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Trial registered on ANZCTR


Registration number
ACTRN12616001343493
Ethics application status
Approved
Date submitted
2/09/2016
Date registered
26/09/2016
Date last updated
26/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Preoperative Physiotherapy and Rehabilitation on functional Outcomes in Patients undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.
Scientific title
Evaluation of Preoperative Physiotherapy and Rehabilitation on functional Outcomes in Patients undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Tria
Secondary ID [1] 289846 0
None
Universal Trial Number (UTN)
U1111-1187-1966
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament tear 299783 0
Physiotherapy 300306 0
Preoperative Physiotherapy 300307 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299714 299714 0 0
Physiotherapy
Injuries and Accidents 300111 300111 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seventy-two patients will be randomly selected and divided into one of two groups.
Arm1 will be consisted of 37 participants both sexes with aged 18 to 60 years. In this group 4 week (10 session) physiotherapy programme before ACL reconstruction will be applied.
In this group physiotherapy will be applied by physiotherapist who has 10 years of experience in ACL injury treatment. The physiotherapy program will be applied in medical sport injury clinic. Each of 10 sesion will be applied by 2 hours of kinesiotherapy (special individual exercise for ACL injury patients based on EBM - Evidence Based Medicine).
The aim of kinesiotherapy before ACL reconstruction will be to resolve knee impairments related to swelling and ROM (range of motion) deficits, restore muscle strength and adequate neuromuscular responses (prioprocepition). Both single and multiple joint exercises, open and closed kinetic chain exercises, as well as concentric, eccentric, and isometric strength exercises, will be included. the intensity of the exercise performed, will be 12-14/16 RPE (The Borg Rating of Perceived Exertion). The kinesiotherapy program will be individualized based on the specific needs of each patient. All patients will be supervised 2-3 times a week throughout the program to assure that the intendent quality of performance and correct level of dificullty was achieved. Compliance will be monitored through medical records of each subject and register of attendance at exercise sessions.

Arm2 will be consisted of 35 participants both sexes with aged 18-60. In this group there will not be the physiotherapy before ACL reconstruction.
In this group patients will have only instructions on home-based physiotherapy (self exercise at home). This instructions will be applied face to face (physiotherapist-patient).

The two study groups will be comperable in term of BMI, age side of injury, activity level, time from injury to operation and functional status by Lysholm Scale.
Intervention code [1] 295825 0
Rehabilitation
Comparator / control treatment
In this group there will not be the physiotherapy programme before ACL reconstruction.
In this group patients will have only instructions on home-based physiotherapy (self exercise at home). This instructions will be applied face to face (physiotherapist-patient) about ACL injury and physiotherapy before and after ACL reconstruction (based on EBM).
This information will be applied in simply way that the exercise of ACL injury knee could be done at home but no specific instructions will be given. Approximate duration of the instruction session will be about one hour.
Control group
Active

Outcomes
Primary outcome [1] 299528 0
The primary outcome {1} will be: Functional status assessed using the KOOS questionnaire. (Knee Injury and Osteoarthritis Outcome Score)
Timepoint [1] 299528 0
The Assessment will be taken 6 and 12 weeks after ACL reconstruction
Primary outcome [2] 299592 0
The primary outcome {2} will be: Pain assessed with VAS scale
Timepoint [2] 299592 0
The assesment will be taken 6 and 12 weeks after ACL reconstruction.
Primary outcome [3] 299593 0
The primary outcome {3} will be: Knee joint range of motion measurment (using goniometr)
Timepoint [3] 299593 0
The assesment will be taken 6 and 12 weeks after ACL reconstruction.
Secondary outcome [1] 327764 0
The secondary outcome will be functional status assessed using the KOOS questionnaire 2 years after ACL reconstruction
Timepoint [1] 327764 0
2 years after ACL reconstruction

Eligibility
Key inclusion criteria
Patients with complete ACL tear, who undergo single bundle ACL reconstruction procedure.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age<18 and age >60. contraindications for apllying physiotherapy, other relevant dysfunctions within the musculoskeletal system, lack of conscious conforms to participate in the study

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)
The experimental (Arm1) and placebo group (Arm2) allocations will be determinated according to randomized codes.
Main coordiantor who will allocate the particpants to groups will have opaque, sealed envelopes. Each will be contained a piece of paper marked with code 1 or code 2
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
The experimental group (Arm1) will receive code1 and code2 for placebo group (Arm2). The particpants would select and open an envelope in the presence of a physiotherapis to see the symbol and would then direct the patient to the corresponding group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/02/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2014
Date of last data collection
Anticipated
31/12/2016
Actual
30/06/2016
Sample size
Target
72
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 8184 0
Poland
State/province [1] 8184 0
Warsaw

Funding & Sponsors
Funding source category [1] 294456 0
Self funded/Unfunded
Name [1] 294456 0
Sebastian Zdunski
Country [1] 294456 0
Poland
Primary sponsor type
Individual
Name
Sebastian Zdunski
Address
Departament of Physiotherapy, II Faculty of Medicine, Medical University of Warsaw. Zwirki i Wigury 61. 02-091 Warsaw, Poland
Country
Poland
Secondary sponsor category [1] 293321 0
Individual
Name [1] 293321 0
Witold Rongies
Address [1] 293321 0
Departament of Physiotherapy. Rehabilitation Division. II Faculty of Medicine. Medical University of Warsaw. Zwirki i Wigury 61. 02-091. Warsaw. Poland
Country [1] 293321 0
Poland
Secondary sponsor category [2] 293322 0
Individual
Name [2] 293322 0
Janusz Sierdzinski
Address [2] 293322 0
Departament of Medical Information Technology and Telemedicine Medical University of Warsaw. Bancha 1a. 02-097 Warsaw. Poland.
Country [2] 293322 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295890 0
Bioeethics Committee of Medical University of Warsaw
Ethics committee address [1] 295890 0
Ethics committee country [1] 295890 0
Poland
Date submitted for ethics approval [1] 295890 0
Approval date [1] 295890 0
13/02/2013
Ethics approval number [1] 295890 0
KB/35/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1083 1083 0 0
/AnzctrAttachments/371236-Bioethics Committee of the Medical University of Warsaw.pdf (Ethics approval)

Contacts
Principal investigator
Name 68002 0
Dr Sebastian Zdunski
Address 68002 0
Departament of Physiotherapy. Rehabiltation Division. II Faculty of Medicine. Medical University of Warsaw. Zwirki i Wigury 61. 02-091
Country 68002 0
Poland
Phone 68002 0
+48 501 262 416
Fax 68002 0
Email 68002 0
sebastian.zdunski@gmail.com
Contact person for public queries
Name 68003 0
Sebastian Zdunski
Address 68003 0
Departament of Physiotherapy. Rehabiltation Division. II Faculty of Medicine. Medical University of Warsaw. Zwirki i Wigury 61. 02-091
Country 68003 0
Poland
Phone 68003 0
+48 501 262 416
Fax 68003 0
Email 68003 0
sebastian.zdunski@gmail.com
Contact person for scientific queries
Name 68004 0
Witold Rongies
Address 68004 0
Departament of Physical Therapy and Rehabilitation, II Faculty of Medicine. Medical University of Warsaw, Zwirki i Wigury 61. 02-091
Country 68004 0
Poland
Phone 68004 0
+48 604 538 380
Fax 68004 0
+48 22 599 15 63
Email 68004 0
rongies@interia.pl

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
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Documents added automatically
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