A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis

August 17, 2024 updated by: Khalid safwat elsayed, Cairo University

A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis: a Randomized Control Trial

This study aims to compare the effectiveness of mechanical traction and 3D apical vertebral mobilization and active exercises on Cobb's angle, spinal ROM, and function in patients with C-shaped scoliosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scoliosis is a skeletal issue causing asymmetries, leading to functional disruptions. Common symptoms include uneven eye tilt, drop asloped shoulder, and muscle imbalances. These changes can affect the patient's physical appearance and psychological state. Current treatments have shown suboptimal results due to the lack of accepted scientific theories for idiopathic scoliosis. Therefore, a new therapeutic approach is needed to provide novel insights and improve treatment outcomes. This underscores the need for a more comprehensive approach to scoliosis treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: khalid safwat elsayed, assistant lecturer
  • Phone Number: 01222397882
  • Email: Khalidd843@gmail.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • May University in Cairo (MUC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult individuals aged 18 to 30 years (after complete ossification and before the start of the ageing process and joint changes) as mentioned in studies.
  2. Thoracolumbar scoliosis with Cobb angle between 10 to 30 degrees because a curve below 10 degrees has no effect and above 30 is indicated for surgery.

Exclusion Criteria:

  1. History of orthopaedic surgeries.
  2. History of road traffic accidents (RTA).
  3. Myopathy.
  4. True leg length discrepancy.
  5. Neuropathy.
  6. Mental disorders.
  7. Bone tumor.
  8. Heart disease or circulatory problems.
  9. Early osteoporosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: traction with mobilization
it consists of 35 patients and patients will receive traction with mobilization 3 sessions per week for 3 months with a total of 36 sessions. there will be a follow-up for 2 months with home program exercises and postural instructions only followed by the same pre and post-treatment assessment measures
Other: traction and mobilization
The patient undergoes a 15-minute infrared therapy session, followed by flexibility and stretching exercises targeting the trunk and four extremities muscles. Land manipulation techniques are used for cervical, dorsal, and lumbar spine to assess and treat spinal dysfunctions. Deep breathing exercises with rib mobilization are also performed to promote respiratory function and thoracic flexibility. The session aims to improve overall health.
Active Comparator: active exercise therapy)
it consists of 35 patients and patients will active exercises 3 sessions per week for 3 months with a total of 36 sessions. there will be a follow-up for 2 months with home program exercises and postural instructions only followed by the same pre and post-treatment assessment measures
Other: active exercise therapy
Patients with adolescent idiopathic scoliosis will receive exercise programs from seven major schools under SOSORT, focusing on realigning the spine, rib cage, shoulders, and pelvis to normal anatomical postures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessment of degree of spinal curvature
Time Frame: at baseline and after 3 months
it will be assessed using the scoliometer which is typically consists of a level or inclinometer attached to a base. The scoliometer is placed along the spine, and the angle of deviation from the vertical is measured to assess the severity of the curvature
at baseline and after 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of the change of the weight, height and body mass index
Time Frame: at baseline and after 3 months
This scale (DT-150, Shanghai, China) Figure (3) will be used for the measurement of height and weight for each participant and the results will be used for the calculation of the Body Mass Index
at baseline and after 3 months
assessment of the change of the trunk flexion and extension ROM
Time Frame: at baseline and after 3 months
To measure flexion, the patient should bend forward at the waist comfortably without knees, and the examiner should stabilize the goniometer's stationary arm on the midline of the spine.
at baseline and after 3 months
assessment of the change of the trunk lateral flexion ROM
Time Frame: at baseline and after 3 months
To measure lateral flexion, the patient should lean comfortably sideways without bending forward or rotating the trunk, while the goniometer's stationary arm should be stabilized at the appropriate level.
at baseline and after 3 months
assessment of the change of the trunk rotation ROM
Time Frame: at baseline and after 3 months
To measure rotation, the patient rotates their trunk comfortably without moving their hips or feet. The goniometer is placed parallel to the ground, using the scapula's spine as a reference point. The stationary arm remains parallel to the starting position.
at baseline and after 3 months
assessment of the change of the cervical flexion and extension ROM
Time Frame: at baseline and after 3 months
To measure flexion, the patient should comfortably lower their chin towards their chest without bending their upper back or shoulders, maintaining straight-forward eyes.
at baseline and after 3 months
assessment of the change of the cervical lateral flexion ROM
Time Frame: at baseline and after 3 months
To measure lateral flexion, the patient should tilt their head sideways comfortably without rotating their head or shoulders, keeping their chin level during the movement.
at baseline and after 3 months
assessment of the change of the cervical rotation ROM
Time Frame: at baseline and after 3 months
To measure rotation, the patient should comfortably turn their head left or right without tilting their head or shoulders, maintaining straight eyes during the movement.
at baseline and after 3 months
assessment of the change of fingertips to floor distance
Time Frame: at baseline and after 3 months
The finger-to-floor distance test is a quick and convenient method to assess hamstring and lower back flexibility. It involves standing up straight, bending forward, lowering hands, reaching the endpoint, and measuring the distance between fingers and the floor.
at baseline and after 3 months
assessment of the change of the degree of spinal curvature
Time Frame: at baseline and after 3 months
To measure the Cobb angle on an X-ray, identify the vertebrae with the most tilted endplates, draw lines along the spine's curvature, draw perpendicular lines intersecting at a right angle, and measure the Cobb angle, which represents the degree of spinal curvature.
at baseline and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • khalid-005244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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