- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02869373
Spinal Stabilization Exercise Effects in Hypermobility
August 12, 2016 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
Assistant Professor
The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
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
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- volunteers in an age range of 18 to 30,
- being women,
- having benign joint hypermobility syndrome diagnosed according to the Brighton criteria,
- having no contraindication to join an exercise program.
Exclusion Criteria:
- having rheumatologic or neurologic diseases,
- any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains,
- associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta,
- severe psychological disorders,
- being pregnant,
- intervention including exercise or physical therapy in the last 3 months.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Exercise
spinal stabilization exercise program was applied
|
In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in musculoskeletal pain intensity as measured by Visual Analog Scale
Time Frame: Change from baseline musculoskeletal pain intensity at 8 weeks
|
Change from baseline musculoskeletal pain intensity at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests
Time Frame: Change from baseline trunk muscle endurance at 8 weeks
|
Change from baseline trunk muscle endurance at 8 weeks
|
Change in postural stability as measured with Biodex Balance System SD
Time Frame: Change from baseline postural stability at 8 weeks
|
Change from baseline postural stability at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Seyda TOPRAK CELENAY, Yildirim Beyazit University
- Principal Investigator: Derya Ozer Kaya, Izmir Katip Celebi 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
April 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
August 12, 2016
First Submitted That Met QC Criteria
August 12, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Estimate)
August 16, 2016
Last Update Submitted That Met QC Criteria
August 12, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2015-64/82
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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