Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000378325
Ethics application status
Approved
Date submitted
1/03/2017
Date registered
13/03/2017
Date last updated
16/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does patella taping alter the degree of knee motion during functional tasks in individuals with anterior knee pain?
Scientific title
Effect of patella taping on knee kinematics in individuals with Patellofemoral Pain Syndrome. A Crossover design study
Secondary ID [1] 291213 0
Ni known
Universal Trial Number (UTN)
U1111-1193-2452
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain syndrome 302135 0
Condition category
Condition code
Musculoskeletal 301747 301747 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301929 301929 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kinematic analysis of the knee joint of individuals with Patellofemoral pain syndrome using 3D analysis software ( KneeKG infrared tracking device (Emovi Medical) while performing 3 functional activities - walking, step down and single leg squat, at Baseline (untaped) with Dynamic Taping (Intervention A) and with Rigid tape (Intervention B). Each taping application will be specific to the individuals requirements.
Baseline measure- following application of the exoskeleton harness, a habitulisation period of 2 minutes walking on the treadmill (to acclimitise to the harness placement and the treadmill walking action) and calibration of the knee KG system(which takes about 5 minutes maximum and requires the individual to move their leg in a variety of directions) the individual will be analysed performing the following 3 tasks.
1. walking at a comfortable speed on a treadmill for 45 seconds. 2 tests were completed
2. stepping down from a 20cm block with unharnessed leg to floor and returning repeatedly for 15 seconds and a slow and steady pace. 2 repeat tests carried out
3. Single leg squats for 15 seconds. 2 tests also.
The intervention order will predetermined by the participation number and was randomly generated using a computer program
That taping technique was then applied by the assessor.
Intervention A Involves the application of Dynamic tape(TM) which is a new concept sports tape composed of synthetic stretch nylon and lycra cloth with a choice of 4 techniques deemed appropriate for the individuals requirements depending on their biomechanics, neuromuscular deficiencies and patella alignment. Once the 1st Intervention (A or B) has completed the individual can either remove the tape immediately or keep it on and remove it 12 hrs prior to the 2nd testing session
Intervention B will be the application of rigid sports tape which has a Rayon construction with rubber zinc oxide adhesive material. This will be used in combination with hypoallergenic tape as an underlay, such as Fixomull.. The application is based on the McConnell Taping principle where the patella is repositioned and held by the tape. It will include medial glide, medial tilt and medial rotation as required for the participants presentation.
The 3 functional tasks as performed in the baseline measure were repeated immediately and then again on another day with a minumum of 12 hour washout period between the interventions
Testing occurs in the Physiotherapy Department at Prince of Wales Hospital and is carried out by the principal investigator who has 20 + yrs experience as a musculoskeletal physiotherapist.
Once the 1st Intervention (A or B) has been completed the individual can either remove the tape immediately or keep it on and remove it a minumum of 12 hrs prior to the 2nd testing session.
Intervention code [1] 297219 0
Treatment: Other
Intervention code [2] 297384 0
Treatment: Devices
Comparator / control treatment
Baseline (Untaped) kinematic analysis of knee joint motion during 3 functional tasks of walking, stepping down and performing a single leg squat
Control group
Active

Outcomes
Primary outcome [1] 301146 0
Knee Flexion/extension values during the gait cycle while walking at a comfortable speed, stepping down and while performing a single leg squat using the Knee KG 3 D analysis unit and EMOVI software
This is a composite primary outcome
Timepoint [1] 301146 0
Following a 2 minute walk on the treadmill to get used to the harness and the walking conditions of the treadmill. Baseline assessment (untaped therefore control) will be completed. Then the 3 functional tests will be repeated immediately following application of either Intervention A and Intervention B tape and then again following at least 12 hours washout period prior to the application of the 2 nd taping material
Primary outcome [2] 301147 0
Knee Abduction/adduction values during the gait cycle while walking at a comfortable speed, stepping down and while performing a single leg squat using the Knee KG 3 D analysis unit and EMOVI software
This is a composite primary outcome
Timepoint [2] 301147 0
Following a 2 minute walk on the treadmill to get used to the harness and the walking conditions of the treadmill. Baseline assessment (untaped therefore control) will be completed. Then the 3 functional tests will be repeated immediately following application of either Intervention A and Intervention B tape and then again following at least 12 hours washout period prior to the application of the 2 nd taping material
Primary outcome [3] 301148 0
Knee Rotation values during the gait cycle while walking at a comfortable speed, stepping down and while performing a single leg squat using the Knee KG 3 D analysis unit and EMOVI software
Timepoint [3] 301148 0
Following a 2 minute walk on the treadmill to get used to the harness and the walking conditions of the treadmill. Baseline assessment (untaped therefore control) will be completed. Then the 3 functional tests will be repeated immediately following application of either Intervention A and Intervention B tape and then again following at least 12 hours washout period prior to the application of the 2 nd taping material
Secondary outcome [1] 331869 0
pain to be assessed during performance of functional task using a Visual analogue scale (VAS)
Timepoint [1] 331869 0
Following habitulisation of walking on the treadmill, and calibration of the Knee KG system the VAS scale will be verbally noted while the participant performs each of the 3 functional tasks at baseline (untaped-Control) then again with the inclusion of Intervention A (Dynamic tape) and Intervention B

Eligibility
Key inclusion criteria
Any individual presenting with anterior knee pain exacerbated by 2 or more of the following activities – walking, running, jumping, ascending or descending stairs, static quads contraction, prolonged knee flexion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of any other knee pathology including Knee OA, patella #, patella dislocation, ligamentous, soft tissue injury or previous knee surgery, recent physiotherapy intervention including taping application or previous skin reaction to adhesive tape

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of intervention order using a randomisation table created by computer software was included
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: n=30 patients per treatment group. This number is based on the detection of a mean difference in the dependent variables of approximately 20%, a significance level of 5% and a power of 0.8. This number is a reflection also of the stated accuracy of the measurement systems employed in this study (lustig et al, 2012).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/10/2016
Date of last participant enrolment
Anticipated
29/09/2017
Actual
23/01/2018
Date of last data collection
Anticipated
6/10/2017
Actual
23/01/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7511 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 15335 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 295666 0
University
Name [1] 295666 0
University of New South Wales
Country [1] 295666 0
Australia
Primary sponsor type
Individual
Name
Kerri Blyth
Address
Physiotherapy department
Prince of wales Hospital
High Street, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 294514 0
Individual
Name [1] 294514 0
Professor William Walsh
Address [1] 294514 0
Surgical and Orthopaedic Research Lab
Prince Of Wales Hospital
Barker Street
Randwick, NSW, 2031
Country [1] 294514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296975 0
SOUTH EASTERN SYDNEY LOCAL HEALTH DISTRICT - HUMAN RESEARCH ETHICS COMMITTEE (HREC)
Ethics committee address [1] 296975 0
Ethics committee country [1] 296975 0
Australia
Date submitted for ethics approval [1] 296975 0
30/09/2015
Approval date [1] 296975 0
30/11/2015
Ethics approval number [1] 296975 0
14/261

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72598 0
Ms Kerri Blyth
Address 72598 0
Physiotherapy Department
Level 1 High Street
Prince of wales Hospital
Randwick
NSW, 2031
Country 72598 0
Australia
Phone 72598 0
+61 2 9382 5900
Fax 72598 0
+61 2 9382 5903
Email 72598 0
[email protected]
Contact person for public queries
Name 72599 0
Kerri Blyth
Address 72599 0
Physiotherapy Department
Level 1 High Street
Prince of wales Hospital
Randwick
NSW, 2031
Country 72599 0
Australia
Phone 72599 0
+61 2 9382 5900
Fax 72599 0
+61 2 9382 5903
Email 72599 0
[email protected]
Contact person for scientific queries
Name 72600 0
Kerri Blyth
Address 72600 0
Physiotherapy Department
Level 1 High Street
Prince of wales Hospital
Randwick
NSW, 2031
Country 72600 0
Australia
Phone 72600 0
+61 2 9382 5900
Fax 72600 0
+61 2 9382 5903
Email 72600 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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