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Trial registered on ANZCTR


Registration number
ACTRN12618000234213
Ethics application status
Approved
Date submitted
16/01/2018
Date registered
14/02/2018
Date last updated
14/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Feldenkrais Method in the Management of Pain, Function and Balance in People with Osteoarthritis of the Knee
Scientific title
The Feldenkrais Method in the Management of Pain, Function and Balance in People with Osteoarthritis of the Knee
Secondary ID [1] 293789 0
None
Universal Trial Number (UTN)
U1111-1207-7897
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 306189 0
Condition category
Condition code
Musculoskeletal 305301 305301 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 305409 305409 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feldenkrais Method:

The intervention will be gentle self-regulated ‘awareness through movement’ Feldenkrais Method sessions, guided by a Feldenkrais practitioner (also a podiatrist or physiotherapist) at the Western Sydney University campus.

The intervention includes 4 movement workshops of 3 hr duration, performed once per week. Intervention length is 1.5 hours, with the remainder of the time used for measurements and socialisation after the intervention.

The Feldenkrais intervention is delivered face to face by the practitioner, to groups of 2 to 6 participants. Target intensity is low, participants are advised they should be comfortable and able to talk easily at the correct level of intensity. There are regular rest periods between techniques.

All Feldenkrais sessions will be conducted in positions of support i.e seated position, or use of a back of a chair, or wall for support, to minimise falls risk.

Adherence is monitored by the number of times participants attend sessions. Observation of classes by practitioner also ensures participants are engaging in the activity.

This is a cross-over trial. After the intial 4 week intervention the intervention group has no more active intervention, but is followed up at 4 and 8 weeks post intervention.
Intervention code [1] 300043 0
Rehabilitation
Intervention code [2] 300044 0
Treatment: Other
Comparator / control treatment
Control group is normal physical activity.

Participants are asked to continue with any physical activity such as gardening, walking, tai chi etc they already undertaken. The IPEQ WA, is used to monitor physical activity at baseline, 4 week wait-list(controls), 4 week intervention, 4 week post intervention, 8 week post intervention.

This is a cross-over trial. After the intial 4 week period the control group recieved the active Feldenkrais intervention for 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 304461 0
Timed up and go (timed 3 metre walk, from a sitting position and return)
Timepoint [1] 304461 0
Week 1 (baseline), 4, 8 and 12 (primary endpoint)
Primary outcome [2] 304462 0
Sit to stand (number repetitions in 60s)
Timepoint [2] 304462 0
Week 1 (baseline), 4, 8 and 12 (primary endpoint)
Secondary outcome [1] 342027 0
Squat test (knee angle at onset of pain and time to do 5 reps),
Timepoint [1] 342027 0
Week 1, 4, 8 and 12.
Secondary outcome [2] 342028 0
Functional reach:
The test represents the difference between baseline arm length arm (90 degrees to the chest) and maximal forward reach with the same arm from a fixed standing position .
Timepoint [2] 342028 0
Week 1, 4, 8 and 12
Secondary outcome [3] 342029 0
Walking speed (walk 5 metres on gaitrite 2mm thick mat)
Timepoint [3] 342029 0
Week 1, 4, 8 and 12
Secondary outcome [4] 342030 0
Sway (stand on emed pressure plate 30s).
Timepoint [4] 342030 0
Week 1, 4, 8 and 12.
Secondary outcome [5] 342032 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [5] 342032 0
Week 1, 4, 8 and 12.
Secondary outcome [6] 342033 0
SF-36
Timepoint [6] 342033 0
Week 1, 4, 8 and 12.
Secondary outcome [7] 342034 0
Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [7] 342034 0
Week 1, 4, 8 and 12
Secondary outcome [8] 342333 0
Adverse Events
These are participant reported, e.g increased knee pain after testing, or falls during Feldenkrais class
Timepoint [8] 342333 0
During intervention

Eligibility
Key inclusion criteria
• Positive knee OA radiographic image of either both or one femoral tibial knee according to the clinical and radiographic criteria, Kellgren and Lawrence Scale, or clinical diagnoses according to the EULAR guidelines based on presence of three symptoms (pain on use, short-lived morning stiffness and functional limitation) and three signs of knee osteoarthritis (crepitus, restricted movement, and articular instability)
• Age 55 years or over.
• Independently walking with no ambulatory aids;
• Current/ recent knee pain.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-English literacy/speaking and/or impaired cognitive ability, thereby unable to understand instructions or provide informed consent
• Co-morbidities that restrict walking safety and capacity
• Impaired hearing with inability to hear instructions

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298406 0
University
Name [1] 298406 0
Western Sydney University
Country [1] 298406 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 297542 0
None
Name [1] 297542 0
Address [1] 297542 0
Country [1] 297542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299404 0
Western Sydney University Human Research Ethics Comittee
Ethics committee address [1] 299404 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Ethics committee country [1] 299404 0
Australia
Date submitted for ethics approval [1] 299404 0
29/05/2017
Approval date [1] 299404 0
11/07/2017
Ethics approval number [1] 299404 0
H12288

Summary
Brief summary
Knee osteoarthritis affects around 25% of adults over 55. While exercise is the recommended primary intervention, pain, deconditioning and fear of falling impacts on exercise adherence, and adds to the disability cycle. A feasibility study, using quantitative and qualitative methods, will be undertaken determining viability of a larger clinical trial. A Feldenkrais Method intervention, using guided ‘awareness through movement’ lessons, will be used aiming to minimise pain-related habitual patterns, and improve sensorimotor planning and mobility. Fifteen participants (55yrs+) will be recruited from the community and randomised to a control or intervention group, with a cross-over arm. Three to 4 movement workshops of ~ 3hrs duration will be undertaken, with a control physical activity diary. Pre/post and follow-up measures will be undertaken at week 1, 4, 8 and 12. Clinical and patient reported measures will be used, and exit focus group / interviews to evidence a larger robust clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80282 0
Dr Stefania Penkala
Address 80282 0
Building 24
Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country 80282 0
Australia
Phone 80282 0
+612 4620 3742
Fax 80282 0
Email 80282 0
[email protected]
Contact person for public queries
Name 80283 0
Dr Stefania Penkala
Address 80283 0
Building 24
Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country 80283 0
Australia
Phone 80283 0
+612 4620 3742
Fax 80283 0
Email 80283 0
[email protected]
Contact person for scientific queries
Name 80284 0
Dr Stefania Penkala
Address 80284 0
Building 24
Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country 80284 0
Australia
Phone 80284 0
+612 4620 3742
Fax 80284 0
Email 80284 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
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