Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103907
• Other study ID #: H14-00587
• Secondary ID: AHPA-TAS- 14-001
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: June 5, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).

Locations

Country	Name	City	State
Canada	Motion Analysis and Biofeedback Laboratory, The University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Health Professions Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ratio of number of exercise sessions attended to the maximum	Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.	10 weeks	No
Other	Number of participants with adverse events	Adverse events experienced due to the intervention (i.e. increased knee pain) will be recorded weekly by participants.	10 weeks	Yes
Other	Change in medication use	Any change in pharmacological use by participants will be recorded.	10 weeks	No
Other	Change in co-interventions	Other therapies that participants may be pursuing will be recorded.	10 weeks	No
Primary	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.	0, 10 weeks	No
Primary	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.	0, 10 weeks	No
Secondary	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).	0, 10 weeks	No
Secondary	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.	0, 10 weeks	No
Secondary	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.	0, 10 weeks	No
Secondary	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.	0, 10 weeks	No
Secondary	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.	0, 10 weeks	No
Secondary	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.	0, 10 weeks	No