- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07260383
Telerehabilitation Support for Home Exercise in Mild AIS
Enhancing Home-Based Exercise Therapy With Telerehabilitation in Mild Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity character-ized by a curvature of the spine greater than 10 degrees in the coronal plane, a deteri-oration in the physiological curvature in the sagittal plane and accompanying rotation in the axial plane. AIS is mostly seen at the thoracic level, less frequently at the lumbar and thoracolumbar levels, and is the most common form of structural scoliosis, accounting for approximately 80% of all scoliosis cases .
In AIS, the problem with spinal alignment affects the bones and soft tissue in the entire body; the resulting deformities such as postural disorders and loss of flexibility of the spine cause problems such as cosmetic concerns, functional losses, and pain in adolescents. In severe cases, respiratory functions and lung capacity decrease, and the patient's quality of life is affected by this condition. Different treatment approaches are recommended for the prevention and management of all these problems. When determining the appro-priate treatment option, the type, shape, degree of the curve, and the patient's charac-teristics should be taken into consideration. To stop or prevent the progression of the curve or to combat the complications experienced; different exercise approaches for scoliosis, the use of corsets, and, in more severe cases, surgical methods are the basic/ main treatment options. In addition, the incidence of curves of 10° and above varies between 1 and 3%, and most of them do not require surgical intervention. For moderate curves below 40°, special exercises and corsets are expressed as first-line treatments to control scoliosis without the need for surgery, therefore various exercise approaches are frequently used at all stages of AIS treatment.
When the literature is examined, it has been reported that exercises for AIS are often recommended to prevent the progression of the curve, correct postural behavior and provide awareness, increase neuromotor control of the spine, increase spinal and thoracic flexibility, increase muscle strength by optimizing muscle balance, and achieve body symmetry. In the treatment of scoliosis, specific exercises are usually given to the individual according to the shape, type, and degree of the curve. Therapeutic exercises include breathing exercises, self-correction exercises (mental imagery, exteroceptive, proprioceptive stimuli, and mirror control), and stabilization exercises (physical exercise, yoga, pilates, and core stabilization).
Telerehabilitation-based interventions are preferred to continue treatment when patients' access to rehabilitation needs is restricted for various reasons. Telerehabilitation has been applied to various diseases and has achieved significant success these days, but telerehabilitation studies in AIS patients are quite rare. Studies in this field have increased their popularity with the rise of telerehabilitation after the pandemic period and have begun to show promising results.
There are limited studies comparing telerehabilitation with home exercises; however, recent studies have shown that telerehabilitation may provide more positive results in terms of respiratory function, flexibility and participation . These findings reveal that telerehabilitation may positively affect exercise compliance and clinical out-comes in AIS; however, due to the small number of studies and the variety of exercises applied in the studies, the number of comparative data regarding the application of ex-ercises for scoliosis via telerehabilitation remains quite limited. In addition, the difference between the results obtained when the home programs are completely applied by oneself and the results obtained when a physiotherapist guides them remotely via telerehabil-itation has not been fully established. In this context, the aim of the study is to examine the effectiveness of the home-based exercise program, which is recommended as a standard after diagnosis in the hospital, in individuals diagnosed with adolescent idiopathic sco-liosis (AIS) and supported by a physiotherapist via telerehabilitation, compared to the same exercise program being applied individually at home. Our study is one of the few that directly examines the effect of supervision on clinical outcomes and has a unique place in terms of comparative evaluation of telerehabilitation with home programs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye), 34668
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The inclusion criteria for the study were "being between 10 and 18 years old, di-agnosed with adolescent idiopathic scoliosis (AIS) and not using a corset, having a Risser stage between 0 and 3 and a Cobb angle between 10° and 25°, individuals with a Type I curve pattern according to the Lenke classification."
Exclusion Criteria:
The exclusion criteria were determined as "those with any medical contraindication that may prevent them from doing exercise, patients who have undergone any treatment for scoliosis within the last year, patients who have undergone spinal surgery and patients using a corset, and patients with any mental, neurological and pulmonary disease."
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Telerehabilitation
|
Patient specific exercises with supervised telerehabilitation.
Participants included in the study program group also had the same home exercise program given in the hospital.
The exercises were same with the other group.
In addition to these home exercises, the exercises were done online under the guidance of a physiotherapist once a week.
An appointment was made for the first telerehabilitation session for the patients in the study group after the evaluation and the same exercise form was shared with this group.
In the online sessions, whether the patient correctly applied the exercise program defined for him/her was monitored and checked online once a week
|
|
Active Comparator: Home-based Exercise
|
Self Scoliosis exercises.
home exercises were shown to the control group and a form containing explanations and pictures of the exercises was shared with the patient in printed form.
They are very common well known posture exercises including postural correction, strengthening and core stabilization.
Participants were asked to apply the exercises at least three times a week and to record the day and duration of each exercise session in.
an exercise diary.
The researcher physiotherapist called these participants every two weeks to follow their compliance with the exercise program.
At the end of the eight-week application period, the participants were invited back to the clinic and re-evaluated with the same evaluation methods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Newyork posture scale
Time Frame: baseline and week 8
|
baseline and week 8
|
|
Walter Reed Visual Assessment Scale
Time Frame: Baseline and week 8
|
Baseline and week 8
|
|
cobb angle
Time Frame: baseline
|
baseline
|
|
visual analog scale
Time Frame: baseline and week 8
|
baseline and week 8
|
|
Scoliosis Research Society -22 (srs 22)
Time Frame: baseline and week 8
|
baseline and week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Spinal Diseases
- Spinal Curvatures
- Behavior
- Scoliosis
- Motor Activity
- Health Services Administration
- Delivery of Health Care
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Telemedicine
- Patient Care Management
- Telerehabilitation
Other Study ID Numbers
- ZDT--2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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