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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Deformity; Adherence, Treatment
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20141
      • Recruiting
      • ISICO
      • Contact: Massimiliano Vanossi, PT; Phone Number: +3902 8416 1700; Email: massimiliano.vanossi@isico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents with spinal deformity treated with Physiotherapy Scoliosis Specific Exercises

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adherence to specific physiotherapy exercises	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale
• Investigators: Principal Investigator: Massimiliano Vanossi, PT, Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis
• Other Study ID Numbers: AdePSSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The raw data will be shared on a repositiry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No