Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02103907|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : June 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Targeted dynamic balance training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
No Intervention: Wait list
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).
Experimental: Treatment (balance training)
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.
Other: Targeted dynamic balance training
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).
- 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.
- Change in knee pain from baseline [ Time Frame: 0, 10 weeks ]Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
- Change in fear of pain from baseline [ Time Frame: 0, 10 weeks ]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.
- Change in self-reported physical activity level from baseline [ Time Frame: 0, 10 weeks ]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.
- Change in knee joint proprioception from baseline [ Time Frame: 0, 10 weeks ]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.
- Change in muscle strength from baseline [ Time Frame: 0, 10 weeks ]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.
- Change in knee joint range of motion from baseline [ Time Frame: 0, 10 weeks ]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.
- Ratio of number of exercise sessions attended to the maximum [ Time Frame: 10 weeks ]Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.
- Number of participants with adverse events [ Time Frame: 10 weeks ]Adverse events experienced due to the intervention (i.e. increased knee pain) will be recorded weekly by participants.
- Change in medication use [ Time Frame: 10 weeks ]Any change in pharmacological use by participants will be recorded.
- Change in co-interventions [ Time Frame: 10 weeks ]Other therapies that participants may be pursuing will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103907
|Canada, British Columbia|
|Motion Analysis and Biofeedback Laboratory, The University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Principal Investigator:||Michael A Hunt, PT, PhD||University of British Columbia|