Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 1:32 AM
Study NCT ID:
NCT06248034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Singapore General Hospital
Organization:
Study Overview
Official Title:
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: