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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05505695
Other study ID # Schroth Exercises
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2, 2019
Est. completion date September 11, 2020

Study information

Verified date July 2022
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: In the present study, we aimed to evaluate the effect of regular Schroth exercises on pulmonary functions in adolescent idiopathic scoliosis (AIS) patients who use rigid braces and perform Schroth exercises regularly. Objective: The main purpose of this study, is to investigate the effects of Schroth exercises on pulmonary functions in adolescents who use rigid braces and perform Schroth exercises regularly. Methods: Twenty-four patients with AIS were included in the study. The patients who wore rigid braces and performed the SSE therapy constituted the "Brace&Exercise" (N=12), and the patients who wore full-time rigid braces but did not perform exercise constituted the "Brace Group" (N=12) of the study. The effects of Schroth exercises on pulmonary functions were measured at the beginning of treatment and the 8th week of the treatment. Keywords: Adolescent, idiopathic scoliosis, conservative treatment, brace, respiratory function, Schroth exercises.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 11, 2020
Est. primary completion date September 11, 2020
Accepts healthy volunteers No
Gender All
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria: - 10-16 years, - 25-45 Cobb degree, - Brace and exercise treatment prescribed by the physician - Participation in the study was approved by the family/caregiver Exclusion Criteria: - Chronic respiratory diseases, - Professional athletes, - Did not perform the exercises regularly - Did not compliance the brace

Study Design


Intervention

Other:
Brace and Exercise Treatment
Schroth exercises, which are a specific exercise method for scoliosis, were given to the experimental group for 8 weeks, different from the control group.
Brace Treatment
Among the patients included in the study, those who wore braces but did not agree to exercise constituted the ''Brace Group'' of the study.

Locations

Country Name City State
Turkey Halic University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary FVC - Respiratory Functions Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible. The pulmonary function test was evaluated with two different measurements, both at the beginning of the treatment (T0) and at the 8th week of the treatment (T1). The data obtained was determined as the primary outcome of the study, and the patients in both groups were administered by the research physiotherapist. For respiratory function tests were used a handheld type spirometer (SP10W, Contec). For the spirometric measurement, the patient was seated on the chair and a clip was placed on the patient nose to keep the nostril closed. Afterward, the device was placed in the patient's mouth, they were asked to take a deep breath and exhale into the device with maximum force. This process was repeated three times and the highest value among the measurements was recorded as respiratory function data. 8 Weeks
Primary FEV1 - Respiratory Functions Forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximum inspiration. The pulmonary function test was evaluated with two different measurements, both at the beginning of the treatment (T0) and at the 8th (T1) week of the treatment. The obtained data were determined as the primary outcome of the study and the patients in both groups were administered the same procedure by the researcher physiotherapist. 8 Weeks
Primary PEF - Respiratory Functions Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate. The pulmonary function test was evaluated with two different measurements, both at the beginning of the treatment (T0) and at the 8th (T1) week of the treatment. The obtained data were determined as the primary outcome of the study and the patients in both groups were administered the same procedure by the researcher physiotherapist. 8 Weeks
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