NCT05505695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 22, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 30, 2022

Last Update Submit

August 19, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

"Brace&Exercise Group"

EXPERIMENTAL

The patients who were the rigid brace and performed the SSE therapy in the specified constituted the Brace \& Exercise. Experimental group patients wore full-time rigid brace and Schroth exercises for 60 minutes 5 days a week by the physician.

Other: Brace and Exercise Treatment

"Brace Group"

ACTIVE COMPARATOR

The patients who wore full-time rigid braces but did not perform exercise constituted the Brace group. Comparator group patients wore full-time brace only, did not perform Schroth exercises.

Other: Brace Treatment

Interventions

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&Exercise Group"

Among the patients included in the study, those who wore braces but did not agree to exercise constituted the ''Brace Group'' of the study.

"Brace Group"

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years,
  • Cobb degree,
  • Brace and exercise treatment prescribed by the physician
  • Participation in the study was approved by the family/caregiver

You may not qualify if:

  • Chronic respiratory diseases,
  • Professional athletes,
  • Did not perform the exercises regularly
  • Did not compliance the brace

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 18, 2022

Study Start

December 2, 2019

Primary Completion

September 11, 2020

Study Completion

September 11, 2020

Last Updated

August 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations