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.: PACTR201707002429342 Date of Approval: 14/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title goal based versus time based ACL rehabilitation protocol
Official scientific title goal based versus time based rehabilitation protocol after anterior cruciate ligament reconstruction : a randomized blinded clinical trial
Brief summary describing the background and objectives of the trial The prevalence of knee injuries is approximately 48/1000 patients a year, 9% of which are ligamentous injuries with anterior cruciate ligament (ACL) being the most common of these. The ACL is one of the four major ligaments that minimize stress on the knee joint and ensures joint stability through resistance against motion caused by anterior tibial translation and internal tibial rotation. ACL injury leads to disuse atrophy of the thigh muscles, destabilizes the knee joint, reduces control of nerve roots, decreases joint active range of motion. Current programs emphasize full passive knee extension, immediate weight bearing as tolerated, and functional exercises Accelerated rehabilitation does not appear to be harmful Recent literature describes time based rehabilitation protocols that are mainly based on the remodeling process of the graft Since there is still uncertainty about the time schedule of the human remodeling process, it makes more sense to incorporate functional goal based criteria to the rehabilitation protocol The goal of a rehabilitation program after an ACL reconstruction is to regain mobility and muscle function and ultimately to return to sports participation ), so rehabilitation plays a significant role in determining how quickly and safely an athlete can return to sport There is a gap of evidences to determine the best approach to be used in physical therapy rehabilitation program following ACL reconstruction. We aim to investigate the effects of time-based rehabilitation program versus goal based rehabilitation program on knee function, range of motion, effusion grading scale, and pain
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anterior cruiate ligament reconstruction,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 18/07/2017
Actual trial start date 17/07/2017
Anticipated date of last follow up 03/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group goal based ACL rehabilitation protocol 5 times per week 22 weeks Consists of three phases with a goal-based progression: the so-called traffic-light method of progression through phases. This is relatively new in rehabilitation, but it assures a more patient-tailored rehabilitation. Patients can start with the next phase only if specific goals of the previous phase are achieved and these should be confirmed with objective tests. 20
Experimental Group time based ACL reconstruction rehabilitation protocol 5 times per week 22 weeks Phase 1 (week 1) Goal Modalities Control of pain and inflammation ¿ Cryotherapy ¿ exercises Obtain ROM and full extension ¿ patellar mobilization in all directions, ¿ heel slides 0-90° ¿ leg elevation with a pillow under the heel Regain muscle control Safe isometric and isotonic : Strength exercises without additional weight. ¿ OC (ROM 90°¿40°) ¿ CC (ROM 0¿60°) (i.e, SLR, mini squads, shiftin 20
Control Group traditional treatment 5 times per week 22 weeks Immediate weight bearing Should only be tolerated if there is a correct gait pattern (if necessary with crutches Cryotherapy First postoperative week to reduce pain Electric stimulation For re-educating voluntary contraction of the quadriceps muscles during the first postoperative weeks. Isometric quadriceps exercises First postoperative week for reactivating the quadriceps muscles when they prov 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Underwent pre-operative rehabilitation program with minimal knee effusion and full extension, good patellofemoral mobility, and the patient can actively control the quadriceps. ¿ Have an ACLR with an autolongous hamstring (HS) graft. ¿ Age rang from 18 ¿ 40 years old. ¿ Are football players or who perform physically demanding work. ¿ Have no other ligamentous injury. ¿ Have no partial meniscectomy previous to or simultaneously with ACLR. ¿ Have no cartilage damage classification. ¿ Patients younger than 18 or older than 40 years old ¿ Have ACLR with any graft other than hamstring (HS) graft ¿ Have ACL revision surgery ¿ Have other ligamentous injury ¿ Have a partial meniscectomy previous to or simultaneously with ACLR. ¿ Had meniscal repair simultaneously with ACLR ¿ Have cartilage damage. 18 Year(s) 40 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 13/07/2017 ethics committee of faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed alzayat street cairo 22672 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain one day pre treatment one day post treatment
Secondary Outcome limb symmetry index one day pre treatment and day post treatment
Secondary Outcome battery of hop test one day pre treatment and one day post treatment
Secondary Outcome dynamic knee valgus one day pre treatment one day post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic of faculty of physical therapy, cairo university 7 ahmed elzayat street cairo 22672 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
author own money 5 sabri abo allam street shebin elkoum 203457 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, cairo university 7 ahmed elzayat street cairo 22672 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Omar Elabd 5 sabri abo allam street shebin elkoum 203457 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Elabd 30marel3abd@gmail.com 00201098221045 5 sabri abo allam street
City Postal code Country Position/Affiliation
shebin elkoum 203472 Egypt faculty of physical therapy, cairo university
Role Name Email Phone Street address
Public Enquiries Omar Elabd 3omarel3abd@gmail.com 00201098221045 5 sabri abo allam street
City Postal code Country Position/Affiliation
shebin elkoum 203472 Egypt faculty of physical therapy, cairo university
Role Name Email Phone Street address
Scientific Enquiries Omar Elabd 3omarel3abd@gmail.com 00201098221045 5 sabri abo allam street
City Postal code Country Position/Affiliation
shebin elkoum 203472 Egypt faculty of physical therapy, cairo university
REPORTING
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