Scoliosis IdiopathicNCT04833868
Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis
A study testing hippotherapy and schroth exercise and schroth exercise in people with Scoliosis Idiopathic, run by Batterjee Medical College at 1 site in Saudi Arabia.
Trial summary
BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that negatively impacts the respiratory system and physical conditioning in adolescents. Hippotherapy is an equestrian intervention that optimizes physical performance and mobility in a bunch of contexts; however, its influence on… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- hippotherapy and schroth exercise and schroth exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all types of curves,
- curves between 10 and 20 degrees (29),
- Risser grade 0 to 5
- the availability to be engaged in once a week visit
Who cannot join
- Adolescents with:
- obstructive pulmonary diseases
- associated neuromuscular diseases
- recent infectious episodes in the previous two months
- history of cardiovascular or psychological disorders
- any significant history of riding horses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hippotherapy Combined With Schroth Exercises on Pulmonary Function and Aerobic Capacity in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that negatively impacts the respiratory system and physical conditioning in adolescents. Hippotherapy is an equestrian intervention that optimizes physical performance and mobility in a bunch of contexts; however, its influence on pulmonary function remains unclear.
AIM: This research aimed to analyze the impact of ten weeks of hippotherapy combined with Schroth exercises on ventilatory function and aerobic capacity in AIS.
Read more
DESIGN: Randomized Controlled Trial SETTING: Outpatients attend a single center that includes a rehabilitation room and recreational riding center.
POPULATION: Forty-five patients were arbitrarily recruited to the experimental (N= 22) and control group (N=23).
METHODS: Patients in the experimental group received 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks. The two groups attended a 60-minute session of Schroth's intervention, 3 times/ week for 10 weeks. Two-way ANOVA for between-group comparisons and independent t-test for within-group comparisons were used in the statistical analysis.
Read the detailed description
A total of 45 patients (13 males and 32 females) participated in the current study. The participants were assigned to one of two groups in a random manner: an experimental group who received hippotherapy combined with Schroth Exercise and the control group who received only schorth exercise. (FVC, FEV1, FEV1/FVC, MVV, and 6MWT) were measured before and after 10 weeks intervention
- Conditions
- Scoliosis Idiopathic
- Being tested
- hippotherapy and schroth exercise, schroth exercise
- Keywords
- Hippotherapy, Pulmonary Function, Idiopathic Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hippotherapy and schroth exerciseOther
pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise
schroth exerciseOther
pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise
| Study group | Role | What they receive |
|---|---|---|
| hippotherapy combined with Schroth Exercise | Experimental | received hippotherapy combined with Schroth Exercise hippotherapy session for 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks in addition to 60-minute session Schroth's intervention, 3 times/ week for 10 weeks Receives: Other: hippotherapy and schroth exercise |
| Schroth Exercise | Active comparator | received Schroth's intervention for a 60-minute session, 3 times/ week for 10 weeks Receives: Other: schroth exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC in liters
change in FVC measured Using Spiromaster PC-10 Spirometer
Measured: ten weeks
FEV1 in liters
change in FEV1 measured Using Spiromaster PC-10 Spirometer
Measured: ten weeks
MVV in liters/min
change in MVV measured Using Spiromaster PC-10 Spirometer
Measured: ten weeks
FEV1/FVC in percentage
change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer
Measured: ten weeks
aerobic capacity
6MWT
Measured: ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 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 Scoliosis IdiopathicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Taif University
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Mohamed M. Abdel Ghafar, Ph.D, Principal investigator, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833868
- Sponsor's protocol ID
- BMC
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hippotherapy Combined With Schroth Exercises on Pulmonary Function and Aerobic Capacity in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04833868
- Acronym / sponsor ID
- BMC
- Conditions
- Scoliosis Idiopathic
- Keywords
- Hippotherapy, Pulmonary Function, Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 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
- 6 Apr 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.
BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that negatively impacts the respiratory system and physical conditioning in adolescents. Hippotherapy is an equestrian intervention that optimizes physical performance and mobility in a bunch of contexts; however, its influence on pulmonary function remains unclear.
AIM: This research aimed to analyze the impact of ten weeks of hippotherapy combined with Schroth exercises on ventilatory function and aerobic capacity in AIS.
DESIGN: Randomized Controlled Trial SETTING: Outpatients attend a single center that includes a rehabilitation room and recreational riding center.
POPULATION: Forty-five patients were arbitrarily recruited to the experimental (N= 22) and control group (N=23).
METHODS: Patients in the experimental group received 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks. The two groups attended a 60-minute session of Schroth's intervention, 3 times/ week for 10 weeks. Two-way ANOVA for between-group comparisons and independent t-test for within-group comparisons were used in the statistical analysis.
Detailed description
A total of 45 patients (13 males and 32 females) participated in the current study. The participants were assigned to one of two groups in a random manner: an experimental group who received hippotherapy combined with Schroth Exercise and the control group who received only schorth exercise. (FVC, FEV1, FEV1/FVC, MVV, and 6MWT) were measured before and after 10 weeks intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| hippotherapy combined with Schroth Exercise | Experimental | Other: hippotherapy and schroth exercisereceived hippotherapy combined with Schroth Exercise hippotherapy session for 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks in addition to 60-minute session Schroth's intervention, 3 times/ week for 10 weeks |
| Schroth Exercise | Active comparator | Other: schroth exercisereceived Schroth's intervention for a 60-minute session, 3 times/ week for 10 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- all types of curves,
- curves between 10 and 20 degrees (29),
- Risser grade 0 to 5
- the availability to be engaged in once a week visit
Key exclusion criteria (6 listed)
- obstructive pulmonary diseases
- associated neuromuscular diseases
- recent infectious episodes in the previous two months
- history of cardiovascular or psychological disorders
- any significant history of riding horses
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 |
|---|---|---|
| hippotherapy and schroth exercisepulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise | Other | hippotherapy combined with Schroth Exercise |
| schroth exercisepulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise | Other | Schroth Exercise |
Primary outcome
FVC in liters
Time frame: ten weeks
change in FVC measured Using Spiromaster PC-10 Spirometer
FEV1 in liters
Time frame: ten weeks
change in FEV1 measured Using Spiromaster PC-10 Spirometer
MVV in liters/min
Time frame: ten weeks
change in MVV measured Using Spiromaster PC-10 Spirometer
FEV1/FVC in percentage
Time frame: ten weeks
change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer
aerobic capacity
Time frame: ten weeks
6MWT
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 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Mohamed M. Abdel Ghafar, Ph.D principal investigator
Batterjee Medical College
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 and schroth exercise and schroth exercise in people with Scoliosis Idiopathic, 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 4 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 Apr 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?
FVC in liters (time frame: ten 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 Apr 2021.