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NCT05433545 Clinical Trial

Adherence to Physiotherapy Scoliosis Specific Exercises in Adolescents With Spine Deformity: Development of a New Questionnaire

Spinal Deformity Clinical Trial

Official title:
Adherence to Physiotherapy Scoliosis Specific Exercises in Adolescents With Spine Deformity: Development of a New Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05433545
Other study ID # AdePSSE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 22, 2022
Est. completion date December 2024

Study information
Verified date May 2024
Source Istituto Scientifico Italiano Colonna Vertebrale
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. The development of a questionnaire in a Rasch environment and specifically developed for this population will ensure greater sensitivity and specificity of the questionnaire.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - aged between 10 and 18 years - adolescent idiopathic scoliosis of 10 ° Cobb or more - Scheuermann's kyphosis or idiopathic hyperkyphosis - prescription of specific exercises Exclusion Criteria: - positive neurological evaluation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Adolescents with spinal deformity will be asked to fill out a new questionnaire measuring the quality and quantity of adherence to specific physiotherapy exercises performed at home. Patients will be recruited at an outpatient service dedicated to the treatment of vertebral deformities during the monthly sessions with the physiotherapist

Locations
Country Name City State
Italy ISICO Milan Mi

Sponsors (1)
Lead Sponsor Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence to Physiotherapy Scoliosis Specific Exercises New questionnaire developped to assess quality and quantity of adherence to specific physiotherapy exercises performed at home patients with spinal deformity treated conservatively through study completion, an average of 1 year
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