Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000406303
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
20/03/2017
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Knee strengthening exercises after ACL reconstruction
Scientific title
Comparison of two knee strengthening protocols after ACL reconstruction: a cluster randomized controlled trial
Secondary ID [1] 290483 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL reconstruction 300861 0
Condition category
Condition code
Musculoskeletal 300683 300683 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rehabilitation protocol with knee strengthening exercises performed with the hip in neutral position (see attached protocol on the ANZCTR website). The intervention will be delivered on an individual basis, face to face at a physical therapy clinic by licensed physical therapists. The treatment will last for 6 months, starting 2 weeks after surgery with sessions for 3 times per week for the first 2 postoperative months, reduced to twice per week for the next 2 months and reduced to once a week for the final two months. The attendance to the prescribed sessions will be documented by the clinic. Each session will last 30-60 minutes depending on the rehabilitation phase. As described in detail in the protocol, the treatment involves manual therapy techniques, range of motion exercises, strengthening exercises, proprioceptive exercises, and sports-specific activities,
Intervention code [1] 296341 0
Rehabilitation
Comparator / control treatment
Rehabilitation protocol with knee strengthening exercises performed in the traditional seated position with the hip at 90 degrees of flexion (see attached protocol on the ANZCTR website). The intervention will be delivered on an individual basis, face to face at a physical therapy clinic by licensed physical therapists. The treatment will last for 6 months, starting 2 weeks after surgery with sessions for 3 times per week for the first 2 postoperative months, reduced to twice per week for the next 2 months and reduced to once a week for the final two months. The attendance to the prescribed sessions will be documented by the clinic. Each session will last 30-60 minutes depending on the rehabilitation phase. As described in detail in the protocol, the treatment involves manual therapy techniques, range of motion exercises, strengthening exercises, proprioceptive exercises, and sports-specific activities,
Control group
Active

Outcomes
Primary outcome [1] 300103 0
Isokinetic flexion peak torque by a Cybex isokinetic dynamometer
Timepoint [1] 300103 0
3, 4, 6 and 9 months post-surgery
Primary outcome [2] 300104 0
IKDC
Timepoint [2] 300104 0
3, 4, 6 and 9 months post-surgery
Secondary outcome [1] 329049 0
KOOS
Timepoint [1] 329049 0
3, 4, 6 and 9 months post-surgery
Secondary outcome [2] 329050 0
hop tests
Timepoint [2] 329050 0
3, 4, 6 and 9 months post-surgery
Secondary outcome [3] 329051 0
Tegner activity level
Timepoint [3] 329051 0
3, 4, 6 and 9 months post-surgery
Secondary outcome [4] 329052 0
compliance with exercises via a weekly exercise log
Timepoint [4] 329052 0
3, 4, 6 and 9 months post-surgery
Secondary outcome [5] 329053 0
Isokinetic extension peak torque with a Cybex isokinetic dynamometer
Timepoint [5] 329053 0
3, 4, 6 and 9 months post-surgery

Eligibility
Key inclusion criteria
ACL reconstruction with quadruple hamstrings graft
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a previous injury or operation to either knee, simultaneous fracture, concurrent ligamentous injury, evidence of osteoarthritis on radiograph, or articular cartilage lesions that required treatment. Patients with meniscal tears that were repaired were excluded, whereas those with tears that required no treatment or were treated with partial meniscectomy were included.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
cluster randomisation by computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
cluster randomisation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
14 participants in each group are needed to detect a large effect size with 80% power at a level of 0.05. To account for loss to follow-up we plan to recruit 16 participants in each group. Linear mixed models will be employed to investigate the effect of group allocation on the primary and secondary outcomes at 3, 4, 6, and 9 months

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
2/04/2018
Actual
Date of last data collection
Anticipated
4/03/2019
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 8376 0
Greece
State/province [1] 8376 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 294899 0
Other
Name [1] 294899 0
Rehabilitation and Physiotherapy Centre
Country [1] 294899 0
Australia
Primary sponsor type
Individual
Name
Evangelos Pappas
Address
University of Sydney, 75 East str, Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 293737 0
None
Name [1] 293737 0
Address [1] 293737 0
Country [1] 293737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296276 0
General Hospital Papanikolaou
Ethics committee address [1] 296276 0
Ethics committee country [1] 296276 0
Greece
Date submitted for ethics approval [1] 296276 0
14/08/2014
Approval date [1] 296276 0
27/08/2014
Ethics approval number [1] 296276 0
958/14.08.2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1584 1584 0 0
/AnzctrAttachments/371670-ACLR protocol for both groups ANZCTR.pdf (Protocol)

Contacts
Principal investigator
Name 69738 0
A/Prof Evangelos Pappas
Address 69738 0
University of Sydney, 75 East str, Lidcombe, NSW 2141
Country 69738 0
Australia
Phone 69738 0
+61293519188
Fax 69738 0
Email 69738 0
[email protected]
Contact person for public queries
Name 69739 0
Evangelos Pappas
Address 69739 0
University of Sydney, 75 East str, Lidcombe, NSW 2141
Country 69739 0
Australia
Phone 69739 0
+61293519188
Fax 69739 0
Email 69739 0
[email protected]
Contact person for scientific queries
Name 69740 0
Evangelos Pappas
Address 69740 0
University of Sydney, 75 East str, Lidcombe, NSW 2141
Country 69740 0
Australia
Phone 69740 0
+61293519188
Fax 69740 0
Email 69740 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.