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.: PACTR201708002483416 Date of Approval: 29/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physiotherapy for flexor tendon injuries
Official scientific title Comparative Study between early active and early passive rehabilitation protocols following 2-strand flexor tendon repair
Brief summary describing the background and objectives of the trial Full active range of motion and prevention of flexion deformity in flexor tendon repair remains the main challenge facing hand surgeons worldwide. We made our study to compare early active mobilization protocol ¿place and hold¿ versus early passive mobilization ¿Modified Kleinert¿ after 2 strand modified Kessler repair. We reached that early active rehabilitation (place and hold) for two strand suture flexor tendon repair has a significant effect on contracture deformity, tendon lag, hand grip strength and adherent scares compared to the early passive program. So, early mobilization can be started after any type of repair not only four strand repairs with satisfactory results, and minimal side effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Flexor tendon injuries,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 31/07/2017
Actual trial start date
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status 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 random sequence generating website (http://www.randomizer.org) 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
Control Group Early passive rehabilitation (Modified Kleinert) 25 times per waking hours 6 weeks The digit is flexed by means of palmar and wrist bar to allow flexion of PIP and DIP joints then the patient tries to extend the finger actively against dorsal blocking splint 20
Experimental Group early active rehabilitation (Place and hold) 25 times per waking hours 6 weeks The digit is passively flexed by the unaffected hand then the patient tries to maintain the flexed posture through active contraction of the involved muscle for 5 seconds. Each patient was instructed to do these exercises 25 times per waking hours. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ All flexor tendon injuries in all zones of the hand ¿ Male and female patients between the age of 15 to 75 years ¿ Patients less than fifteen years old because of higher incidence of tendon rupture. ¿ Patients who are above seventy- five were also excluded as they have been shown to have deterioration of hand function scores, and normative data for these patients are not available ¿ Patients with crushing injury with extensive soft-tissue loss, documented compliance problems (e.g., substance abuse). ¿ Medical conditions preventing repair, preexisting problems such as arthritis limiting joint motion were also excluded. 15 Year(s) 75 Year(s) Both
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
No 30/07/2017 Scientific Research Ethical Committee at Faculty of Medicine, AIn Shams University
Ethics Committee Address
Street address City Postal code Country
56 Ramsis St., Abbasseya, Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rupture rate 6 weeks
Primary Outcome Flexion deformity of DIP and PIP 6 weeks
Primary Outcome Flexor tendon lag 6 weeks
Secondary Outcome Disability by validated Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire 6 months
Secondary Outcome Patients satisfaction with their hand function on an analog scale from 1 (completely dissatisfied) to 10 (completely satisfied) 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Plastic Surgery Department, Faculty of Medicine, Ain Shams University 56 Ramsis St., Abbasseya, Cairo Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No Funding Source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals 56 Ramsis St., Abbasseya, Cairo 11566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hala Mohammed Abdel Sabour 56 Ramsis St., Abbasseya, Cairo 11566 Egypt
Mohey Eldin Ragab Elbanna 56 Ramsis St., Abbasseya Cairo 11566 Egypt
Ahmed Mohammed Abel Sallam 56 Ramsis St., Abbasseya, Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir Labib amirlabib2001@gmail.com 00201001720182 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Ass. Lecturer in Plastic Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Role Name Email Phone Street address
Public Enquiries Amir Labib amirlabib2001@gmail.com 00201001720182 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Ass. Lecturer in Plastic Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdel Sallam Ahmed_abdel_salam99@yahoo.com 00201009468825 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer in Plastic Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt
REPORTING
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