NCT05433545

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2.4 years

First QC Date

June 21, 2022

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Adherence to specific physiotherapy exercises

Other: Questionnaire

Interventions

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

Adherence to specific physiotherapy exercises

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents with spinal deformity treated with Physiotherapy Scoliosis Specific Exercises

You may qualify if:

  • aged between 10 and 18 years
  • adolescent idiopathic scoliosis of 10 ° Cobb or more
  • Scheuermann's kyphosis or idiopathic hyperkyphosis
  • prescription of specific exercises

You may not qualify if:

  • positive neurological evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Massimiliano Vanossi, PT

    Istituto Scientifico Italiano Colonna Vertebrale

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

March 22, 2022

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

The raw data will be shared on a repositiry

Locations