Knee OsteoarthritisNCT02103907
Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
A study testing Targeted dynamic balance training in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults. Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Targeted dynamic balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
- predominance of pain/tenderness over the medial (inside) region of the knee
Who cannot join
- articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
- inflammatory arthritic condition
- history of knee or hip replacement surgery
- recent use of corticosteroids (oral or via injection, within last 6 months)
- pain originating predominantly from the patellofemoral joint
- inability to ambulate without a gait aid
Show all 10Show fewer
- non-English speaking
- recent (within 6 months) arthroscopic knee surgery
- significant hip or back pain (limits the ability to perform the testing)
- Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Motion Analysis and Biofeedback Laboratory, The University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis
There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults. Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA. There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results. Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function. If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life. The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA. This will be a randomized controlled trial (RCT).
- Conditions
- Knee Osteoarthritis
- Being tested
- Targeted dynamic balance training
- Keywords
- balance, knee, osteoarthritis, physical function
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted dynamic balance trainingOther
Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks. Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete. Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).
| Study group | Role | What they receive |
|---|---|---|
| Wait list | No intervention | Wait list control group. Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period. Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks). |
| Treatment (balance training) | Experimental | Targeted dynamic balance training. Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception. Exercises will be performed four times per week for ten weeks. Exercises will be taught and supervised by a trained kinesiologist. Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises. Exercises will be progressed to different exercises in each new phase (total 3 phases). Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week. All other sessions will be performed at home. Receives: Other: Targeted dynamic balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dynamic balance and mobility from baseline
The Community Balance and Mobility Scale (CB\&M) will be used to assess dynamic balance and mobility. The CB\&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor. The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
Measured: 0, 10 weeks
Change in self-reported physical function from baseline
The Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function. The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
Measured: 0, 10 weeks
Secondary outcomes (6)
Change in knee pain from baseline
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Measured: 0, 10 weeks
Change in fear of pain from baseline
The Brief Fear of Movement Scale will be used to assess fear of pain. This scale is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The scale has been validated in individuals with OA.
Measured: 0, 10 weeks
Change in self-reported physical activity level from baseline
The Physical Activity Scale for the Elderly score (PASE) will be used to measure self-reported physical activity level. This valid and reliable self-report instrument measures the type and level of recreational and occupational physical activity in the previous week.
Measured: 0, 10 weeks
Change in knee joint proprioception from baseline
Knee joint proprioception will be measured using a knee joint repositioning task, previously used in those with OA to assess joint proprioception. Proprioception will be assessed in three randomly chosen target positions (15°, 30°, and 60° of knee flexion) while the participant is seated on an isokinetic dynamometer.
Measured: 0, 10 weeks
Change in muscle strength from baseline
Maximal concentric and eccentric muscle strength of the plantarflexors, quadriceps, and hamstrings will be measured using the same isokinetic dynamometer as for the knee joint repositioning task.
Measured: 0, 10 weeks
Change in knee joint range of motion from baseline
Range of motion will be measured using a goniometer, similar to other studies of knee OA. Participants will be asked to flex and extend their knee joint while supine.
Measured: 0, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Health Professions Association
- Responsible party
- Sponsor
- Investigators
- Michael A Hunt, PT, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103907
- Sponsor's protocol ID
- H14-00587
- Other IDs
- AHPA-TAS- 14-001
- Status last verified
- Jun 2016
- First submitted
- 1 Apr 2014
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Takacs J, Krowchuk NM, Garland SJ, Carpenter MG, Hunt MA. Dynamic Balance Training Improves Physical Function in Individuals With Knee Osteoarthritis: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1586-1593. doi: 10.1016/j.apmr.2017.01.029. Epub 2017 Mar 6.
PubMed 28279661
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02103907
- Acronym / sponsor ID
- H14-00587
- Conditions
- Knee Osteoarthritis
- Keywords
- balance, knee, osteoarthritis, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Arthritis Health Professions Association
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults. Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA. There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results. Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function. If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life. The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA. This will be a randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait list | No intervention | –Wait list control group. Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period. Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks). |
| Treatment (balance training) | Experimental | Other: Targeted dynamic balance trainingTargeted dynamic balance training. Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception. Exercises will be performed four times per week for ten weeks. Exercises will be taught and supervised by a trained kinesiologist. Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises. Exercises will be progressed to different exercises in each new phase (total 3 phases). Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week. All other sessions will be performed at home. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
- predominance of pain/tenderness over the medial (inside) region of the knee
Key exclusion criteria (10 listed)
- articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
- inflammatory arthritic condition
- history of knee or hip replacement surgery
- recent use of corticosteroids (oral or via injection, within last 6 months)
- pain originating predominantly from the patellofemoral joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted dynamic balance trainingParticipants in this study group will complete dynamic balance training exercises four times per week, for ten weeks. Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete. Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out). | Other | Treatment (balance training) |
Primary outcome
Change in dynamic balance and mobility from baseline
Time frame: 0, 10 weeks
The Community Balance and Mobility Scale (CB\&M) will be used to assess dynamic balance and mobility. The CB\&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor. The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
Change in self-reported physical function from baseline
Time frame: 0, 10 weeks
The Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function. The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
6 secondary outcomes
Change in knee pain from baseline
Time frame: 0, 10 weeks
Change in fear of pain from baseline
Time frame: 0, 10 weeks
Change in self-reported physical activity level from baseline
Time frame: 0, 10 weeks
Change in knee joint proprioception from baseline
Time frame: 0, 10 weeks
Change in muscle strength from baseline
Time frame: 0, 10 weeks
Change in knee joint range of motion from baseline
Time frame: 0, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Derived from this study: PubMed 28279661Takacs J, Krowchuk NM, Garland SJ, Carpenter MG, Hunt MA. Dynamic Balance Training Improves Physical Function in Individuals With Knee Osteoarthritis: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1586-1593. doi: 10.1016/j.apmr.2017.01.029. Epub 2017 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Hunt, PT, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted dynamic balance training in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dynamic balance and mobility from baseline (time frame: 0, 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.