Scoliosis IdiopathicNCT05326256
Trunk Proprioception in Adolescent Idiopathic Scoliosis
A study testing Exercise training- PSSE and Exercise training- PSSE with vestibular exercises in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Aims of this clinical research: To investigate trunk proprioception in all three planes in individuals with adolescent idiopathic scoliosis (AIS), To investigate the pelvis orientation sense in all three planes in individuals with adolescent idiopathic scoliosis, To investigate whether trunk proprioception and pelvis… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Adolescence
- What is being tested?
- Exercise training- PSSE and Exercise training- PSSE with vestibular exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 17 Apr 2023
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosed with adolescent idiopathic scoliosis,
- Aged 10-18,
- Have Physiotherapy Scoliosis Specific Exercises (PSSE) indications,
- Individuals and her/his parents volunteered to participate in the study.
Who cannot join
- Any contraindication that will prevent the individual from participating to exercise training,
- Have had spinal surgery before,
- Have any mental problems,
- The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.),
- The apex of the curve is thoracal-6 vertebrae and above,
- Any neurological, psychiatric, muscular, rheumatic, renal, cardiovascular, pulmonary, tumoral, or orthopedic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on Trunk Proprioception in Adolescent Idiopathic Scoliosis
Aims of this clinical research:
- To investigate trunk proprioception in all three planes in individuals with adolescent idiopathic scoliosis (AIS),
- To investigate the pelvis orientation sense in all three planes in individuals with adolescent idiopathic scoliosis,
- To investigate whether trunk proprioception and pelvis orientation sense are improved with Physiotherapy Scoliosis Specific Exercises (PSSE) in AIS,
- To investigate whether trunk proprioception and pelvis orientation sense are improved with vestibular exercise training to be added to PSSE exercises in AIS,
- Comparison of the effects of different exercise training on trunk proprioception and pelvis orientation sense in AIS
- To examine the parameters that may be associated with the improvement of trunk proprioception of different exercise training (health-related quality of life, perception of cosmetic deformity, scoliosis-related clinical features such as Cobb angle, axial trunk rotation, curve type, etc.).
Read the detailed description
This clinical study includes examining trunk proprioception and pelvis orientation in all three planes, pain, flexibility, health-related quality of life, perception of cosmetic deformity, dynamic balance, and the effectiveness of different exercise training in individuals aged 10-18 years with a diagnosis of adolescent idiopathic scoliosis and who have PSSE indication.
As the control group; healthy peers with the same characteristics as the exercise groups will be included and they have a negative result of Adam's forward bending test, they do not have any postural disorders.
As a result of the randomization to be applied to the individuals, they will be divided into two groups: PSSE exercise group and vestibular exercise group (vestibular exercises added to PSSE exercises).
Initial assessments will be given to all individuals. Exercise training groups will participate in a 45-minute exercise session with the supervisor, twice a week for 12 weeks. Before exercise training, individuals and their parents will be informed about education and daily life activities.
Apart from the exercises performed under the supervision of a physiotherapist, individuals will be given a home exercise program, and the family and the individual will be asked to keep a diary to evaluate their compliance with the exercise, and the exercise compliance will be evaluated with a phone call every week.
When the exercise training is completed, the training groups will be evaluated as post-training assessments.
In the statistical analysis of data; the values of the control group will be used as normative and will be compared with the data of individuals with scoliosis. The data of the training groups before and after the training program will be compared, and the data of the different exercise groups will be compared with each other.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Being tested
- Exercise training- PSSE, Exercise training- PSSE with vestibular exercises
- Keywords
- scoliosis, adolescent, proprioception, exercise
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training- PSSEOther
Barcelona Scoliosis Physical Therapy School (BSPTS) method exercises
Exercise training- PSSE with vestibular exercisesOther
Vestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises
| Study group | Role | What they receive |
|---|---|---|
| PSSE Group | Experimental | Physiotherapy Scoliosis Specific Exercises (PSSE), 45-minute exercise session with the supervisor, twice a week for 12 weeks Receives: Other: Exercise training- PSSE |
| Vestibular Exercise Group | Experimental | Vestibular exercises to be added to PSSE exercises, 45-minute exercise session with the supervisor, twice a week for 12 weeks Receives: Other: Exercise training- PSSE with vestibular exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Trunk Proprioception
Thoracic position sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the trunk at the level of C7-T1 vertebrae. The individual to be measured is standing, for example, the individual to flexion the trunk to 30 degrees and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.
Measured: Baseline, after the 12 weeks of exercise training
Change of Pelvis Orientation Sense
Pelvis orientation sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the lumbar area at the level of the S1 vertebrae. The individual to be measured is standing, performs the anterior-posterior pelvic tilt motion in her/his pelvis, and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.
Measured: Baseline, after the 12 weeks of exercise training
Change of Dynamic balance, spatial orientation
Assement of dynamic balance with Fukuda-Utenberger stepping test
Measured: Baseline, after the 12 weeks of exercise training
Change of Cosmetic Deformity Perception
Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)
Measured: Baseline, after the 12 weeks of exercise training
Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist
Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)
Measured: Baseline, after the 12 weeks of exercise training
Change of Health-Related Quality of Life
Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire
Measured: Baseline, after the 12 weeks of exercise training
Change of Body Asymmetry
Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)
Measured: Baseline, after the 12 weeks of exercise training
Secondary outcomes (7)
Enroll of the Cobb Angle
The Cobb angle is measured on postero-anterior full spine radiographs as the standard method of quantifying the amount of lateral deviation of the spine.
Measured: Baseline, after the 12 weeks of exercise training
Enroll of the Risser sign
Risser sign is observed that the state of ossification of the iliac apophysis on radiographs as the standard method of quantifying the skeletal maturity.
Measured: Baseline, after the 12 weeks of exercise training
Enroll of the clinical features of scoliosis
The classification of Lenke, SRS (Scoliosis Research Society), and BSPTS (Barcelona Scoliosis Physical Therapy School) are determined according to individual's radiographs, results of Adam's forward bending test, and orientation of the trunk position regarding pelvis.
Measured: Baseline, after the 12 weeks of exercise training
Change of Angle of Trunk Rotation
Angle of trunk rotation is measured with scoliometer on Adam's forward bending test regarding the size of the hump of the trunk.
Measured: Baseline, after the 12 weeks of exercise training
Change of Pain
Pain assessment with Visual Analogue Scale
Measured: Baseline, after the 12 weeks of exercise training
Change of Flexibility
Flexibility assessment with forward and side bending test
Measured: Baseline, after the 12 weeks of exercise training
Evaluation of exercise training compliance
The compliance of the home exercise program is followed by weekly phone calls with the individual and their parents. At the end of the research, the amount of exercise compliance of the individuals will be determined according to the calculation of recommended and performing exercises.
Measured: Once a week for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start2 Feb 2022
- Primary completion2 Feb 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Karatel, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326256
- Sponsor's protocol ID
- 2022/008
- Status last verified
- Apr 2023
- First submitted
- 24 Feb 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on Trunk Proprioception in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05326256
- Acronym / sponsor ID
- 2022/008
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Keywords
- scoliosis, adolescent, proprioception, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 13 Apr 2022 (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.
Aims of this clinical research:
- To investigate trunk proprioception in all three planes in individuals with adolescent idiopathic scoliosis (AIS),
- To investigate the pelvis orientation sense in all three planes in individuals with adolescent idiopathic scoliosis,
- To investigate whether trunk proprioception and pelvis orientation sense are improved with Physiotherapy Scoliosis Specific Exercises (PSSE) in AIS,
- To investigate whether trunk proprioception and pelvis orientation sense are improved with vestibular exercise training to be added to PSSE exercises in AIS,
- Comparison of the effects of different exercise training on trunk proprioception and pelvis orientation sense in AIS
- To examine the parameters that may be associated with the improvement of trunk proprioception of different exercise training (health-related quality of life, perception of cosmetic deformity, scoliosis-related clinical features such as Cobb angle, axial trunk rotation, curve type, etc.).
Detailed description
This clinical study includes examining trunk proprioception and pelvis orientation in all three planes, pain, flexibility, health-related quality of life, perception of cosmetic deformity, dynamic balance, and the effectiveness of different exercise training in individuals aged 10-18 years with a diagnosis of adolescent idiopathic scoliosis and who have PSSE indication.
As the control group; healthy peers with the same characteristics as the exercise groups will be included and they have a negative result of Adam's forward bending test, they do not have any postural disorders.
As a result of the randomization to be applied to the individuals, they will be divided into two groups: PSSE exercise group and vestibular exercise group (vestibular exercises added to PSSE exercises).
Initial assessments will be given to all individuals. Exercise training groups will participate in a 45-minute exercise session with the supervisor, twice a week for 12 weeks. Before exercise training, individuals and their parents will be informed about education and daily life activities.
Apart from the exercises performed under the supervision of a physiotherapist, individuals will be given a home exercise program, and the family and the individual will be asked to keep a diary to evaluate their compliance with the exercise, and the exercise compliance will be evaluated with a phone call every week.
When the exercise training is completed, the training groups will be evaluated as post-training assessments.
In the statistical analysis of data; the values of the control group will be used as normative and will be compared with the data of individuals with scoliosis. The data of the training groups before and after the training program will be compared, and the data of the different exercise groups will be compared with each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSSE Group | Experimental | Other: Exercise training- PSSEPhysiotherapy Scoliosis Specific Exercises (PSSE), 45-minute exercise session with the supervisor, twice a week for 12 weeks |
| Vestibular Exercise Group | Experimental | Other: Exercise training- PSSE with vestibular exercisesVestibular exercises to be added to PSSE exercises, 45-minute exercise session with the supervisor, twice a week for 12 weeks |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with adolescent idiopathic scoliosis,
- Aged 10-18,
- Have Physiotherapy Scoliosis Specific Exercises (PSSE) indications,
- Individuals and her/his parents volunteered to participate in the study.
Key exclusion criteria (6 listed)
- Any contraindication that will prevent the individual from participating to exercise training,
- Have had spinal surgery before,
- Have any mental problems,
- The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.),
- The apex of the curve is thoracal-6 vertebrae and above,
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 |
|---|---|---|
| Exercise training- PSSEBarcelona Scoliosis Physical Therapy School (BSPTS) method exercises | Other | PSSE Group |
| Exercise training- PSSE with vestibular exercisesVestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises | Other | Vestibular Exercise Group |
Primary outcome
Change of Trunk Proprioception
Time frame: Baseline, after the 12 weeks of exercise training
Thoracic position sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the trunk at the level of C7-T1 vertebrae. The individual to be measured is standing, for example, the individual to flexion the trunk to 30 degrees and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.
Change of Pelvis Orientation Sense
Time frame: Baseline, after the 12 weeks of exercise training
Pelvis orientation sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the lumbar area at the level of the S1 vertebrae. The individual to be measured is standing, performs the anterior-posterior pelvic tilt motion in her/his pelvis, and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.
Change of Dynamic balance, spatial orientation
Time frame: Baseline, after the 12 weeks of exercise training
Assement of dynamic balance with Fukuda-Utenberger stepping test
Change of Cosmetic Deformity Perception
Time frame: Baseline, after the 12 weeks of exercise training
Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)
Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist
Time frame: Baseline, after the 12 weeks of exercise training
Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)
Change of Health-Related Quality of Life
Time frame: Baseline, after the 12 weeks of exercise training
Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire
Change of Body Asymmetry
Time frame: Baseline, after the 12 weeks of exercise training
Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)
7 secondary outcomes
Enroll of the Cobb Angle
Time frame: Baseline, after the 12 weeks of exercise training
Enroll of the Risser sign
Time frame: Baseline, after the 12 weeks of exercise training
Enroll of the clinical features of scoliosis
Time frame: Baseline, after the 12 weeks of exercise training
Change of Angle of Trunk Rotation
Time frame: Baseline, after the 12 weeks of exercise training
Change of Pain
Time frame: Baseline, after the 12 weeks of exercise training
Change of Flexibility
Time frame: Baseline, after the 12 weeks of exercise training
Evaluation of exercise training compliance
Time frame: Once a week for 12 weeks
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 19 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 Exercise training- PSSE and Exercise training- PSSE with vestibular exercises in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Hasan Kalyoncu 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 4 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 19 Apr 2023. 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?
Change of Trunk Proprioception (time frame: Baseline, after the 12 weeks of exercise training). The study lists 7 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 19 Apr 2023.