NCT05392504

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

May 23, 2022

Last Update Submit

March 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 week

Study Arms (2)

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.

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

Other: Scroth's Program

Interventions

The core stability training consist of three phases

Core stability exercise

The Schroth program include exercises for rotational breathing, spinal elongation, deflexion, stretching, de-rotation, and strengthening

Scroth's program

Eligibility Criteria

Age19 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with any surgical intervention for scoliosis
  • Pregnant women
  • Subjects with any serious health condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New canal medical center

Lahore, Punjab Province, 54000, Pakistan

Location

Pakistan Society for the Rehabilitation of the Disabled

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (16)

  • 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.

    PMID: 34758176BACKGROUND
  • Mesiti BL. Scoliosis: An Overview. Radiol Technol. 2021 Sep;93(1):55-72.

    PMID: 34588279BACKGROUND
  • Janicki 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.

    PMID: 19030463BACKGROUND
  • Sun 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.

    PMID: 34716822BACKGROUND
  • Ren 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.

    PMID: 34329750BACKGROUND
  • Liang 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.

    PMID: 19493412BACKGROUND
  • Grunwald 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.

    PMID: 33566808BACKGROUND
  • Zhou 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.

    PMID: 33636298BACKGROUND
  • Yan 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.

    PMID: 33042909BACKGROUND
  • Ko 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.

    PMID: 30544395BACKGROUND
  • Makino 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.

    PMID: 26261755BACKGROUND
  • Aulisa 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.

    PMID: 20920196BACKGROUND
  • Gur 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.

    PMID: 27625122BACKGROUND
  • Radwan 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.

    PMID: 34602457BACKGROUND
  • Beardsley 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.

    PMID: 27069812BACKGROUND
  • Korbel K, Kinel E, Janusz P, Kozinoga M, Czaprowski D, Kotwicki T. The measurement of health-related quality of life of patients with idiopathic scoliosis - comparison of ISYQOL versus SRS-22 questionnaire. Stud Health Technol Inform. 2021 Jun 28;280:323. doi: 10.3233/SHTI210529. No abstract available.

    PMID: 34190141BACKGROUND

Study Officials

  • Hafiza Mehjabeen, Ms

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

June 1, 2022

Primary Completion

September 15, 2022

Study Completion

September 22, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations