Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00662493




Registration number
NCT00662493
Ethics application status
Date submitted
15/04/2008
Date registered
21/04/2008
Date last updated
21/04/2008

Titles & IDs
Public title
A Comparison of Two Exercise Programs on Knee Motor Control
Scientific title
The Effect of Specific Versus Generalised Quadriceps Exercise on Neural Control of the Vasti
Secondary ID [1] 0 0
020077
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Pain 0 0
Patellofemoral Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Motor control retraining program
BEHAVIORAL - Quadriceps strengthening program

Experimental: 1 - Motor control retraining program


BEHAVIORAL: Motor control retraining program
Specific retraining of VMO activation in a low-load situation,and progressed to integrate more functional positions. Use of dual channel biofeedback was incorporated

BEHAVIORAL: Quadriceps strengthening program
4 exercises focused on quadriceps strengthening commencing at a resistance of 60% 1 repetition maximum. Each exercise was performed for 3 sets of 10 repetitions
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
latency between the onset of VMO electromyographic activity relative to that of VL during stair ascent and stair descent measured using surface electrodes
Timepoint [1] 0 0
6 weeks with 8 week followup
Secondary outcome [1] 0 0
Concentric and eccentric quadriceps muscle strength as assessed by isokinetic dynamometry
Timepoint [1] 0 0
6 weeks with 8 week followup

Eligibility
Key inclusion criteria
* aged between 16-40 years, with the upper age limit to reduce the likelihood of osteoarthritic changes in the patellofemoral joint
* a self-reported history of anterior or retropatellar knee pain with insidious onset of symptoms and with at least one episode of pain in the past 12 months where pain was aggravated by at least two of the following: prolonged sitting, stairs, squat, running, kneeling and hopping/jumping
* currently asymptomatic for at least 8 weeks prior to assessment
* delay in the onset of VMO EMG relative to that of VL of greater than 10 ms during either the ascent or descent of a stair stepping task
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* current knee pain
* history of knee surgery or other knee injury in previous 12 months
* physiotherapy treatment for knee pain in the past 12 months
* history of patellar dislocation/subluxation
* clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis and spinal referred pain
* current lower limb pathology affecting their ability to satisfactorily complete the testing or exercise protocol
* current use of non-steroidal anti-inflammatory or corticosteroid drugs
* inability to communicate and comprehend written or verbal instructions in English

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kim L Bennell, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00662493