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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05969301
Other study ID # 2023-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date February 29, 2024

Study information

Verified date September 2023
Source International Institute of Behavioral Medicines
Contact Barbara Rocca
Phone +393333653393
Email info.ellis.bm@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. Literature found out that a memory-experience difference exists between pleasant and unpleasant situations and young people are expected to capture memories more accurately when these, as voiced for instance by outcome measures of health-related quality of life, are at their worst- rather than at their best-perceived level. In Literature there are not studies which investigate the relationships between the memory of spinal exercises as for adolescents with idiopathic scoliosis and health-related quality of life. The study consists of a short self-administered questionnaire which will be given to young persons to complete. In more details, the survey is made of four questions collecting information on time to learn an exercise, time to perform an exercise, difficulty to do the exercise, commitment to perform the exercise. Further, participants will have to complete a self-administered health-related quality of life questionnaire, and namely the Scoliosis Research Society-22 patients questionnaire. Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between adolescents' answers and health-related quality of life questionnaire will be also evaluated. This study's usefulness relies on understanding which spinal exercises impact more on memory in order to increase a young persons' positive routines and improve their performance with rehabilitative programs, with the ultimate goal of growing their adherence to and satisfaction with treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers
Gender All
Age group 11 Years to 19 Years
Eligibility Inclusion Criteria: - a primary diagnosis of Adolescent Idiopathic Scoliosis determined by expert clinicians - ability to read and understand the Italian language Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Specific spinal exercises for idiopathic scoliosis
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).

Locations

Country Name City State
Italy Barbara Rocca Calosso

Sponsors (1)

Lead Sponsor Collaborator
International Institute of Behavioral Medicines

Country where clinical trial is conducted

Italy, 

References & 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 tr — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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