Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis

Sponsor
Scoliosis SOS Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05764499
Collaborator
(none)
53
1
33
1.6

Study Details

Study Description

Brief Summary

Introduction: Truncal shift caused by scoliosis can be measured with a Formetric Scanner using the Maximal Thoracic Apical Deviation (MTAD) measurement. It is a well-documented complaint with regards to body-image in patients with idiopathic scoliosis (IS). Furthermore, thoracic apical deviation is an important measure in pre-operative assessment and post-operative outcomes.

Objective: The aim of this retrospective cohort study was to determine the long-term effects of an intensive course of Physiotherapy Scoliosis Specific Exercise (PSSE) on MTAD in patients with IS.

Methods: Consecutive IS patients with a single right-sided thoracic curvature who completed an intensive 4-week course of PSSE were recruited. Data was collected between April 2019 and December 2021. All patients were routinely scanned using a Formetric Scanner pre-, immediately post-, 12- and 24-months post-treatment. MTAD, measured in millimetres, was documented. Adults (>17 years old) (group 1) and children (group 2) were analysed separately.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiotherapy Scoliosis Specific Exercise (PSSE)

Study Design

Study Type:
Observational
Actual Enrollment :
53 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis: a 24 Month Follow up
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Children

Patients under the age of 18

Other: Physiotherapy Scoliosis Specific Exercise (PSSE)
Patients completed 120 hours of group based PSSE over a four week time frame. Monday - Friday, 10.00-17.00.

Adults

Patients 18 years old and above

Other: Physiotherapy Scoliosis Specific Exercise (PSSE)
Patients completed 120 hours of group based PSSE over a four week time frame. Monday - Friday, 10.00-17.00.

Outcome Measures

Primary Outcome Measures

  1. Maximal Thoracic Apical Deviation [Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment]

    Maximal Apical Deviation measurement in mm, obtained from the DIERS 4D Formetric Scanner

Secondary Outcome Measures

  1. Body Image Score [Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment]

    Average Body Image Score. Average score from 5 categories, scored from 1-10.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who completed the group treatment program in its entirety. Patients who have measurements obtained from all necessary time points. Patient who have Scoliosis and who have a primary thoracic curvature.
Exclusion Criteria:
  • Patient who did not complete treatment or all measurements obtained. Patients who underwent surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scoliosis SOS Clinic London United Kingdom E1 8AN

Sponsors and Collaborators

  • Scoliosis SOS Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scoliosis SOS Ltd.
ClinicalTrials.gov Identifier:
NCT05764499
Other Study ID Numbers:
  • ScoliosisSOS1
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023