Scoliosis; AdolescencePSSENCT04215497
Effect of PSSE on Spine Reposition Sensation in Scoliosis
A study testing PSSE in people with Scoliosis; Adolescence and Spinal Curvatures, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The main aim of the investigator's study is to investigate the effect of Physiotherapeutic Scoliosis-Specific Exercises (PSSE) on spine joint reposition sense and also to investigate the effect of PSSE on vertebral rotation, pain, posture, body image and quality of life in Adolescent Idiopathic Scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Scoliosis; Adolescence, Spinal Curvatures, Proprioception
- What is being tested?
- PSSE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Sep 2019
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To have diagnosis of Adolescence Idiopathic Scoliosis
- To be in between 10-17 years
- To be the Cobb angle which determined in Anteroposterior graphy as between 10-45 degree
- To not having any other exercise attitude about scoliosis before.
- To attend the programme regularly
- To be volunteer about being participant to the study
Who cannot join
- Accompanying mental problems, rheumatologic, neuromuscular, cardiovascular, pulmonary history
- The presence of orthopedic problems or pain that prevent to do exercises
- Loss of vision and / or hearing
- Spinal surgery or tumor history
- Diseases in which exercise is contraindicated
- Patients with communication problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa, Faculty of Health Science
Istanbul
About this study
Official title: Effect of Physiotherapeutic Scoliosis-Specific Exercises on Spine Joint Reposition Sensation in Adolescent Idiopathic Scoliosis
The main aim of the investigator's study is to investigate the effect of Physiotherapeutic Scoliosis-Specific Exercises (PSSE) on spine joint reposition sense and also to investigate the effect of PSSE on vertebral rotation, pain, posture, body image and quality of life in Adolescent Idiopathic Scoliosis (AIS).
Twenty-six patients with AIS will randomly allocated to two groups. 'Schroth' exercises will apply to the PSSE group for 8 weeks (16 sessions). The control group wiil teach basic elements. Patients' spinal pain (Visual Analogue Scale), posture parameters (PostureScreen Mobile, Posterior Trunk Asymmetry Index (POTSI) and Anterior Trunk Asymmetry Index (ATSI)), cosmetic perception (Walter Reed Visual Evaluation Scale (WRVAS)), joint reposition sensations (dual-inclinometer), quality of life (Pediatric Quality of Life Scale and SRS-22) will assess at the first session and at the end of 8 weeks.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine which is seen in 1-3% of the adolescent population and mostly in girls. Lateral curvature in the frontal plane, axial rotation in the horizontal plane, and kyphosis and lordosis in the sagittal plane are observed. Etiology-related factors of AIS are genetic factors, abnormal neurophysiological functions occurring in the nervous system, hormones, metabolic dysfunction, abnormal skeletal development, biomedical factors, environmental and lifestyle factors.
The vertical position is associated with cortical, subcortical and medullar integration, and postural control based on bodily input.
Approaches as observation, patient education, scoliosis-specific physiotherapy exercises (PSSE), inpatient rehabilitation, electrical stimulation, manipulative applications and brace application are the conservative treatments of scoliosis. PSSE, which includes three-dimensional correction, daily life activities training, posture stabilization and patient education, is a method recommended by Society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) for the conservative treatment of scoliosis. The Schroth 'method is one of the PSSE methods that use three-dimensional postural correction mechanisms. The main goal of the Schroth 'exercises is to reduce the asymmetric load on the spine by using posture variations specific to the patient's curvature. There are no studies i regarding the effect of PSSE on changing proprioceptive neural mechanisms evaluated in the etiopathogenesis of scoliosis.
- Being tested
- PSSE
- Keywords
- scoliosis, PSSE, proprioception, joint reposition
- Medical subject headings
- Scoliosis, Spinal Curvatures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSSEOther
Physiotherapeutic Scoliosis-Specific Exercises (PSSE) group will receive exercise for 30-40 mins in a day, twice in a week, totally 8 weeks and 16 hours.
Control group will be taught the basic elements of corrective exercises and want them to do the practising during 8 weeks at home.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapeutic Scoliosis-Specific Exercises | Experimental | PSSE group will receive corrective exercise for scoliosis Receives: Other: PSSE |
| Control | No intervention | Control group will be taken to the queue list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of spine joint position reproduction
Acumar™ Dual Inclinometer:
The subjects will be asked to stay at the reference position for three seconds and then move to the upright position and then go back to the reference angle with their eyes closed. The absolute difference between the two positions in degrees will be noted as the reposition error value. The decrease in the reposition error value is considered as the improvement in the reposition sense.
Measured: 8 week
Secondary outcomes (7)
Spinal pain assessment
Visual Analogue Scale (VAS):
It is used to quantify the pain intensity of patients. The condition that there is no pain is expressed as 0, and the condition that there is too much pain to be tolerated is expressed as 10.
Measured: 8 week
Frontal-sagittal plan posture evaluation
"PostureScreen Mobile" Application:
Frontal and sagittal plan posture evaluation will be calculated by marking the reference points on the anterior, posterior and lateral photographs of the patient in "PostureScreen Mobile" application. The total displacement values in the anterior, posterior and lateral directions for postural impairment will be noted in "cm". Decreasing the total displacement values is considered as an improvement in postural parameters.
Measured: 8 week
Body Symmetry
Posterior Trunk Asymmetry Index (POTSI):
The Posterior Trunk Asymmetry Index parameter is defined as the sum of the six indices: the three frontal plane asymmetry index (C7, axilla folds and waist lines) and the three frontal plane height difference index (acromions, axilla folds and waist lines). The Posterior Trunk Asymmetry Index score is calculated by placing the indices on the posterior photo of the patient. The Posterior Trunk Asymmetry Index score, which represents full symmetry, is '0' and the increase in score indicates increased trunk asymmetry.
Measured: 8 week
Body Symmetry
Anterior Trunk Asymmetry Index (ATSI):
It is defined as the sum of the six indices determined on the patient's anterior photo: three frontal plane asymmetry indices (stern notch, axilla folds and waist lines) and three frontal plane plane height difference indices (acromions, axilla folds and waist lines). The Anterior Trunk Asymmetry Index score is calculated by placing the indices in the formula. The Anterior Trunk Asymmetry Index score, which represents full symmetry, is '0' and the increase in score indicates increased trunk asymmetry.
Measured: 8 week
Deformity perception assessment
The Walter Reed Visual Assessment Scale (WRVAS):
It is designed to understand the visual change caused by scoliosis and evaluates deformity under 7 headings. There are 5 different pictures that show different degrees of deformity. Each deformity is scored from 1 to 5; "1" is the best, "5" is the worst. The total score is obtained by summing the scores from all titles and dividing them by 7. The score ranges from 1 to 5, and a higher total score means that the perceived deformity is worse.
Measured: 8 week
Health-related quality of life assessment
Pediatric Quality of Life Inventory:
This inventory consists of two forms: child and family. Both forms included physical functions (8 items), emotional functions (5 items), social functions (5 items) and school functions (5 items). Scoring is done between 0-5 for each question. The total score of the inventory ranges between 0-100 points. The higher the score represents better the health-related quality of life.
Measured: 8 week
Quality of life assessment for scoliosis: Scoliosis Research Society-22 Questionnaire (SRS-22)
Scoliosis Research Society-22 Questionnaire (SRS-22):
The questionnaire assesses five domains: function, pain, personal image, mental health (five questions each) and treatment satisfaction (two questions). Each question is scored between 1 (worst) and 5 (best). In the interrogation whose total score ranged from 22 to 111, the high score indicates that the quality of life for scoliosis is better.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Oct 2018
- Primary completion25 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215497
- Sponsor's protocol ID
- 2018/1500
- Acronym
- PSSE
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapeutic Scoliosis-Specific Exercises on Spine Joint Reposition Sensation in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04215497
- Acronym / sponsor ID
- PSSE / 2018/1500
- Keywords
- scoliosis, PSSE, proprioception, joint reposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 2 Jan 2020 (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.
The main aim of the investigator's study is to investigate the effect of Physiotherapeutic Scoliosis-Specific Exercises (PSSE) on spine joint reposition sense and also to investigate the effect of PSSE on vertebral rotation, pain, posture, body image and quality of life in Adolescent Idiopathic Scoliosis (AIS).
Twenty-six patients with AIS will randomly allocated to two groups. 'Schroth' exercises will apply to the PSSE group for 8 weeks (16 sessions). The control group wiil teach basic elements. Patients' spinal pain (Visual Analogue Scale), posture parameters (PostureScreen Mobile, Posterior Trunk Asymmetry Index (POTSI) and Anterior Trunk Asymmetry Index (ATSI)), cosmetic perception (Walter Reed Visual Evaluation Scale (WRVAS)), joint reposition sensations (dual-inclinometer), quality of life (Pediatric Quality of Life Scale and SRS-22) will assess at the first session and at the end of 8 weeks.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine which is seen in 1-3% of the adolescent population and mostly in girls. Lateral curvature in the frontal plane, axial rotation in the horizontal plane, and kyphosis and lordosis in the sagittal plane are observed. Etiology-related factors of AIS are genetic factors, abnormal neurophysiological functions occurring in the nervous system, hormones, metabolic dysfunction, abnormal skeletal development, biomedical factors, environmental and lifestyle factors.
The vertical position is associated with cortical, subcortical and medullar integration, and postural control based on bodily input.
Approaches as observation, patient education, scoliosis-specific physiotherapy exercises (PSSE), inpatient rehabilitation, electrical stimulation, manipulative applications and brace application are the conservative treatments of scoliosis. PSSE, which includes three-dimensional correction, daily life activities training, posture stabilization and patient education, is a method recommended by Society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) for the conservative treatment of scoliosis. The Schroth 'method is one of the PSSE methods that use three-dimensional postural correction mechanisms. The main goal of the Schroth 'exercises is to reduce the asymmetric load on the spine by using posture variations specific to the patient's curvature. There are no studies i regarding the effect of PSSE on changing proprioceptive neural mechanisms evaluated in the etiopathogenesis of scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapeutic Scoliosis-Specific Exercises | Experimental | Other: PSSEPSSE group will receive corrective exercise for scoliosis |
| Control | No intervention | –Control group will be taken to the queue list. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- To have diagnosis of Adolescence Idiopathic Scoliosis
- To be in between 10-17 years
- To be the Cobb angle which determined in Anteroposterior graphy as between 10-45 degree
- To not having any other exercise attitude about scoliosis before.
- To attend the programme regularly
Key exclusion criteria (6 listed)
- Accompanying mental problems, rheumatologic, neuromuscular, cardiovascular, pulmonary history
- The presence of orthopedic problems or pain that prevent to do exercises
- Loss of vision and / or hearing
- Spinal surgery or tumor history
- Diseases in which exercise is contraindicated
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 |
|---|---|---|
| PSSEPhysiotherapeutic Scoliosis-Specific Exercises (PSSE) group will receive exercise for 30-40 mins in a day, twice in a week, totally 8 weeks and 16 hours. Control group will be taught the basic elements of corrective exercises and want them to do the practising during 8 weeks at home. | Other | Physiotherapeutic Scoliosis-Specific Exercises |
Primary outcome
Evaluation of spine joint position reproduction
Time frame: 8 week
Acumar™ Dual Inclinometer: The subjects will be asked to stay at the reference position for three seconds and then move to the upright position and then go back to the reference angle with their eyes closed. The absolute difference between the two positions in degrees will be noted as the reposition error value. The decrease in the reposition error value is considered as the improvement in the reposition sense.
7 secondary outcomes
Spinal pain assessment
Time frame: 8 week
Frontal-sagittal plan posture evaluation
Time frame: 8 week
Body Symmetry
Time frame: 8 week
Body Symmetry
Time frame: 8 week
Deformity perception assessment
Time frame: 8 week
Health-related quality of life assessment
Time frame: 8 week
Quality of life assessment for scoliosis: Scoliosis Research Society-22 Questionnaire (SRS-22)
Time frame: 8 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 18 Jan 2020.
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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 PSSE in people with Scoliosis; Adolescence and Spinal Curvatures, run by Istanbul University - Cerrahpasa 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 6 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 18 Jan 2020. 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?
Evaluation of spine joint position reproduction (time frame: 8 week). 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 18 Jan 2020.