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.: PACTR202010720473779 Date of Registration: 12/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of the Effects of Neuromuscular Electrical Stimulation After Anterior Cruciate Ligament Reconstruction on Quadriceps muscle.
Official scientific title Assessment of the Effects of Neuromuscular Electrical Stimulation After Anterior Cruciate Ligament Reconstruction on Quadriceps muscle.
Brief summary describing the background and objectives of the trial Postoperative weakness, muscle atrophy, and impaired knee function are common following anterior cruciate ligament (ACL) reconstruction. During the first 4 weeks after surgery, significant quadriceps strength deficits, when compared to the contralateral limb, have been reported. Although knee stability is significantly improved Neuromuscular electrical stimulation NMES in addition to standard physical therapy appears to significantly improve quadriceps strength and physical function in the early post-operative period compared to standard physical therapy alone. Early strength prevent quadriceps muscle inhibition and atrophy, providing the rehabilitation subject with the most effective course of rehabilitation and return to sports The objective of this study is to assess the efficacy of NMES program applied after ACL reconstruction on the quadriceps muscle
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 09/10/2020
Actual trial start date
Anticipated date of last follow up 01/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FWA 000017585 FMASU REC
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group neuromuscular electrical stimulation 3 times a week lasting for 60 minutes Rehabilitation Program Following ACL Repair : Details of the content and progression of the basic rehabilitation program NMES Training Program: NMES will be delivered by means of Pagani apparatus (Master 932 ,Eeletronica , Italy) using four adhesive rubber electrode (6*4 cm) delivered biphasic symmetrical square pulses lasting up to 400 μs at a fequency of 50 Hz. The on-off ratio was 5:10 s and the ramp-up and ramp-down times lasted both 1 s. lasting for 60 minutes Current intensity was set until the occurrence of muscle contraction observed 20
Control Group regular rehabilitation program 3 times a week 30 minutes Rehabilitation Program Following ACL Repair : Details of the content and progression of the basic rehabilitation program 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals 18 years of age or older, who underwent ACL repair operation. . Subjects will be excluded from participation if they had undergone surgical repair of the meniscus or other knee ligaments concomitant with the ACL Repair. -also, will exclude patients that had initiated rehabilitation at another facility prior to their first physical therapy session at our facility. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 18/09/2020 Faculty of Medicine Ain Shams University REC
Ethics Committee Address
Street address City Postal code Country
Abasya square Cairo 11865 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement in quadriceps strength assessed by Quadriceps Strength: A maximum voluntary isometric torque test will be used to determine quadriceps strength. Testing will perform at 12 weeks and 16 weeks following the initial physical therapy treatment. Knee Outcome Survey—Activities of Daily Living Scale (ADLS).-Needle EMG assessment : It will be the objective way in measuring the effect of the two types of rehabilitation programs to assess which one is more effective. .3 months
Secondary Outcome return to sport activity 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Abasya Square Cairo 11865 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded fifth settlement cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self sponsered fifth settlement cairo 11865 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Hossam salaheldin Abdelmohsen Labib fifth settlement cairo 11865 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hala sabaah halams@med.asu.edu.eg 00201006720301 fifth settlement
City Postal code Country Position/Affiliation
cairo 11865 Egypt DR lecturer
Role Name Email Phone Street address
Public Enquiries hala sabaah halams@med.asu.edu.eg 00201006720301 fifth settlement
City Postal code Country Position/Affiliation
cairo 11865 Egypt DR Lecturer
Role Name Email Phone Street address
Scientific Enquiries hossam labib dr.sam789@yahoo.com 00201002058687 fifth settlement
City Postal code Country Position/Affiliation
cairo 11865 Egypt DR Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal Proposal should be directed to (halams@med.asu.edu.eg)To gain access
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