NCT05969301

Brief Summary

This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. It consists of a short self-administered questionnaire which will be given to adolescents with scoliosis to complete. Relationships between young individuals' answers and health-related quality of life will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 16, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

July 16, 2023

Last Update Submit

September 27, 2023

Conditions

Keywords

Health-related quality of lifeAdolescentsMemoryScoliosisExercise

Outcome Measures

Primary Outcomes (1)

  • SRS-22 patient questionnaire

    Scoliosis Research Society-22 patient questionnaire. The maximum score in each domain (pain, function, self-image, and mental health) is 5 and minimum score is 1, with higher scores representing greater individual's quality of life.

    At the moment of the assessment

Interventions

The spinal esercises mainly include: active self-correction, strengthening spinal deep muscles while maintaining self-correction, segmentary stretching involving the limbs and back muscles, and postural task-oriented exercises (e.g. walking, standing, sitting).

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescent idiopathic scoliosis, which is a three-dimensional deformity of the spine and trunk occurring in healthy pubertal children.

You may qualify if:

  • a primary diagnosis of Adolescent Idiopathic Scoliosis determined by expert clinicians
  • ability to read and understand the Italian language

You may not qualify if:

  • any diagnosable cause of scoliosis
  • leg-length discrepancy of \> 1 cm
  • lower limb deformities interfering with spinal posture,
  • cardiac and/or respiratory dysfunction
  • systemic illness
  • previous spinal surgery,
  • cognitive impairment
  • refusal to adhere to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Rocca

Calosso, 14052, Italy

RECRUITING

Related Publications (2)

  • Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.

  • Monticone M, Baiardi P, Calabro D, Calabro F, Foti C. Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 Nov 15;35(24):E1412-7. doi: 10.1097/BRS.0b013e3181e88981.

MeSH Terms

Conditions

ScoliosisMotor Activity

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBehavior

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 16, 2023

First Posted

August 1, 2023

Study Start

September 1, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations