NCT04215497

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 18, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

December 25, 2019

Last Update Submit

January 15, 2020

Conditions

Scoliosis; AdolescenceSpinal CurvaturesProprioceptionPhysiotherapyExercise

Keywords

scoliosisPSSEproprioceptionjoint reposition

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 week

Secondary Outcomes (7)

  • Spinal pain assessment

    8 week

  • Frontal-sagittal plan posture evaluation

    8 week

  • Body Symmetry

    8 week

  • Body Symmetry

    8 week

  • Deformity perception assessment

    8 week

  • +2 more secondary outcomes

Study Arms (2)

Physiotherapeutic Scoliosis-Specific Exercises

EXPERIMENTAL

PSSE group will receive corrective exercise for scoliosis

Other: PSSE

Control

NO INTERVENTION

Control group will be taken to the queue list.

Interventions

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.

Physiotherapeutic Scoliosis-Specific Exercises

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa, Faculty of Health Science

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisSpinal CurvaturesMotor Activity

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 25, 2019

First Posted

January 2, 2020

Study Start

October 1, 2018

Primary Completion

August 25, 2019

Study Completion

September 1, 2019

Last Updated

January 18, 2020

Record last verified: 2019-12

Locations

TU(1)