippotherapy program for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Twenty six patients who received hippotherapy combined with Schroth exercises for ten weeks Receives: Other: Hippotherapy |
| Control group | Other | Twenty six patients who received only Schroth exercises for ten weeks Receives: Other: Hippotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliotic angle un degrees
Measured by formatric 4-D system
Measured: 10 weeks
Kyphotic angle in degrees
Measured by formatric 4-D system
Measured: 10 weeks
Pelvic obliquity in degrees
Measured by formatric 4-D system
Measured: 10 weeks
Pelvic torsion in degrees
Measured by formatric 4-D system
Measured: 10 weeks
Vertical spinal rotation in degrees
Measured by formatric 4-D system
Measured: 10 weeks
Secondary outcomes (3)
Overall balance index
Measured by Biodex Balance System
Measured: 10 weeks
Anteroposterior balance index
Measured by Biodex Balance System
Measured: 10 weeks
Mediolateral balance index
Measured by Biodex Balance System
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start20 Feb 2020
- Primary completion18 Dec 2020
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 52 patients (15 males and 37 females) participated in the current study, assigned to 2 groups, which were the group A who received hippotherapy combined with Schroth exercises and group B who received only Schroth exercises
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Taif University
- Responsible party
- Principal investigator, Osama Ragaa Abdelraouf Ibrahim, Batterjee Medical College
- Investigators
- Amr A AbdelAziem, Ph.D, Principal investigator, Tyiaf University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885023
- Sponsor's protocol ID
- Batterjee Medical College
- Other IDs
- (TURSP-2020/82)
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Will Be available only for third parties
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hippotherapy on Postural Asymmetries and Balance in Adolescents With Idiopathic Scoliosis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04885023
- Acronym / sponsor ID
- Batterjee Medical College
- Conditions
- Idiopathic Scoliosis, Equine-assisted Therapy
- Keywords
- Hipptherapy, Formateric, Balance, Schroth exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Collaborators
- Taif University
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study showed that the addition of hippotherapy to Schroth exercises is more effective in improving postural asymmetry and balance ability in adolescents with idiopathic scoliosis compared to Schroth exercises alone. Therefore, this combination should be considered during designing a rehabilitation program for AIS
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 52 patients (15 males and 37 females) participated in the current study, assigned to 2 groups, which were the group A who received hippotherapy combined with Schroth exercises and group B who received only Schroth exercises
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: HippotherapyTwenty six patients who received hippotherapy combined with Schroth exercises for ten weeks |
| Control group | Other | Other: HippotherapyTwenty six patients who received only Schroth exercises for ten weeks |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HippotherapyAlso: Schroth exercisesThe hippotherapy program for 10 weeks | Other | Control group, Study group |
Primary outcome
Scoliotic angle un degrees
Time frame: 10 weeks
Measured by formatric 4-D system
Kyphotic angle in degrees
Time frame: 10 weeks
Measured by formatric 4-D system
Pelvic obliquity in degrees
Time frame: 10 weeks
Measured by formatric 4-D system
Pelvic torsion in degrees
Time frame: 10 weeks
Measured by formatric 4-D system
Vertical spinal rotation in degrees
Time frame: 10 weeks
Measured by formatric 4-D system
3 secondary outcomes
Overall balance index
Time frame: 10 weeks
Anteroposterior balance index
Time frame: 10 weeks
Mediolateral balance index
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No. Data Will Be available only for third parties
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr A AbdelAziem, Ph.D principal investigator
Tyiaf University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy in people with Idiopathic Scoliosis and Equine-assisted Therapy, run by Batterjee Medical College at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliotic angle un degrees (time frame: 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.