A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
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
July 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 17, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedAugust 20, 2024
August 1, 2024
6 months
August 17, 2024
August 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of degree of spinal curvature
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 Outcomes (9)
assessment of the change of the weight, height and body mass index
at baseline and after 3 months
assessment of the change of the trunk flexion and extension ROM
at baseline and after 3 months
assessment of the change of the trunk lateral flexion ROM
at baseline and after 3 months
assessment of the change of the trunk rotation ROM
at baseline and after 3 months
assessment of the change of the cervical flexion and extension ROM
at baseline and after 3 months
- +4 more secondary outcomes
Study Arms (2)
traction with mobilization
EXPERIMENTALit 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
active exercise therapy)
ACTIVE COMPARATORit 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- History of orthopaedic surgeries.
- History of road traffic accidents (RTA).
- Myopathy.
- True leg length discrepancy.
- Neuropathy.
- Mental disorders.
- Bone tumor.
- Heart disease or circulatory problems.
- Early osteoporosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
May University in Cairo (MUC)
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 17, 2024
First Posted
August 20, 2024
Study Start
July 1, 2024
Primary Completion
January 1, 2025
Study Completion
May 1, 2025
Last Updated
August 20, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share