Scoliosis IdiopathicNCT05392504
Effects of Core Stabilization Exercises vs. Schroth's Program on Posture and Quality of Life in Females With Scoliosis.
A study testing Core stability exercise and Scroth's Program in people with Scoliosis Idiopathic, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The objective of this study is to compare the effects of core stabilization exercises versus schroth's program on posture and quality of life in females with idiopathic scoliosis Read more about this study
- Who is it for?
- Ages 19 to 30 years, women only
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Core stability exercise and Scroth's Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jun 2022to 22 Sep 2022
- 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 19 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females only
- Positive Forward bend test (FBT)
- Idiopathic scoliosis
- Cob's angle 10°-26°
- Age group ranged between 19-30 yrs.
- Normal BMI (18.5-24.9 kg/m2)
- Chronic Scoliosis patients
- Riser Sign 4-5
Who cannot join
- Subjects with any surgical intervention for scoliosis
- Pregnant women
- Subjects with any serious health condition
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
New canal medical center
Lahore, Punjab Province, 54000
Pakistan Society for the Rehabilitation of the Disabled
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Core Stabilization Exercises Versus Schroth's Program on Posture and Quality of Life in Females With Idiopathic Scoliosis.
The objective of this study is to compare the effects of core stabilization exercises versus schroth's program on posture and quality of life in females with idiopathic scoliosis
Read the detailed description
Scoliosis is a 3 dimension condition that effects most of our population specifically females. It is not only a bend in your spine but according to new research, its also twisting it. The curvature effects the effected individual physical and the social anxiety due to appearance and a continues state of lethargy effects their quality of life immensely. The posture is poorly effected along with a visual appearance. Often someone with scoliosis might find good posture difficult. Often someone with scoliosis will lean forwards and to the side either slightly or a lot. They will often try to avoid doing this, which can lead to slightly bent knees and the pelvis tilting backwards. Scoliosis is often defined as spinal curvature in the "coronal" (frontal) plane. While the degree of curvature is measured on the coronal plane, scoliosis is actually a more complex, three-dimensional problem which involves all 3 planes. It is defined by the Cobb's angle of spine curvature in the coronal plane and is often accompanied by vertebral rotation in the transverse plane and hypokyphosis in the sagittal plane. These abnormalities in the spine, costal-vertebral joints, and the rib cage produce a 'convex' and 'concave' hemithorax.
Only females having idiopathic scoliosis with cob's angle 10°-26° with age ranging between 19-30 are included and any subjects with surgical interventions are excluded.
Population will be divided in to two groups. One group will perform scroth exercises for 4 weeks and the other group will perform core straightening exercises for 4 weeks each. Once the time period is complete, the posture will be measured using pelvic and shoulder goniometers to check the level of tilt and for quality of lifestyle, we will be using quality of life (Scoliosis Research Society-22 questionnaire)
- Conditions
- Scoliosis Idiopathic
- Being tested
- Core stability exercise, Scroth's Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exerciseOther
The core stability training consist of three phases
Scroth's ProgramOther
The Schroth program include exercises for rotational breathing, spinal elongation, deflexion, stretching, de-rotation, and strengthening
| Study group | Role | What they receive |
|---|---|---|
| Core stability exercise | Experimental | The core stability training consist of three phases. The first and second phases each will last for three weeks in total, and the third phase will take place in four weeks. Each training session will begin with 10 minutes of warm-up exercises and finish with 10 minutes of cool-down exercises; both warm-up and cool-down exercises includes breathing and stretching exercises. The number of repetitions will be adjusted according to the participant's exercise tolerance.
During the first week of each phase, the number of repetitions of each exercise will be 7-10, and this will progress to 10-15 based on the patient's physical tolerance. Receives: Other: Core stability exercise |
| Scroth's program | Active comparator | The Schroth program include exercises for rotational breathing, spinal elongation, de-flexion, stretching, de-rotation, and strengthening, and these exercises are performed to improve the curvature, muscle strength, and endurance of postural muscles. During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support. The intensity of the Schroth exercises will gradually increased depending on the patient's improvement in exercise performance by decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises Receives: Other: Scroth's Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Research Society-22 questionnaire
It is a standardized questionnaire designed by scoliosis research society to measure the quality of life in scoliosis patients. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jun 2022
- Primary completion15 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Mehjabeen, Ms, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392504
- Sponsor's protocol ID
- REC/RCR & AHS/22/0519
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dela Merced P, Vazquez Colon C, Mirzada A, Oke A, Gal Z, Cheng J, Oetgen MM, Martin B, Pestieau SR, Cronin JA. Association between implementation of a coordinated care pathway in idiopathic scoliosis patients and a reduction in perioperative outcome disparities. Paediatr Anaesth. 2022 Apr;32(4):556-562. doi: 10.1111/pan.14330. Epub 2021 Dec 10.
PubMed 34758176Mesiti BL. Scoliosis: An Overview. Radiol Technol. 2021 Sep;93(1):55-72.
PubMed 34588279Janicki JA, Alman B. Scoliosis: Review of diagnosis and treatment. Paediatr Child Health. 2007 Nov;12(9):771-6. doi: 10.1093/pch/12.9.771.
PubMed 19030463Sun Y, Xing Y, Zhao Z, Meng X, Xu G, Hai Y. Comparison of manual versus automated measurement of Cobb angle in idiopathic scoliosis based on a deep learning keypoint detection technology. Eur Spine J. 2022 Aug;31(8):1969-1978. doi: 10.1007/s00586-021-07025-6. Epub 2021 Oct 30.
PubMed 34716822Ren J, Liu X, Chen F, Jing X, Cui X. Association Between Vertebral Rotatory Subluxation and the Apical Vertebra in Degenerative Lumbar Scoliosis. World Neurosurg. 2021 Oct;154:e627-e632. doi: 10.1016/j.wneu.2021.07.101. Epub 2021 Jul 28.
PubMed 34329750Liang JQ, Qiu GX, Shen JX, Lee CI, Wang YP, Zhang JG, Zhao H. A retrospective study of echocardiographic cardiac function and structure in adolescents with congenital scoliosis. Chin Med J (Engl). 2009 Apr 20;122(8):906-10.
PubMed 19493412Grunwald ATD, Roy S, Alves-Pinto A, Lampe R. Assessment of adolescent idiopathic scoliosis from body scanner image by finite element simulations. PLoS One. 2021 Feb 10;16(2):e0243736. doi: 10.1371/journal.pone.0243736. eCollection 2021.
PubMed 33566808Zhou Z, Liu F, Li R, Chen X. The effects of exercise therapy on adolescent idiopathic scoliosis: An overview of systematic reviews and meta-analyses. Complement Ther Med. 2021 May;58:102697. doi: 10.1016/j.ctim.2021.102697. Epub 2021 Feb 23.
PubMed 33636298Yan B, Lu X, Qiu Q, Nie G, Huang Y. Association Between Incorrect Posture and Adolescent Idiopathic Scoliosis Among Chinese Adolescents: Findings From a Large-Scale Population-Based Study. Front Pediatr. 2020 Sep 15;8:548. doi: 10.3389/fped.2020.00548. eCollection 2020.
PubMed 33042909Ko JY, Suh JH, Kim H, Ryu JS. Proposal of a new exercise protocol for idiopathic scoliosis: A preliminary study. Medicine (Baltimore). 2018 Dec;97(49):e13336. doi: 10.1097/MD.0000000000013336.
PubMed 30544395Makino T, Kaito T, Kashii M, Iwasaki M, Yoshikawa H. Low back pain and patient-reported QOL outcomes in patients with adolescent idiopathic scoliosis without corrective surgery. Springerplus. 2015 Aug 7;4:397. doi: 10.1186/s40064-015-1189-y. eCollection 2015.
PubMed 26261755Aulisa AG, Guzzanti V, Perisano C, Marzetti E, Specchia A, Galli M, Giordano M, Aulisa L. Determination of quality of life in adolescents with idiopathic scoliosis subjected to conservative treatment. Scoliosis. 2010 Sep 28;5:21. doi: 10.1186/1748-7161-5-21.
PubMed 20920196Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.
PubMed 27625122Radwan NL, Ibrahim MM, Mahmoud WS. Comparison of two periods of Schroth exercises for improving postural stability indices and Cobb angle in adolescent idiopathic scoliosis. J Back Musculoskelet Rehabil. 2022;35(3):573-582. doi: 10.3233/BMR-200342.
PubMed 34602457Beardsley C, Egerton T, Skinner B. Test-re-test reliability and inter-rater reliability of a digital pelvic inclinometer in young, healthy males and females. PeerJ. 2016 Mar 31;4:e1881. doi: 10.7717/peerj.1881. eCollection 2016.
PubMed 27069812
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stabilization Exercises Versus Schroth's Program on Posture and Quality of Life in Females With Idiopathic Scoliosis.
- ClinicalTrials.gov ID
- NCT05392504
- Acronym / sponsor ID
- REC/RCR & AHS/22/0519
- Conditions
- Scoliosis Idiopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 26 May 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.
The objective of this study is to compare the effects of core stabilization exercises versus schroth's program on posture and quality of life in females with idiopathic scoliosis
Detailed description
Scoliosis is a 3 dimension condition that effects most of our population specifically females. It is not only a bend in your spine but according to new research, its also twisting it. The curvature effects the effected individual physical and the social anxiety due to appearance and a continues state of lethargy effects their quality of life immensely. The posture is poorly effected along with a visual appearance. Often someone with scoliosis might find good posture difficult. Often someone with scoliosis will lean forwards and to the side either slightly or a lot. They will often try to avoid doing this, which can lead to slightly bent knees and the pelvis tilting backwards. Scoliosis is often defined as spinal curvature in the "coronal" (frontal) plane. While the degree of curvature is measured on the coronal plane, scoliosis is actually a more complex, three-dimensional problem which involves all 3 planes. It is defined by the Cobb's angle of spine curvature in the coronal plane and is often accompanied by vertebral rotation in the transverse plane and hypokyphosis in the sagittal plane. These abnormalities in the spine, costal-vertebral joints, and the rib cage produce a 'convex' and 'concave' hemithorax.
Only females having idiopathic scoliosis with cob's angle 10°-26° with age ranging between 19-30 are included and any subjects with surgical interventions are excluded.
Population will be divided in to two groups. One group will perform scroth exercises for 4 weeks and the other group will perform core straightening exercises for 4 weeks each. Once the time period is complete, the posture will be measured using pelvic and shoulder goniometers to check the level of tilt and for quality of lifestyle, we will be using quality of life (Scoliosis Research Society-22 questionnaire)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stability exercise | Experimental | Other: Core stability exerciseThe core stability training consist of three phases. The first and second phases each will last for three weeks in total, and the third phase will take place in four weeks. Each training session will begin with 10 minutes of warm-up exercises and finish with 10 minutes of cool-down exercises; both warm-up and cool-down exercises includes breathing and stretching exercises. The number of repetitions will be adjusted according to the participant's exercise tolerance. During the first week of each phase, the number of repetitions of each exercise will be 7-10, and this will progress to 10-15 based on the patient's physical tolerance. |
| Scroth's program | Active comparator | Other: Scroth's ProgramThe Schroth program include exercises for rotational breathing, spinal elongation, de-flexion, stretching, de-rotation, and strengthening, and these exercises are performed to improve the curvature, muscle strength, and endurance of postural muscles. During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support. The intensity of the Schroth exercises will gradually increased depending on the patient's improvement in exercise performance by decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Females only
- Positive Forward bend test (FBT)
- Idiopathic scoliosis
- Cob's angle 10°-26°
- Age group ranged between 19-30 yrs.
Key exclusion criteria (3 listed)
- Subjects with any surgical intervention for scoliosis
- Pregnant women
- Subjects with any serious health condition
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 |
|---|---|---|
| Core stability exerciseThe core stability training consist of three phases | Other | Core stability exercise |
| Scroth's ProgramThe Schroth program include exercises for rotational breathing, spinal elongation, deflexion, stretching, de-rotation, and strengthening | Other | Scroth's program |
Primary outcome
Scoliosis Research Society-22 questionnaire
Time frame: 4 week
It is a standardized questionnaire designed by scoliosis research society to measure the quality of life in scoliosis patients. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110.
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 17 Mar 2023.
- Background: PubMed 34758176Dela Merced P, Vazquez Colon C, Mirzada A, Oke A, Gal Z, Cheng J, Oetgen MM, Martin B, Pestieau SR, Cronin JA. Association between implementation of a coordinated care pathway in idiopathic scoliosis patients and a reduction in perioperative outcome disparities. Paediatr Anaesth. 2022 Apr;32(4):556-562. doi: 10.1111/pan.14330. Epub 2021 Dec 10.
- Background: PubMed 34588279Mesiti BL. Scoliosis: An Overview. Radiol Technol. 2021 Sep;93(1):55-72.
- Background: PubMed 19030463Janicki JA, Alman B. Scoliosis: Review of diagnosis and treatment. Paediatr Child Health. 2007 Nov;12(9):771-6. doi: 10.1093/pch/12.9.771.
- Background: PubMed 34716822Sun Y, Xing Y, Zhao Z, Meng X, Xu G, Hai Y. Comparison of manual versus automated measurement of Cobb angle in idiopathic scoliosis based on a deep learning keypoint detection technology. Eur Spine J. 2022 Aug;31(8):1969-1978. doi: 10.1007/s00586-021-07025-6. Epub 2021 Oct 30.
- Background: PubMed 34329750Ren J, Liu X, Chen F, Jing X, Cui X. Association Between Vertebral Rotatory Subluxation and the Apical Vertebra in Degenerative Lumbar Scoliosis. World Neurosurg. 2021 Oct;154:e627-e632. doi: 10.1016/j.wneu.2021.07.101. Epub 2021 Jul 28.
- Background: PubMed 19493412Liang JQ, Qiu GX, Shen JX, Lee CI, Wang YP, Zhang JG, Zhao H. A retrospective study of echocardiographic cardiac function and structure in adolescents with congenital scoliosis. Chin Med J (Engl). 2009 Apr 20;122(8):906-10.
- Background: PubMed 33566808Grunwald ATD, Roy S, Alves-Pinto A, Lampe R. Assessment of adolescent idiopathic scoliosis from body scanner image by finite element simulations. PLoS One. 2021 Feb 10;16(2):e0243736. doi: 10.1371/journal.pone.0243736. eCollection 2021.
- Background: PubMed 33636298Zhou Z, Liu F, Li R, Chen X. The effects of exercise therapy on adolescent idiopathic scoliosis: An overview of systematic reviews and meta-analyses. Complement Ther Med. 2021 May;58:102697. doi: 10.1016/j.ctim.2021.102697. Epub 2021 Feb 23.
- Background: PubMed 33042909Yan B, Lu X, Qiu Q, Nie G, Huang Y. Association Between Incorrect Posture and Adolescent Idiopathic Scoliosis Among Chinese Adolescents: Findings From a Large-Scale Population-Based Study. Front Pediatr. 2020 Sep 15;8:548. doi: 10.3389/fped.2020.00548. eCollection 2020.
- Background: PubMed 30544395Ko JY, Suh JH, Kim H, Ryu JS. Proposal of a new exercise protocol for idiopathic scoliosis: A preliminary study. Medicine (Baltimore). 2018 Dec;97(49):e13336. doi: 10.1097/MD.0000000000013336.
- Background: PubMed 26261755Makino T, Kaito T, Kashii M, Iwasaki M, Yoshikawa H. Low back pain and patient-reported QOL outcomes in patients with adolescent idiopathic scoliosis without corrective surgery. Springerplus. 2015 Aug 7;4:397. doi: 10.1186/s40064-015-1189-y. eCollection 2015.
- Background: PubMed 20920196Aulisa AG, Guzzanti V, Perisano C, Marzetti E, Specchia A, Galli M, Giordano M, Aulisa L. Determination of quality of life in adolescents with idiopathic scoliosis subjected to conservative treatment. Scoliosis. 2010 Sep 28;5:21. doi: 10.1186/1748-7161-5-21.
- Individual participant dataSharing planned: No
Related trials for Scoliosis Idiopathic
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
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.
Hafiza Mehjabeen, Ms principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability exercise and Scroth's Program in people with Scoliosis Idiopathic, run by Riphah International University at 2 sites in Pakistan.
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 8 inclusion and 3 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Scoliosis Research Society-22 questionnaire (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392504, which also lists 16 linked publications.
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 17 Mar 2023.