Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000346572
Ethics application status
Approved
Date submitted
17/07/2006
Date registered
14/08/2006
Date last updated
14/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telerehabilitation for patients with total knee replacement.
Scientific title
Internet-based outpatient telerehabilitation for patients with total knee replacement is as effective as traditional face-to-face therapy for improving physical and functional patient outcomes. A randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty 1317 0
Condition category
Condition code
Musculoskeletal 1402 1402 0 0
Physical Medicine / Rehabilitation 1403 1403 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Outpatients participated in either a telerehabilitation once a week for a period of six weeks. The telerehabilitation program involved participants receiving their rehabilitation program via a videoconference established across an internet link using a custom built telerehabilitation system. As no physical contact between therapist and patient was possible across the link, the rehabilitation program consisted of self-applied techniques under the supervision of the remote therapist and a customised exercise program to adress the participants specific rehabilitation needs.
Intervention code [1] 1206 0
Rehabilitation
Comparator / control treatment
Outpatients participated in a traditional face-to-face therapy program once a week for a period of six weeks. Face-to-face therapy consisted of tradational one-on-one rehabilitation in the hospital outpatients department.
Control group
Active

Outcomes
Primary outcome [1] 1920 0
1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [1] 1920 0
Measured at the beginning and the end of the study period
Primary outcome [2] 1921 0
2. The Patient Specific Functional Scale
Timepoint [2] 1921 0
Measured at the beginning and the end of the study period
Primary outcome [3] 1922 0
3. The Spitzer Quality of Life Uniscale
Timepoint [3] 1922 0
Measured at the beginning and the end of the study period
Primary outcome [4] 1923 0
4. The timed up-and-go test
Timepoint [4] 1923 0
Measured at the beginning and the end of the study period
Primary outcome [5] 1924 0
5. Pain intensity, using a visual-analogue scale
Timepoint [5] 1924 0
Measured at the beginning and the end of the study period
Secondary outcome [1] 3378 0
1. Active and passive knee flexion angle and knee extension angle.
Timepoint [1] 3378 0
Measured at the beginning of each treatment session.
Secondary outcome [2] 3379 0
2. Quadriceps muscle strength.
Timepoint [2] 3379 0
Measured at the beginning of each treatment session.
Secondary outcome [3] 3380 0
3. Limb girth measurements to assess swelling in the knee.
Timepoint [3] 3380 0
Measured at the beginning of each treatment session.
Secondary outcome [4] 3381 0
4. Assessment of gait (Gait Assessment Rating Scale).
Timepoint [4] 3381 0
Measured at the beginning and the end of the study period.

Eligibility
Key inclusion criteria
1. Healthy subjects with no concomitant medical conditions that would prevent them from participating in a physical rehabilitation program (e.g. severe chronic obstructive pulmonary disease)2. Adult subjects who could provide informed consent. 3. Normal mentation with the ability to accurately follow commands4. Uni-compartmental, unilateral or bilateral total knee replacement. May have a fully constrained, semi-constrained or unconstrained prosthesis 5. Common surgical approach for total knee replacement including: medial parapatellar arthrotomy technique, subvastus arthrotomy technique or trivector-retaining arthrotomy technique6. The ability to attend physiotherapy rehabilitation for a minimum period of six weeks post operatively7. Ability to at least partially weight-bear.8. Ability to participate voluntarily and provide signed informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant medical conditions such as malignancy, which may interfere with the normal rehabilitation process2. Medical conditions that may interfere with balance, such as Parkinson’s disease, or conditions in which the performance of an open kinetic chain, inner-range quadriceps contraction against resistance is contraindicated, such as anterior cruciate ligament surgery3. Inability to walk with or without a walking aid4. Inability to speak and write in English 5. Inability to refrain from receiving any additional therapy for their knee during the six-week intervention period apart from prescribed medication therapy.

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)
Sealed Envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized code: Fixed block size with stratification to intervention therapist
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A therapist with no other involvement in the study and who was blinded to the method of intervention performed all pre- and post-intervention patient outcome measures. Due to the nature of the interventions, neither subject nor treating therapist blinding was possible.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/11/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1536 0
Government body
Name [1] 1536 0
Australian Postgraduate Award
Country [1] 1536 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 1350 0
University
Name [1] 1350 0
University of Queensland
Address [1] 1350 0
Country [1] 1350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2966 0
Princess Alexandria Hospital Human Research Ethics Committee acting on behalf of the QEII Jubilee Hospital, Brisbane, Australia. Approved on 02/08/2002. HREC ID Number:
Ethics committee address [1] 2966 0
Ethics committee country [1] 2966 0
Australia
Date submitted for ethics approval [1] 2966 0
Approval date [1] 2966 0
02/08/2002
Ethics approval number [1] 2966 0
77/02
Ethics committee name [2] 2967 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 2967 0
Ethics committee country [2] 2967 0
Australia
Date submitted for ethics approval [2] 2967 0
Approval date [2] 2967 0
08/01/2003
Ethics approval number [2] 2967 0
2002000379

Summary
Brief summary
This prospective randomised controlled trial will evaluate the efficacy of providing outpatient physiotherapy rehabilitation to patients via a low-bandwidth Internet-based telerehabilitation system. Possitive outcomes will pave the way for remotely delivered rehabilitation programs via the Internet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35330 0
Address 35330 0
Country 35330 0
Phone 35330 0
Fax 35330 0
Email 35330 0
Contact person for public queries
Name 10395 0
Dr Trevor Russell
Address 10395 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
Therapies Building
St Lucia QLD 4072
Country 10395 0
Australia
Phone 10395 0
+61 7 33469633
Fax 10395 0
+61 7 33652775
Email 10395 0
[email protected]
Contact person for scientific queries
Name 1323 0
Dr Trevor Russell
Address 1323 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
Therapies Building
St Lucia QLD 4072
Country 1323 0
Australia
Phone 1323 0
+61 7 33469633
Fax 1323 0
+61 7 33652775
Email 1323 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.