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Clinical Trials/NCT06248034
NCT06248034
Not yet recruiting
Not Applicable

A Pilot Feasibility Study Comparing Smartphone Home-based Rehabilitation Program Against the Usual Hospital and Outpatient Physiotherapy Care on Clinical and Cost Effectiveness for Total Knee Replacement Patients.

Singapore General Hospital0 sites30 target enrollmentFebruary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthropathy
Sponsor
Singapore General Hospital
Enrollment
30
Primary Endpoint
Gait speed:
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Knee osteoarthritis (OA) is a common, chronic, and costly condition whilst total knee replacement (TKR) is a common orthopaedic surgical intervention. 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 smartphone home-based rehabilitation 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 randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of this innovative smartphone home-based exercise program versus that of currently standard, hospital-based outpatient rehabilitation program among post TKR patients in the Department of Physiotherapy, Singapore General Hospital.

Detailed Description

Thirty patients undergoing TKR for knee OA will be randomly assigned to receive either smartphone home-based rehabilitation program or hospital-based rehabilitation program following surgery for a rehabilitation period of 24 weeks. The primary patient functional outcome will be fast gait speed. Outcomes will be assessed preoperatively, at 12-week and 24-week after surgery by an assessor masked to group allocation. If shown to be non-inferior to the standard outpatient rehabilitation, smartphone home-based exercise program can be recommended as a cost effective treatment option for patients with TKR.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
February 20, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eleanor Chew Shuxian

Senior Principal Physiotherapist

Singapore General Hospital

Eligibility Criteria

Inclusion Criteria

  • Primary unilateral total knee replacement
  • Age \>= 45 years
  • Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
  • Able to ambulate independently without an assistive device
  • Willingness to be randomized to either smartphone home-based rehabilitation program or outpatient rehabilitation
  • Ability to provide informed consent
  • Able to operate phone application and use online platform
  • Able to read and understand English or Mandarin

Exclusion Criteria

  • Rheumatoid arthritis and other systemic arthritis
  • Significant back or other non-knee pain
  • A previous history of stroke and other major neurological conditions
  • An intention to transfer to step-down care facilities post-operatively

Outcomes

Primary Outcomes

Gait speed:

Time Frame: Pre-Operative, Week 12 & Week 24

This provides a performance-based measure of physical function. As participants walk a 10-metre walkway at their usual and fast pace.

Secondary Outcomes

  • 30 seconds-sit-to-stand test:(Pre-Operative, Week 12 & Week 24)
  • Knee range-of-motion:(Pre-Operative, Week 12 & Week 24)
  • Knee pain:(Pre-Operative, Week 12 & Week 24)
  • 5-repetition-sit-to-stand test:(Pre-Operative, Week 12 & Week 24)
  • Physical function:(Pre-Operative, Week 12 & Week 24)
  • Muscle strength:(Pre-Operative, Week 12 & Week 24)
  • Stair climb test:(Pre-Operative, Week 12 & Week 24)

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