Implementation of Specific Tailored Exercises Program Versus Exergaming Exercises on Cobb Angle in the Treatment of Adolescent Idiopathic Scoliosis. (IS)
Implementation of Specific Tailored Exercises Program Versus Exergaming Exercises on Cobb Angle in the Treatment of Adolescent Idiopathic Scoliosis: a Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Randa Amin, phd
- Phone Number: 01013939174
- Email: Randaamin1311@hotmail.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Thoracic spine region with C-shaped scoliosis
- Individuals aged 10-18 years
- Cobb's angle from 10 to 25 degrees
- Both genders (male and female)
- Adolescent idiopathic scoliosis
Exclusion Criteria:
- Mental health disorders
- Neuromuscular or rheumatic diseases
- A history of spinal surgery
- Patients been prescribed brace treatment
- Leg length discrepancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Specific Tailored Exercises Program
eighteen patients will receive Specific Tailored Exercises Program plus traditional physical therapy three times per week for three months
|
the patients will receive a specific tailored exercise program in the form of corrective exercises, positioning, mirror therapy, ADL adaptation, and instructions in addition to traditional physical therapy treatment.
the patients will receive traditional treatment only of the intervention in the form of stretching, strengthening, core stabilization and breathing exercises
|
|
Experimental: Exergaming Exercises
eighteen patients will receive Exergaming Exercises plus traditional physical therapy three times per week for three months
|
the patients will receive traditional treatment only of the intervention in the form of stretching, strengthening, core stabilization and breathing exercises
Every participant in group B will be received an exergaming exercises in form of a series of Kinect training game, sports island freedom game .
dance evolution game and Kinect sports games designed for Xbox 360 Kinect console.
The games will be projected onto a 24-Inch screen monitor.
Each session consisted of playing 1-2 trials in a row of each game for 45-60 minutes in addition to traditional physical therapy
|
|
Active Comparator: traditional physical therapy
eighteen patients will receive traditional physical therapy three times per week for three months
|
the patients will receive traditional treatment only of the intervention in the form of stretching, strengthening, core stabilization and breathing exercises
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cobb's angle
Time Frame: up to three months
|
cobbs angle will be measured by x-ray.
This method quantifies the lateral spinal curvature measured on a radiograph in the coronal plane, using anterior-posterior (AP) or posterior-anterior (PA) radiographs.A Cobb angle in the range of 10 to 20 degrees is considered as mild scoliosis.
Scoliosis severity is moderate when the Cobb angle ranges from 20 to 40 degrees.
|
up to three months
|
|
the angle of trunk rotation
Time Frame: up to three months
|
Scoliometer mobile applications is a valid and reliable method used to assess the angle of trunk rotation.
It is a portable, accessible and easy tracking and follow up.
Visual interface and digital readout.
Save and track angle trunk rotation values over time
|
up to three months
|
|
flow rate of inhalation
Time Frame: up to three months
|
The flow rate of inhalation in respiratory physiology refers to the rate at which air moves into the lungs during inspiration, i.e., The volume of air that enters the lungs per unit of time during inspiration.
(e.g., mL/sec ).
In a flow-based incentive spirometer, this flow rate is indicated by rising elements (e.g., balls) in the device that reflect how quickly air is drawn in during inspiration.
For proper medication delivery from a Dry Powder Inhaler (DPI), a flow rate of inhalation of greater than 60 L/min is generally considered optimal.
|
up to three months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
life disability
Time Frame: up to three months
|
It will be measured by the Arabic version of the Scoliosis Research Society -22 Questionnaire (SRS-22).
The scale consists of 22 questions and 5 subdimensions, namely, pain, self-image, spinal functions, mental health, and treatment satisfaction.
All of these sections are evaluated separately or by summing all questions under a total result score.
Scores were calculated by assigning a value between 1 and 5 for each question.
Accordingly, the lowest total score of the survey was 1, and the highest total score was 5, with higher scores indicating better QoL.
|
up to three months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- P.T.REC/012/006202
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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