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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Device: Smartphone application with tele-monitoring rehabilitation; Procedure: Hospital-based rehabilitation program

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuxian, Eleanor Chew; Phone Number: +65 9188 1404
• Study Contact Backup: Name: Shuxian, Eleanor Chew; Phone Number: +65 6326 5302; Email: eleanor.chew.s.x@sgh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed:	This provides a performance-based measure of physical function. As participants walk a 10-metre walkway at their usual and fast pace.	Pre-Operative, Week 12 & Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function:	The physical function will be measured using the subscale of Knee Osteoarthritis Outcome Score (KOOS) and Global Rating Scale, which are designed to evaluate the patient's opinion about their knee and associated problem.	Pre-Operative, Week 12 & Week 24
Muscle strength:	One-repetition Maximum(1RM) is a measure of the maximal weight a participant can lift with one repetition.	Pre-Operative, Week 12 & Week 24
Knee pain:	Knee pain intensity while navigating stairs, walking, standing and performing a sit-to-stand will be measured using the 10-point numeric pain rating scales (NPRS). 0 - No pain 10 - Extremely painful	Pre-Operative, Week 12 & Week 24
Knee range-of-motion:	A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position.	Pre-Operative, Week 12 & Week 24
Stair climb test:	This assesses the participants' ability to ascend and descend stairs, their lower limb strength, balance and endurance. The timing required for participants to ascend one flight of stairs, turn around and descend the same flight of stairs will be taken. The stair climb test is a measure that is performed as part of standard clinical practice.	Pre-Operative, Week 12 & Week 24
5-repetition-sit-to-stand test:	A test to assess participants' ability to rise from a chair and return to the sitting position. The time taken for participant to stand up and sit down five times as fast as possible from standard chair (43-47cm) without the use of their hands will be recorded. This test is a measure that is performed as part of standard clinical practice and is also a measure of lower limb strength and dynamic balance.	Pre-Operative, Week 12 & Week 24
30 seconds-sit-to-stand test:	A test to assess participants' ability to rise from a chair and return to the sitting position within 30seconds from standard chair (43-47cm) without the use of their hands will be recorded.	Pre-Operative, Week 12 & Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the mobile application:	The Mobile Application Rating Scale:user version (uMARS) will be used to measure the quality of the application. This scale assesses the engagement, functionality, and aesthetics of the application. 1- Strongly disagree 5- Strongly agree	Week 12 & Week 24
Treatment credibility:	Treatment credibility will be measured using the treatment credibility scale. Participants will rate their confidence about the benefits of the intervention on a 11-point Likert scale, with 0 indicating "not confident" and 10 indicating "extremely confident".	Week 24
Perceived usefulness and ease of use:	These measures will be measured on a 10-point numeric scale. 0 - Not at all satisfied 10-Extremely satisfied	Week 12 & Week 24
Participants satisfaction:	Immediately post intervention at 12-week and at 24-week time-point, participants will rate their satisfaction with rehabilitation on a 20-cm visual analogue scale, with 0 cm indicating "no satisfaction" and 20 cm indicating "complete satisfaction".	Week 12 & Week 24
EQ5D-5L:	The EQ5D-5L is a standardised instrument to measure health related quality of life in cost-effectiveness analysis.	Week 12 & Week 24
Adverse effects:	The adverse effects for participants randomized to the hospital-based rehabilitation group would be, such as falls or reports of injuries during the exercises, they will be monitored by questioning participants at each outpatient visit by the treating physiotherapists. For participants randomized to the smartphone home-based group, weekly exercise outcome reports will be sent to a research coordinator. Based on regular reports of participant's knee range-of-motion, 5-repetition-sit-to-stand, ability to perform exercises and activities, the physiotherapist will provide hospital-based rehabilitation to participants who are deemed to have deviated from the expected course of recovery and are at risk for poor functional outcomes.	Week 24
Implementation outcomes:	The feasibility and acceptability of implementing the smartphone home exercise program will be evaluated. Specifically, the investigators will compute the proportion of eligible patients and evaluate the reasons for non-participation. Study participants will be asked to indicate, prior to surgery, their preference for the mode of treatment (smartphone home-based exercise program or hospital-based rehabilitation). Immediately post intervention at the 24-week time-point, participants will rate their satisfaction with home exercise program.	Week 12 & Week 24

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Rootally AI PTE LTD

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): February 20, 2025

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Knee Arthroplasty;; Orthopedic Procedures;; Outcome Assessments;; Self- Help Devices;; Technology;; Knee: Treatment Outcome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2023/2482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No