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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-02-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The investigators will perform stratified randomization by surgeons, are evenly distributed between the 2 treatment arms. Arm 1: Smartphone Home-based Rehabilitation Program (N=15); Arm 2: Hospital-based rehabilitation program (N=15).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

To reduce bias, the research assistant collecting assessment data will be blinded to treatment allocation. Participants will also be instructed not to reveal details about their group assignment to the outcome assessor to maintain blinding.

Study Groups

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Participants for Smartphone Home-based Rehabilitation Program (N=15)

Study participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic.

Group Type EXPERIMENTAL

Smartphone application with tele-monitoring rehabilitation

Intervention Type DEVICE

This Smartphone application includes an automated criterion-based progression based on participant's regular recorded self-measurement of knee range-of-motion and five-repetition-sit-to-stand. The rehabilitation program is designed to (i) increase knee range-of-motion, (ii) strengthen lower limb strength, (iii) improve postural balance, and (iv) improve physical function.

Participants for Hospital-based rehabilitation program (N=15)

Study participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic.

Group Type EXPERIMENTAL

Hospital-based rehabilitation program

Intervention Type PROCEDURE

Participants will be provided with the usual preoperative, inpatient physiotherapy and a physiotherapy house visit within the first 2-weeks postoperation. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion.

Interventions

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Smartphone application with tele-monitoring rehabilitation

This Smartphone application includes an automated criterion-based progression based on participant's regular recorded self-measurement of knee range-of-motion and five-repetition-sit-to-stand. The rehabilitation program is designed to (i) increase knee range-of-motion, (ii) strengthen lower limb strength, (iii) improve postural balance, and (iv) improve physical function.

Intervention Type DEVICE

Hospital-based rehabilitation program

Participants will be provided with the usual preoperative, inpatient physiotherapy and a physiotherapy house visit within the first 2-weeks postoperation. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes