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.: PACTR202404715220300 Date of Approval: 09/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of High Intensity Focused Electromagnetic Therapy on Balance and Quality of Life in Elderly Diabetic Patients
Official scientific title Effect of High Intensity Focused Electromagnetic Therapy on Balance and Quality of Life in Elderly Diabetic Patients
Brief summary describing the background and objectives of the trial Elderly diabetic patients usually present with impaired balance increasing fall incidents which is a major health problem impacting their quality of life negatively (Alasmari et al., 2020). Core muscles, containing the abdominals, possess a pivotal role in maintaining and enhancing balance. Abdominal muscles strengthening which can effectively improve balance through improving the core muscles stability (Ikele et al., 2020). The high intensity focused electromagnetic therapy is a non-invasive treatment that can increase in the abdominal muscle thickness and strength (Kinney & Lozanova, 2018). So, this study will aims to evaluate the effect of high intensity focused electromagnetic therapy on balance and quality of life in elderly diabetic patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/04/2024
Actual trial start date 07/04/2024
Anticipated date of last follow up 06/07/2024
Actual Last follow-up date 08/07/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Balance training 30 minutes, 3 sessions / week 12 weeks Each session will start with a short (5-7 minute) warm-up (marching in place, one-leg standing, weight shifting, lunges, arm and neck movements), followed by exercises performed while sitting on balls (15 minutes) and exercises standing and walking (15-20 minutes). The sessions will end with short stretching and breathing exercises. The sitting, standing, and walking exercises differed among sessions to obtain variety, but every exercise returned later in the program, often in a more difficult form. 30 Active-Treatment of Control Group
Experimental Group High intensity focused electromagnetic therapy and balance exercises High-intensity focused electromagnetic therapy is 30 minutes, 2 times /week , in addition to a program of balance exercises for 30 minutes, 3 times /week 12 weeks. During the High-intensity focused electromagnetic therapy, patients will be lying in a supine position. All procedures were applied to the abdomen and each session included exactly 30 minutes of continuous application. One applicator will be placed on the skin at the umbilical level. The center of the magnetic coil will be placed exactly above the navel. The applicator will be affixed by a disinfected fixation belt to minimize movements during the procedure. The stimulation intensity start at 0% and within 60 seconds to the treatment it will be slowly increased by the operator until reaching patient's tolerance threshold. Balance training consists of (5-7 minute) warm-up (marching in place, one-leg standing, weight shifting, lunges, arm and neck movements), followed by exercises performed while sitting on balls (15 minutes) and exercises standing and walking (15-20 minutes). The sessions will endwith short stretching and breathing exercises. The sitting, standing, and walking exercises differed among sessions to obtain variety, but every exercise returned later in the program, often in a more difficult form. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Type 2 diabetes. 2- Walk independently. 3- Male only. 4- Age between 60 and 70. 5-BMI less than 30 Kg/m2. 1- Other types of diabetes. 2- Assistance walking aids. 3- Cerebellar disorders. 4- Metal implants. 5- Cardiovascular problems. 6-Musckloskeletal limitations. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 70 Year(s) Male
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 16/03/2024 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed Elzayat Cairo 8655 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Balance using Berg Balance Scale Before and after 12 weeks of the intervention
Secondary Outcome Quality of life using SF-12 survey Before and after 12 weeks of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Mahalla general hospital Bahr street El Mahalla Alkobra 31953 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Saher lotfy Abo ali Mahalla 12611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saher Elgayar Aboali Mahalla Aboali Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
saher lotfy abo ali mahala 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saher Elgayar saherlotfy020@gmail.com +201020429911 Gehad
City Postal code Country Position/Affiliation
Mahalla 31951 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Public Enquiries Mohamed Elhamrawy saher_lotfi@yahoo.com +201060667075 Bahrawy
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Gamil saherelgayar@yahoo.com 201022429914 Tagamoo
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Lecturer of Physical therapy for women health Faculty of Physical Therapy October University for Modern Sciences and Arts
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in carpal tunnel syndrome. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information