NCT06817538

Brief Summary

In this study, "Single Task" and "Dual Task" groups will be formed in individuals aged 10-18 years with scoliosis. For 12 weeks, scoliosis-specific three-dimensional exercises will be applied to both groups. The Single Task group will receive only motor exercise training, while the Dual Task group will receive both motor and cognitive exercise training. At the end of the study, the dual-task performance of both groups will be evaluated and the effects of dual task training on individuals with scoliosis will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 16, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

May 16, 2024

Last Update Submit

April 14, 2025

Conditions

Keywords

adolescentdual taskscoliosisgait parameters

Outcome Measures

Primary Outcomes (6)

  • Single Motor - Cadence

    10 meter walking test. Measurements will begin with the participant's first step from the starting line and will end as they cross the finish line. Each participant will complete three trials, during which the step count and duration will be recorded. Based on these evaluations cadence (steps/min) will be calculated.

    From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)

  • Single Motor - Step Lengths

    10 meter walking test. Measurements will begin with the participant's first step from the starting line and will end as they cross the finish line. Each participant will complete three trials, during which the step count and duration will be recorded. Based on these evaluations step lengths (m) will be calculated.

    From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)

  • Single Motor - Walking Speed

    10 meter walking test. Measurements will begin with the participant's first step from the starting line and will end as they cross the finish line. Each participant will complete three trials, during which the step count and duration will be recorded. Based on these evaluations, walking speed (m/min) will be calculated.

    From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)

  • Single Cognitive

    Stroop Test

    From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)

  • Dual-Task ( Number)

    Giving specific cognitive tasks during a 10m walk. These cognitive tasks will be counting backwards in 7's from a random number between 50-100.

    From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week).

  • Dual-Task (Letter)

    Participants will read a 5-letter word backward during a 10-meter walk. Each word will be provided randomly, and participants will be instructed to articulate the letters of the word in reverse order while walking.

    From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week).

Secondary Outcomes (2)

  • Body Asymmetry and Posture Assessments

    Baseline measurements conducted at the initial assessment. Participants will undergo a 12-week exercise intervention, with one session per week. Post-treatment assessments will be conducted immediately after completing the 12 sessions at the 12th week.

  • Scoliosis-specific assessments 2

    Baseline measurements conducted at the initial assessment. Participants will undergo a 12-week exercise intervention, with one session per week. Post-treatment assessments will be conducted immediately after completing the 12 sessions at the 12th week.

Study Arms (2)

Single Task Group

OTHER

Control

Behavioral: Physiotherapy/Exercise Program

Dual Task Group

OTHER

Study

Behavioral: Physiotherapy/Exercise Program

Interventions

Arm 1: Scoliosis-Specific Exercises Combined with Dual-Task Cognitive Training Participants with idiopathic scoliosis in this group received scoliosis-specific physiotherapeutic exercises combined with dual-task cognitive training. The intervention included motor exercises performed on balance boards and stability trainers to enhance postural control. While engaging in these motor exercises, participants simultaneously performed cognitive tasks such as word recall, identifying cities or countries starting with a given letter, and other memory-based games. This dual-task approach aimed to improve both motor and cognitive functions. Arm 2: Scoliosis-Specific and Motor Exercises Only Participants with idiopathic scoliosis in this group performed scoliosis-specific physiotherapeutic exercises along with motor exercises aimed at improving postural stability. The motor exercises were conducted using balance boards and stability trainers, focusing solely on physical performance without the

Dual Task GroupSingle Task Group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Individuals between the ages of 10-16
  • Individuals with idiopathic scoliosis
  • Individuals with curve degrees between 10 and 40
  • Individuals with a body mass index of less than 30 kg\\m2.
  • Be willing to participate in the tests and have the cognitive ability to complete the tests.

You may not qualify if:

  • Having other types of scoliosis other than idiopathic scoliosis
  • Individuals with previous scoliosis or any spine-related conservative treatment or surgery
  • Acute (fracture, surgery); cardiovascular system (heart failure, arrhythmia...); nervous system diseases (epilepsy, vertigo...); sensory organs (vision or hearing loss...); musculoskeletal disorders (rheumatism, hypermobility syndrome...)
  • Taking any regular medication that may affect balance (ssri, psycholeptic, anti-epileptic medication...)
  • Playing sports at a professional level
  • Using a brace, starting to use a brace

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy and Rehabilitation, Hacettepe

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-drug clinical research and method comparison clinical research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 16, 2024

First Posted

February 10, 2025

Study Start

December 31, 2024

Primary Completion

March 30, 2025

Study Completion

March 31, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations