NCT06503575

Brief Summary

Adolescent idiopathic scoliosis is the most common form of scoliosis. Although an increasing number of studies suggest that an abnormal sensory-motor integration critically contributes to the cause of adolescent idiopathic scoliosis , there is uncertainty about the level of the central nervous system explaining this dysfunction. Therefore, the planned master's thesis study aims to compare proprioception, tactile acuity, right-left reasoning ability, motor imagery ability, including the evaluation of body schema, which is a sensorimotor representation in adolescent idiopathic scoliosis patients with healthy individuals. In addition, the relationship of these markers with posture results, body perception and quality of life of individuals with adolescent idiopathic scoliosis will be investigated as a secondary aim.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 10, 2024

Last Update Submit

July 10, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • The two-point discrimination test

    The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception

    Baseline

  • Left/right discrimination (Lateralization)

    Right-Left Discrimination will be evaluated with Recognise™ applications (Back) developed by the "Neuro Orthopedic Institute".

    Baseline

  • Kinesthetic and Visual Imagery Questionnaire

    Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.

    Baseline

  • Lumbar proprioception test

    In both groups, thoracic and lumbar repositioning accuracy will be measured and evaluated using the dual inclinometer system.

    Baseline

  • Pressure Pain Threshold

    A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).

    Baseline

Secondary Outcomes (4)

  • 4D DIERS FORMETIC

    baseline

  • Body Image Disturbance Questionnaire--Scoliosis Version

    Baseline

  • Walter Reed Visual Assessment Scale

    Baseline

  • Scoliosis Research Society 22

    Baseline

Study Arms (2)

Patient with adolescent idiopathic scoliosis

Other: Assesment

Healthy control

Other: Assesment

Interventions

All assessments will be made

Healthy controlPatient with adolescent idiopathic scoliosis

Eligibility Criteria

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

Adolescent idiopathic scoliosis consulting a surgeon and adolescent healthy/untreated population consulting a surgeon

You may qualify if:

  • Diagnosis of Adolescent idiopathic scoliosis
  • Age ⩾19 years old
  • Curve severity over 10°

You may not qualify if:

  • History of spine surgery
  • Surgery or trauma
  • Secondary scoliosis
  • Unable to fill out the questionnaires or attend the physical examination,
  • History of musculoskeletal injury in the last six months
  • Known systematic and psychological illness
  • Use of prescription medication
  • Age ⩾ 19 years Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant
  • History of spine surgery
  • Spine deformity
  • Surgery or trauma
  • Primer and Secondary scoliosis
  • Unable to fill out the questionnaires or attend the physical examination,
  • History of musculoskeletal injury in the last six months
  • Known systematic and psychological illness
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acibadem University

Istanbul, +90, Turkey (Türkiye)

Location

Maslak Acıbadem

Istanbul, +90, Turkey (Türkiye)

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc, Prof. Nuray Alaca, Head of department Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

September 15, 2024

Primary Completion

January 15, 2025

Study Completion

July 15, 2025

Last Updated

July 16, 2024

Record last verified: 2024-07

Locations