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.: PACTR202309863893315 Date of Approval: 28/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The outcome measures of pneumatic compression versus high-frequency vibration on quality of life in diabetic polyneuropathy patients
Official scientific title The outcome measures of pneumatic compression versus high-frequency vibration on quality of life in diabetic polyneuropathy patients
Brief summary describing the background and objectives of the trial neuropathy is nerve injury that starts with the longest nerves that innervate the toes and progresses proximally. Common symptoms are numbness, tingling, pain and/or weakness starting in the distal lower extremities. According to the International Diabetes Federation, 382 million people worldwide are currently affected by diabetes, one of the leading causes of neuropathy. The distal symmetrical polyneuropathy (DSPN) is the commonest clinical form of diabetic neuropathy, affecting more than 90% of the patients. Generally, DSPN affects the toes and distal foot, but slowly progresses proximally to involve the feet and legs in a stocking distribution. The purpose of the study is to compare the effect of pneumatic compression and high-intensity vibration on quality of life in diabetic polyneuropathy patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 28/09/2023
Actual Last follow-up date 01/10/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group high frequency vibrator 12 sessions per week 7 mins A local vibration with a frequency of 62.5 Hz for 7 min was applied to the plantar side of both feet& cuff muscle and dorsal aspect of the foot The device was placed on a footstool, out of bed. The patient was treated for three sessions every other week. 20
Experimental Group pneumatic compression for both lower limbs for diabetic polyneuropathy Every session lasted 15 min for 3 times / week 3 time / week for 12 weeks. The intervention was conducted by using IPC for all sessions with 1-day interval. Every session lasted 15 min with pressure of 170 mmHg. 20
Control Group conventional program for both lower limbs with program for diabetic polyneuropathy 12 weeks (3 sessions/ week). 12 weeks (3 sessions/ week). Conventional exercise consist of: - Infra Red Thermal Stimulation on the lower limb for 10 mins repeated 3time/week for 12 weeks. - Stretching exercises for calves and hamstrings: Subject sit on a chair or bench and take chin down towards one shoulder then use hand on top of head to encourage chin down, while using other hand to grab the chair behind subject and resist. -Balance exercises each subject will use balance board for 5 mins three times a week for three months (12 sessions) to improve balance ability and to prevent falls. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Sixty female patients. 2- Their ages will range from 50 to 60 years old. 3- Their HbA1c is more than 7% and less than 9 %. 4- Bilateral lower limb chronic DPN. 5- They suffer mild diabetic polyneuropathy for at least three months. 6- All the patients have significant decrease in the sensory (sural &superficial peroneal) lower limb nerve conduction velocity (from 20 m/s to 30 m/s). 7- All the patients have significant decrease in the motor (tibial &deep peroneal) lower limb nerve conduction velocity (from 20 m/s to 30 m/s). 8- All the patients have score more than in 20 Norfolk QOL-DN. 9- They all have score more than 8 on Toronto scoring system. 10- They have willingness to participate in this study. 1. Chest diseases (either obstructive or restrictive). 2. Smoker patient. 3. Clinical signs of a severe cardiac event. (eg, congestive heart failure), 4. Severe psychiatric or cognitive impairment, who unable to follow comment. 5. Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge). 6. Other type of polyneuropathy (Alcoholic, hereditary…..). a) Any patient that suffer from lower limb pathology that may interfere with the results like: b) Cellulitis. c) Lower limb pressure or diabetic ulcer. d) Atherosclerosis. e) Deep venous thrombosis. Middle Aged: 45 Year(s)-64 Year(s) 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 11/12/2022 research ethical committee faculty of physical threrapy cairo university
Ethics Committee Address
Street address City Postal code Country
1 Gamaa Street, Giza, Egypt cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome sensory and motor nerve conduction velocity 3 months
Secondary Outcome The Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN): 3months
Secondary Outcome Toronto clinical scoring system (TCSS) 3 months
Secondary Outcome The Berg Balance Scale (BBS 3 months
Secondary Outcome brief painful inventory scale for diabetic peripheral neuropathy 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kafr el sheikh general hospital al awkaf street kafr el sheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed shawky el iraqi omar ibn el kataab street kafr el sheikh 33511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor kafr el sheikh general hospital seedy qotb -kafr el sheikh kafr el sheikh 33511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
prof dr .hany ezat obaya ahmed el zayat street cairo 11511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hany ezat hany_ezat@yahoo.com 01010242518 ahmed el zayat street
City Postal code Country Position/Affiliation
cairo 11511 Egypt assistant professor cairo university
Role Name Email Phone Street address
Public Enquiries hend abdelmoneam drhendpt@cu.edu.eg 01115507195 el tahrir street
City Postal code Country Position/Affiliation
cairo 11511 Egypt assistant professor cairo university
Role Name Email Phone Street address
Scientific Enquiries hussein abo saleh info@rouhegy.com 0473162838 el darayeb streer
City Postal code Country Position/Affiliation
kafr el sheikh 33511 Egypt kafr el sheikh university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: “Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. 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. Time Frame: “Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” Access Criteria: ““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). For more information or to submit a request, please contact clinicalresearchsupportcenter@ucdenver.edu.” Clinical Study Report 12 months 1-univeristy professors 2-medical doctors 3-clinical researches
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/07/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/07/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information