Efficacy of Postoperative Telerehabilitation in Adolescent Idiopathic Scoliosis

NCT05669859 | Completed DMC

• 1 other identifier: karanki1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, it is aimed to reveal the effects of Tele-Rehabilitation (TR) program, which is designed for the needs of individuals with Adolescent Idiopathic Scoliosis (AIS) who will undergo scoliosis surgery and will be carried out remotely, on pain, trunk endurance, spine flexibility, functional capacity, body appearance perception and quality of life. is intended. With this study, it is aimed to bring evidence-based data on the content of the online rehabilitation program, which can be remotely supervised in the post-surgical period, and the effectiveness and applicability of the applications to the literature. The study was carried out by Emsey Hospital - Advanced Spine Surgery Unit and Prof. Dr. It is planned with at least 34 individuals with AIS who were treated with Posterior Fusion and Instrumentation technique by an orthopedic specialist at Süleyman Yalçın City Hospital. In the randomized controlled design, experimental type planned study, individuals with a minimum of six months and a maximum of two years after surgery will be divided into two groups as the telerehabilitation group and the control group. Individuals in the telerehabilitation group will be included in the Telerehabilitation program, which is planned as two sessions a week, one to one and a half hours, for eight weeks, via remote online video conferencing method. The control group will not be included in any post-surgery rehabilitation program as it is routinely. In the study, pain intensity was determined with the "Numerical Rating Scale", body appearance perception with the "Scoliosis Appearance Questionnaire", quality of life with the "SRS-30 Scoliosis Patient Questionnaire", trunk muscle endurance with "position maintenance tests", flexibility of the spine with "Forward Reaching and Side Bending Tests", exercise capacity will be evaluated with the "Six Minute Walking Test". Evaluation of all cases included in the study was planned at two separate times with 8-week intervals. In the analysis of the data, continuous variables will be given as mean ± standard deviation, qualitative variables as number and percentage (%); statistical tests will be determined according to the distribution of the data, and the significance will be taken as p≤0.05 in all measurements.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

adolescent idiopathic scoliosis; telerehabilitation; scoliosis surgery

Outcome Measures

Primary Outcomes (6)

• Numeric Rating Scale

  With the Numeric Rating Scale (NRS), the person is asked to mark or say the number corresponding to the subjectively perceived pain intensity (0 = no pain - 10 = unbearable pain) on the scale, using an equally graded linear scale from 0 to 10.

  At the baseline and within one week of completion of the eight-week study period; Change in pain intensity at 8 weeks

• Biering Sorenson Test

  It is a valid test that evaluates trunk extensor muscle endurance. The length of time, in seconds, is recorded, when the patient is in the prone position, with the pelvic region and lower extremity in bed, without support.

  At the baseline and within one week of completion of the eight-week study period; Change in trunk extensor muscle endurance at 8 weeks

• Kraus Weber testi

  It is a valid test that evaluates trunk flexor muscle endurance. While the patient is on the treatment bed, with the hips and knees flexed to 90 degrees, the soles of the feet are fixed on the bed, the body is brought to 60 degrees of flexion and the time that he can stay in this position is recorded in seconds.

  At the baseline and within one week of completion of the eight-week study period; Change in trunk flexor muscle endurance at 8 weeks

• Lateral Bridge test

  It is a valid test used to evaluate anterior, posterior and lateral stabilizer general muscle endurance of the trunk. When the person is in the side-lying position, he is asked to carry his body on his forearms and toes, and the time he can maintain his position is recorded in seconds. Measurements are tested for both sides, right and left.

  At the baseline and within one week of completion of the eight-week study period; Change in anterior, posterior and lateral stabilizer general muscle endurance at 8 weeks

• Forward reach test

  In order to evaluate the flexibility of the thoracolumbar region in the sagittal plane, the patient is asked to lie in a long sitting position, without bending the knees, as far as the arms and feet can reach. The distance between the patient's third hand phalanx and the tips of the toes is measured with a tape measure and recorded in centimeters.

  At the baseline and within one week of completion of the eight-week study period; Change in flexibility of the thoracolumbar region in the sagittal plane at 8 weeks

• Side bending test:

  In this test, which is used to evaluate the flexibility of the spine, the patient is standing with his back against the wall, the feet are shoulder-width apart, the arms are on both sides, and the place where the third phalanx touches on the thigh is marked. Then, the patient is asked to bend as far as possible and the difference between the two marks is recorded in centimeters.

  At the baseline and within one week of completion of the eight-week study period; Change in flexibility of the spine at 8 weeks

Secondary Outcomes (4)

• Cobb method

  At the baseline and within one week of completion of the eight-week study period; Change in curve magnitude at 6 months.

• The Six Minute Walk Test

  At the baseline and within one week of completion of the eight-week study period; Change in functional capacity at 8 weeks

• Spinal Appearance Questionnaire (Tr-SAQ),

  At the baseline and within one week of completion of the eight-week study period; Change in appearance perceptions at 8 weeks

• Scoliosis Research Society Questionnaire- 30 (SRS-30)

  At the baseline and within one week of completion of the eight-week study period; Change in quality of life at 8 weeks

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

It consists of postoperative patients included in the rehabilitation program consisting of approximately one hour of exercise training to be conducted via remote online video-conference (WhatApp Messenger app) for eight weeks, with 2 sessions per week.

Procedure: Exercise

Control Group

NO INTERVENTION

It consists of patients who are called for control by the physician periodically for radiological evaluation and physical examination in the post-surgical period, and who are not included in any rehabilitation program as in routine post-surgical practice.

Interventions

Exercise PROCEDURE

The rehabilitation program designed in our study was based on the development of core muscle control and dynamic stabilization of the spine, which is generally required by patients. All exercises were combined with controlled breathing, focusing on the mobility of the extremities and the activity of multiple muscle groups. Our program created in this direction will start with face-to-face patient education; For 8 weeks, will be carried out remotely online under the supervision of a physiotherapist.On non-telerehabilitation days, they will be asked to keep an exercise diary, instructed to practice the exercise approach presented in sessions at home daily in 20-minute periods. The exercise diary will be checked during online sessions.

Telerehabilitation Group

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over 9 years old
• Being diagnosed with Adolescent Idiopathic Scoliosis,
• Having been operated with the Posterior Fusion and Instrumentation technique at least 6 months, at most 2 years ago
• Having a device that can be loaded with Internet technology (desktop, laptop, tablet or smartphone)
• Having skills and knowledge about online video communication

You may not qualify if:

• Individuals with AIS who have been operated with Anterior or Combined Antero-Posterior Spinal Fusion and Instrumentation, Thoracoscopic Vertebral Body Stretching techniques
• Previous spinal surgery
• Having advanced neuromuscular, rheumatological, orthopedic disease accompanying scoliosis,
• Presence of congenital deformity (short leg, limb agenesis or hypoplasia)
• Having a serious psychiatric or psychological disorder in a medical history,
• Subjected to a separate rehabilitation program accompanied by a physiotherapist,
• Those who are unable to do the evaluation and intervention methods to be applied in the research or who cannot cooperate.
• Individuals who are not suitable to use technological tools and do not have the necessary cognitive skills

Sponsors & Collaborators

• Halic University: lead
• Marmara University: collaborator

Study Sites (2)

Emsey Hospital

Istanbul, Turkey (Türkiye)

Location

Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• İrem Çetinkaya, MSc

  Haliç University

  PRINCIPAL INVESTIGATOR

• Tuğba Kuru Çolak, Phd

  Marmara University

  STUDY DIRECTOR

• Mehmet Fatih Korkmaz, Phd, MD

  İstanbul Medeniyet University

  STUDY CHAIR

• Mehmet Aydoğan, MD

  Emsey Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The exercise intervention planned in the study includes physical movements and is carried out by connecting to the participant via remote online communication tools.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: January 3, 2023
• Study Start: September 17, 2021
• Primary Completion: March 17, 2023
• Study Completion: June 17, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)