Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003213442 Date of Approval: 18/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Whole body vibration and gait
Official scientific title Effect of whole body vibration on gait parameters in postmenopausal women with low bone mineral density
Brief summary describing the background and objectives of the trial Osteoporosis is major public health problem that becomes increasingly prevalent worldwide. It is a skeletal disorder that is characterized by comprised bone strength. Decreases in bone mineral density (BMD), muscle mass, strength and power causes gait and balance problems, increases fall risk and leads to function independence. It has been reported that lower gait speed, reduced step length timed one leg stance and lower ground reaction force is associated with lower BMD. It was reported that there was a significant decrease in dynamic hip range of motion and hip extensor moments in elderly subjects with low BMD. The failure of the locomotion and the outcomes of falls are determined by the applied forces and bone strength. So focusing on bone alone in the treatment of osteoporosis addresses only one part of the problem and the treatment should also focus in the muscles. The clinical consequences and economic burden of this disease call for measures to allow for appropriate intervention. Whole body vibration (WBV) is a neuromuscular training method that has an effect on bone strength and muscle strength. To the authors knowledge, there is no study that investigates the effect of whole body vibration on gait parameters in postmenopausal women with low bone mineral density.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,osteoponia/osteoporosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 10/04/2007
Actual trial start date 03/06/2007
Anticipated date of last follow up 10/04/2009
Actual Last follow-up date 01/01/2009
Anticipated target sample size (number of participants) 28
Actual target sample size (number of participants) 28
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised computer software program sealed opaque envelops Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group whole body vibration 3 sessions per week 24 weeks Medical treatment and sessions of Whole body vibration training. Participants stood on a vibrating platform in various position: half-squat, wide stance squat, squat, deep squat, one-legged squat, one legged stance and lunge with gradual increasing duration and intensity 14
Control Group Medical treatment Calcium (1200mg) and vitamin D (800IU) once daily 24 weeks Calcium (1200mg) and vitamin D (800IU) once daily 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
28 postmenopausal women with low BMD (T-score<-1). Their age will be 50-60 years. Their body mass index <25 and <30kg/m2. They experience menopause for 3 years or more. Spondylolisthesis diabetes neuromuscular diseases renal diseases thrombosis leg deformities previous surgeries at back/lower limbs. 50 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/04/2007 Institution Review Board (Faculty Council), Faculty of Physical Therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
& Ahmed ElZayat street Dokki; Giza 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gait parameters at starting and after 24 weeks of treatment course
Primary Outcome Bone mineral density at L2-4 and femur at starting and after 24 weeks of treatment course
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nasser Institute Hospital for Research and Therapy 1351 Corniche Al Nile, Aghakhan, Shoubra Misr Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No source of funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abeer ElDeeb 7 Ahmed ElZayat st., Been Elsarayat Dokki, Giza 12622 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Salwa ElBadry 7 Ahmed ElZayat st., Been Elsarayat Dokki, Giza 12622 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer ElDeeb beroeldeeb@yahoo.com 0201001811588 7 Ahmed ElZayat street,Been ElSarayat
City Postal code Country Position/Affiliation
Dokki, Giza 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Abeer ElDeeb beroeldeeb@yahoo.com 0201001811588 7 ahmed ElZayat street,Been ElSarayat
City Postal code Country Position/Affiliation
Dokki, Giza 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Abeer ElDeeb beroeldeeb@yahoo.com 0201001811588 7 ahmed ElZayat street,Been ElSarayat
City Postal code Country Position/Affiliation
Dokki, Giza 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
REPORTING
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