Idiopathic ScoliosisNCT06817538
Investigation of the Effects of Dual Task Training on Dual Task Performance in Individuals With Scoliosis
A study testing Physiotherapy/Exercise Program in people with Idiopathic Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Physiotherapy/Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Physiotherapy and Rehabilitation, Hacettepe
Ankara, 06000
About this study
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.
Read the detailed description
Scoliosis is a term used to describe changes in the shape and position of the spine and chest cage. Essentially, scoliosis involves lateral deviation and rotations of the vertebrae, accompanied by changes in the sagittal plane, creating a three-dimensional deformity. The progressive nature of scoliotic deformity underscores the importance of controlling these components through conservative methods. Without control, scoliosis can lead to postural, balance, and locomotor disorders due to compromised sensory integrity and inadequate proprioceptive feedback. Despite compromised postural control and continuity in individuals with Adolescent Idiopathic Scoliosis (AIS), maintaining daily life activities and body orientation is crucial for controlling the progression of scoliosis. The daily routine of individuals with AIS often involves simultaneous engagement in postural control alongside other daily activities. These routines and exercises frequently incorporate dual-task components. Our study aims to examine the effectiveness of single-task and dual-task walking and balance exercises in individuals with scoliosis, as well as their contributions to scoliosis-specific assessments
- Conditions
- Idiopathic Scoliosis
- Being tested
- Physiotherapy/Exercise Program
- Keywords
- adolescent, dual task, scoliosis, gait parameters
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy/Exercise ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Single Task Group | Other | Control Receives: Behavioral: Physiotherapy/Exercise Program |
| Dual Task Group | Other | Study Receives: Behavioral: Physiotherapy/Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)
Single Cognitive
Stroop Test
Measured: 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.
Measured: 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.
Measured: 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
Anterior and Posterior Trunk Symmetry Index
Measured: 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
Anterior Trunk Rotation. The ATR is measured with the help of a scoliometer (inclinometer), a scoliosis measuring device, which evaluates the rotation of the trunk in degrees with the patient in a forward-bent position (Adam's Test position)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start31 Dec 2024
- Primary completion30 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-drug clinical research and method comparison clinical research
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Yagci (Gür), Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817538
- Sponsor's protocol ID
- HUTez_001
- Status last verified
- Apr 2025
- First submitted
- 16 May 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Dual Task Training on Dual Task Performance in Individuals With Scoliosis
- ClinicalTrials.gov ID
- NCT06817538
- Acronym / sponsor ID
- HUTez_001
- Conditions
- Idiopathic Scoliosis
- Keywords
- adolescent, dual task, scoliosis, gait parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scoliosis is a term used to describe changes in the shape and position of the spine and chest cage. Essentially, scoliosis involves lateral deviation and rotations of the vertebrae, accompanied by changes in the sagittal plane, creating a three-dimensional deformity. The progressive nature of scoliotic deformity underscores the importance of controlling these components through conservative methods. Without control, scoliosis can lead to postural, balance, and locomotor disorders due to compromised sensory integrity and inadequate proprioceptive feedback. Despite compromised postural control and continuity in individuals with Adolescent Idiopathic Scoliosis (AIS), maintaining daily life activities and body orientation is crucial for controlling the progression of scoliosis. The daily routine of individuals with AIS often involves simultaneous engagement in postural control alongside other daily activities. These routines and exercises frequently incorporate dual-task components. Our study aims to examine the effectiveness of single-task and dual-task walking and balance exercises in individuals with scoliosis, as well as their contributions to scoliosis-specific assessments
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-drug clinical research and method comparison clinical research
| Arm | Type | Receives |
|---|---|---|
| Single Task Group | Other | Behavioral: Physiotherapy/Exercise ProgramControl |
| Dual Task Group | Other | Behavioral: Physiotherapy/Exercise ProgramStudy |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy/Exercise ProgramArm 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 | Behavioural | Dual Task Group, Single Task Group |
Primary outcome
Single Motor - Cadence
Time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)
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.
Single Motor - Step Lengths
Time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)
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.
Single Motor - Walking Speed
Time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)
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.
Single Cognitive
Time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)
Stroop Test
Dual-Task ( Number)
Time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week).
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.
Dual-Task (Letter)
Time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week).
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.
2 secondary outcomes
Body Asymmetry and Posture Assessments
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy/Exercise Program in people with Idiopathic Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Motor - Cadence (time frame: From baseline assessment to post-intervention at 12 weeks (after 12 exercise sessions, one session per week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.