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Community-based Rehabilitation and Fall Prevention Program After Total Knee Arthroplasty

Effectiveness of a Community-based Post-operative Rehabilitation and Fall Prevention Program Following Total Knee Arthroplasty - a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615638
Enrollment
78
Registered
2018-08-06
Start date
2018-10-01
Completion date
2021-12-31
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Knee Osteoarthritis

Keywords

Fall prevention, Total knee arthroplasty, Commnuity-based

Brief summary

Knee osteoarthritis (OA) is a common musculoskeletal disorder among older people. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population. Total knee arthroplasty (TKA) is used to treat patients with severe knee OA. While TKA has been shown to improve knee pain, function and quality of life of patients with knee OA, up to 50% of patients with post-TKA may suffer from falls within in the first year after TKA. Given that Tai Chi can significantly improve the balance and function of older people, a fall prevention program may improve balance, pain, and function of post-TKA patients. As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA against a group of TKA patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Detailed description

Osteoarthritis (OA) is the third most disabling musculoskeletal compliant in the world. Knee OA is the most common type of OA. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population. Total knee arthroplasty (TKA) is a surgical intervention for treating patients with severe knee OA. Research has found that TKA reduces knee pain, and improves patient's function and quality of life. However, studies have also found that patients with post-TKA may be more likely to fall as compared to age- and gender-matched asymptomatic counterparts. It is estimated that around 20% to 50% of patients fall within in the first year after TKA. As such, it is essential to improve the balance of post-TKA patients. Studies have found that Tai Chi can significantly improve the balance and function of older people. Therefore, a fall prevention program aiming at strengthening, proprioception, balance training, and behavioral modification may improve balance, pain, and function of post-TKA patients. As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA with a group of patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Interventions

12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)

Sponsors

Neuroscience Research Australia
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The orthopedic surgeons, outcomes assessor and statistician will be blinded.

Intervention model description

Single-blinded 3-arm randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participants undergoing TKA for intervention group and usual postoperative care group * Age- and gender-matched asymptomatic controls without knee pain in the last 12 months. * Can speak and understand Cantonese/English.

Exclusion criteria

* Living in assisted living facilities, requiring nursing care * Medical 'red flag' conditions * A history of cancer in the last five years * Cauda equine syndrome * Knee fracture * Auto-immune disease (e.g. rheumatoid arthritis) even if they have OA * Inflammatory or septic arthritis * Systemic disease * Amputation * History of orthopedic or neurological surgery to the spine, pelvis or hips * Neurological diseases (e.g. stroke or Parkinson's disease) * Mini-Mental State Examination score \< 24 * Depression subscale score of Depression Anxiety Stress Scales \> 21 * Severe comorbidity leading to severe deterioration of quality of life or major healthcare utilization * Osteochondritis dissecans * Perthes' disease * Plica disease * Baker's cyst

Design outcomes

Primary

MeasureTime frameDescription
Chinese version of Knee Injury and Osteoarthritis Outcome Scale1 yearA 42-item questionnaire with 5 subscales to assess pain, symptoms, activities of daily living, sports and recreation function, and knee-related quality of life

Secondary

MeasureTime frameDescription
Chinese version Falls Efficacy Scale - International1 yearTo examine a person's confidence in avoiding a fall during 16 non-threatening activities of daily living.
Number of post-operative trips/falls1 yearTo quantify the number of trips/falls over 1 year after TKA
11-point numeric pain rating scale1 yearThis scale quantify pain on a scale of 0 to 10. Higher the scores, higher the pain intensity
Chinese version Insomnia Severity Index1 yearIt assesses sleep problems and related difficulties
Physical Activity Scale for the Elderly1 yearIt evaluates leisure, physical, household and work-related activities over the last 7 days
Chinese version geriatric depression scale1 yearIt consists of 15 questions to assess depression in older people

Countries

Hong Kong

Contacts

Primary ContactArnold Wong, PhD
arnold.wong@polyu.edu.hk852-2766-6741

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026