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

NCT06248034 | Unknown

• 1 other identifier: 2023/2482
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Arthropathy

Keywords

Knee Arthroplasty;; Orthopedic Procedures;; Outcome Assessments;; Self- Help Devices;; Technology;; Knee: Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Physical function:

  Pre-Operative, Week 12 & Week 24

• Muscle strength:

  Pre-Operative, Week 12 & Week 24

• Knee pain:

  Pre-Operative, Week 12 & Week 24

• Knee range-of-motion:

  Pre-Operative, Week 12 & Week 24

• Stair climb test:

  Pre-Operative, Week 12 & Week 24

Other Outcomes (7)

• Quality of the mobile application:

  Week 12 & Week 24

• Treatment credibility:

  Week 24

• Perceived usefulness and ease of use:

  Week 12 & Week 24

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Smartphone application with tele-monitoring rehabilitation 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 Smartphone Home-based Rehabilitation Program (N=15)

Hospital-based rehabilitation program 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.

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

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Rootally AI PTE LTD: collaborator

Central Study Contacts

Shuxian, Eleanor Chew

CONTACT

+65 9188 1404

Shuxian, Eleanor Chew

CONTACT

+65 6326 5302; eleanor.chew.s.x@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Physiotherapist

Model Details: 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).

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 8, 2024
• Study Start: February 15, 2024
• Primary Completion: June 1, 2024
• Study Completion: February 20, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share