Innovative Tele-monitored Home-Based Program for Post Total Knee Replacement Rehabilitation: A Noninferiority Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- Singapore General Hospital
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Difference in Fast-paced gait speed
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.
The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.
Detailed Description
Study Hypotheses Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3 and at 6 months after total knee replacement (TKR) in improving physical function (fast gait speed). Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3 and at 6 months after TKR in improving knee pain, physical impairments, and health-related quality of life. Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs Approach and Methods This will be an assessor-blinded, parallel design, non-inferiority randomised controlled trial, with assessments preoperatively(baseline), 3 months, and 6 months after total knee replacement surgery. The protocol conforms to the CONSORT guidelines for non-inferiority randomized controlled trials. Post TKR, all participants will undergo daily inpatient rehabilitation. At discharge, they will be given a standard booklet with advice on ice therapy and home exercises to be performed. Two weeks post TKR, randomization will occur and participants will be randomised to receive either the telemonitored home exercise program or the hospital-based rehabilitation program.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary unilateral total knee replacement
- •Age \>= 45 years
- •Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
- •Ability to provide informed consent
Exclusion Criteria
- •Further lower limb joint replacement surgery anticipated within the next 6 months
- •Rheumatoid arthritis and other systemic arthritis
- •A previous history of stroke and other major neurological conditions
- •An intention to transfer to step-down care facilities post-operatively.
Outcomes
Primary Outcomes
Difference in Fast-paced gait speed
Time Frame: Pre-operation; 3 months and 6 months post-surgery
Difference in fast gait speed (over 10 metres) between the two treatment groups.
Secondary Outcomes
- Knee Pain: Numeric Pain Rating Scale (NPRS)(Pre-operation; 3 months and 6 months post-surgery)
- STarT Back Screening Tool(Pre-operation; 3 months and 6 months post-surgery)
- 30s chair stand test(Pre-operation; 3 months and 6 months post-surgery)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Pre-operation; 3 months and 6 months post-surgery)
- Treatment credibility(3 months post-surgery)
- Quadriceps muscle strength(Pre-operation; 3 months and 6 months post-surgery)
- Treatment satisfaction: scale(3 months post-surgery)
- Knee range-of-motion(Pre-operation; 3 months and 6 months post-surgery)
- EuroQol-5 Dimensions (EQ-5D-5L) descriptive system(Pre-operation; 3 months and 6 months post-surgery)
- Cost(3 months and 6 months post-surgery)
- Örebro Musculoskeletal Pain Screening Questionnaire (short form)(Pre-operation; 3 months and 6 months post-surgery)