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.: PACTR202010887172053 Date of Approval: 09/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title the effect of the Neuromuscular Electrical Stimulation effect on contralateral Quadriceps muscle
Official scientific title Assessment of Neuromuscular Electrical Stimulation effect on contralateral Quadriceps muscle
Brief summary describing the background and objectives of the trial Neuromuscular electrical stimulation (NMES), a popular rehabilitative modality, induces contraction of neuromuscular system by applying electrical current. In the field of rehabilitation, The acute application of NMES induces a peripheral muscle contraction while also involving the central nervous system as shown by transient increases in spinal motor neuron and cortical activity. Furthermore, several studies have reported that NMES facilitates healing of the corticospinal tract (CST) directly . The aim of this study is to assess the effect of high frequency NMES on contralateral quadriceps muscle in normal individuals using needle EMG
Type of trial CCT
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 10/10/2020
Actual trial start date
Anticipated date of last follow up 10/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FWA 000017585 FMASU Ethical committee
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group neuromuscular electrical stimulation NMES for the quadriceps muscle on one side a single session of approximately 90 min of NMES a single session of approximately 90 min 1-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 will be set with the occurrence of muscle contraction 2-Assessment of EMG activity The EMG activity of VL and rectus femoris (RF) muscles on the other contralateral side (left side) will be recorded using needle EMG (Deymed Diagnostic,True Trace EMG, Czech) , disposable concentric needles will be used for assessment of minimal volition for about 20 MUAPs and maximal volition or interference pattern analysis which will be at 1mv/d and 200ms/d 20
Control Group electromyography twice before start session and at the end 15 minute Assessment of EMG activity The EMG activity of VL and rectus femoris (RF) muscles on the other contralateral side (left side) will be recorded using needle EMG (Deymed Diagnostic,True Trace EMG, Czech) , disposable concentric needles will be used for assessment of minimal volition for about 20 MUAPs and maximal volition or interference pattern analysis which will be at 1mv/d and 200ms/d ,and the electromyographic software will calculate the turns/second (T) (Hz), amplitude/turn (M) (uV) and M/T ratio (%) automatically this assessment will be done twice the first was before the start of NMES and the second time will be at the end of the program. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
participates included in the study will be adult normal male individuals free of any chronic medical illness. Age range from 20 to 45 years old. No previous experience with NMES. - Participants younger than 18 years old - Participants who have any cardiovascular, musculoskeletal, and neurological disorders Adult: 19 Year-44 Year 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 28/09/2020 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Abasyia square cairo 11865 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of EMG activity The EMG activity of VL and rectus femoris (RF) muscles on the other contralateral side (left side) will be recorded using needle EMG this assessment will be done twice the first was before the start of NMES and the second time will be at the end of the program..to assess the improvement on the contralateral quadriceps muscle power. to search for faciliatory effect occurred by NMES after the end of NMES session
Secondary Outcome strengthen for the quadriceps muscle on one side can be done by stimulation to the other side which can be applied later to all patients after end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospital Abasyia squre cairo 11865 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no source 20 fifth settlement cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor researchers fifth settlement cairo 11865 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
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 00201008889638 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 our study is trying to search for the best rehabilitation method after ACL reconstructive surgery. we are assessing either usual rehabilitation program or this program in addition to neuromuscular electric simulation sessions. the assessment will be by help of questionnaire and EMG test for the quadriceps muscle to have objective results. so, the second program will be mostly the effective one Study Protocol 2 months PDF
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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