HKUCTR

HKU CLINICAL TRIALS REGISTRY
 

Study Registration and Background Information
Study Identifier: HKUCTR-2226
Date of Study Registration: 22 Jun 2017
Official Scientific Title of Study: Efficacy in Scoliosis Specific Exercises (SSE) in patients with adolescent idiopathic scoliosis (AIS) during bracing: A preliminary study
Brief Title of Study (if applicable): Efficacy in SSE in patients with AIS during bracing: A preliminary study
Protocol No.: UW17-136
Research Ethics Approval/ Ref. No.: Yes / UW17-136
Regulatory Approval/ Ref. No. (if applicable): N/A
Anticipated Study Start Date: 01 May 2017
Study Status: Completed / Terminated
Study Type, Design and Methodology
Study Type:
Non-interventional
Retrospective and Cohort study (comparing different cohorts)
Study Design:
Methods of Assignment:
N/A
Degree of Masking
Group Assignment
Phase of Study
N/A
N/A
N/A
Disease Area: Musculoskeletal system and connective tissue
Medical Condition: Adolescent Idiopathic Scoliosis
Intervention: N/A
Control: N/A
Primary Outcome: Primary outcome
• The primary endpoint is the difference in the Cobb angle between pre- and post -treatment. A 5° change of Cobb angle is considered significant according to the SRS criteria.
Secondary Outcome: Secondary outcome
• Changes in truncal shift
• Changes in angle of trunk rotation (ATR).
• Differences in SRS-22 questionnaire scores.
Inclusion Criteria: Patients are included under the following inclusion criteria:
• Diagnosed with AIS and meet the indications for bracing between 2011 and 2015
• Age 10 to 15 years
• Cobb angle of 25-50°,
• No prior received treatment,
• Patients prescribed the Schroth exercise therapy by DKCH physiotherapists (case group only)
Exclusion Criteria: Exclusion criteria
Patients are excluded under the following exclusion criteria:
• An underlying cause or association that may cause scoliosis,
• Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis
Target Sample Size:
No. of subjects to be recruited at local site:
48
Sites of Recruitment: Orthopardics & Traumatology
The Duchess of Kent Children's Hospital at Sandy Bay, 12 Sandy Bay Road, Pokfulam, Hong Kong
Physiotherapy
The Duchess of Kent Children's Hospital at Sandy Bay, 12 Sandy Bay Road, Pokfulam, Hong Kong
Contact Information
Principal Investigator:
Name:
Dr. Kenny Kwan
Department/Unit:
Department of Orthopaedics & Traumatology
Tel:
2255 4654
General Enquiries:
Name:
HKUCTR Administrator
Address:
Clinical Trials Centre, 6/F, Block T, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong
Tel:
2255 2548
Sponsor & Funding Support
Primary Sponsor: Dr Kenny Kwan, Department of Orthopaedics & Traumatology, University of Hong Kong
Sources of Funding:
Type
Supporting Organization
Commercial
N/A
Non-commercial
N/A