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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04833868
Other study ID # BMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2020
Est. completion date March 7, 2021

Study information

Verified date April 2021
Source Batterjee Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date March 7, 2021
Est. primary completion date December 18, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hippotherapy and schroth exercise
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 exercise
pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise

Locations

Country Name City State
Saudi Arabia Battarjee Medical College Jeddah

Sponsors (2)

Lead Sponsor Collaborator
Batterjee Medical College Taif University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary FVC in liters change in FVC measured Using Spiromaster PC-10 Spirometer ten weeks
Primary FEV1 in liters change in FEV1 measured Using Spiromaster PC-10 Spirometer ten weeks
Primary MVV in liters/min change in MVV measured Using Spiromaster PC-10 Spirometer ten weeks
Primary FEV1/FVC in percentage change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer ten weeks
Primary aerobic capacity 6MWT ten weeks
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