Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis
Primary Purpose
Scoliosis Idiopathic
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
hippotherapy and schroth exercise
schroth exercise
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring Hippotherapy, Pulmonary Function, Idiopathic Scoliosis
Eligibility Criteria
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
Sites / Locations
- Battarjee Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hippotherapy combined with Schroth Exercise
Schroth Exercise
Arm Description
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
received Schroth's intervention for a 60-minute session, 3 times/ week for 10 weeks
Outcomes
Primary Outcome Measures
FVC in liters
change in FVC measured Using Spiromaster PC-10 Spirometer
FEV1 in liters
change in FEV1 measured Using Spiromaster PC-10 Spirometer
MVV in liters/min
change in MVV measured Using Spiromaster PC-10 Spirometer
FEV1/FVC in percentage
change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer
aerobic capacity
6MWT
Secondary Outcome Measures
Full Information
NCT ID
NCT04833868
First Posted
March 31, 2021
Last Updated
April 8, 2021
Sponsor
Batterjee Medical College
Collaborators
Taif University
1. Study Identification
Unique Protocol Identification Number
NCT04833868
Brief Title
Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis
Official Title
Efficacy of Hippotherapy Combined With Schroth Exercises on Pulmonary Function and Aerobic Capacity in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
March 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College
Collaborators
Taif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
Keywords
Hippotherapy, Pulmonary Function, Idiopathic Scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hippotherapy combined with Schroth Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Schroth Exercise
Arm Type
Active Comparator
Arm Description
received Schroth's intervention for a 60-minute session, 3 times/ week for 10 weeks
Intervention Type
Other
Intervention Name(s)
hippotherapy and schroth exercise
Intervention Description
pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise
Intervention Type
Other
Intervention Name(s)
schroth exercise
Intervention Description
pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise
Primary Outcome Measure Information:
Title
FVC in liters
Description
change in FVC measured Using Spiromaster PC-10 Spirometer
Time Frame
ten weeks
Title
FEV1 in liters
Description
change in FEV1 measured Using Spiromaster PC-10 Spirometer
Time Frame
ten weeks
Title
MVV in liters/min
Description
change in MVV measured Using Spiromaster PC-10 Spirometer
Time Frame
ten weeks
Title
FEV1/FVC in percentage
Description
change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer
Time Frame
ten weeks
Title
aerobic capacity
Description
6MWT
Time Frame
ten weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M. Abdel Ghafar, Ph.D
Organizational Affiliation
Batterjee Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Battarjee Medical College
City
Jeddah
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis
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