NCT05434767

Brief Summary

Despite best efforts to provide standardized and effective rehabilitation sessions post-total knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in this group of patients. There is a need to develop innovative rehabilitation strategies that (i) provide patients with accurate cues allowing for better compliance and exercise performance, (ii) allow for therapists to ensure continuity of care, monitor compliance, and identify deviation from recovery trajectories post-discharge, prior to their first outpatient appointment, and (iii) reduce reliance on manpower and variability during rehabilitation sessions. Technological solutions that empower patients and allow home-based rehabilitation to take place without the need for real-time human supervision could be the key to improving effectiveness and lowering costs. A mobile application which detects key landmarks on the body for human pose estimation will allow patients to perform their rehabilitation exercises with real-time feedback allowing for proper execution of the exercises. Physiotherapists will be able to access the data generated from the exercise session via a command centre to monitor patients' recovery progress and compliance. The primary aim of this pilot study is to evaluate the feasibility of using a mobile application during rehabilitation in patients after a TKR surgery. The secondary aim is to study the effects of using a mobile application during rehabilitation on knee functional status, exercise self-efficacy, and treatment satisfaction after TKR surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

June 15, 2022

Last Update Submit

December 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compliance

    Frequency of exercise sessions completed

    6 weeks post-surgery

Secondary Outcomes (11)

  • Knee range-of-motion

    Pre-operation; 6 weeks post-surgery

  • Gait speed

    Pre-operation; 6 weeks post-surgery

  • Knee Pain

    Pre-operation; 6 weeks post-surgery

  • 30 second sit to stand

    Pre-operation; 6 weeks post-surgery

  • Self-report physical function

    Pre-operation; 6 weeks post-surgery

  • +6 more secondary outcomes

Study Arms (2)

Standard rehabilitation program

ACTIVE COMPARATOR
Other: Standard rehabilitation program

Mobile application

EXPERIMENTAL
Device: Mobile application

Interventions

Participants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned exercises using the mobile application 3 times daily. Physiotherapists will still perform the required assessment/review, education, and intervention.

Mobile application

All participants will be seen by physiotherapists in the ward post-TKR surgery and undergo standard inpatient rehabilitation. Patients will be given instructions to perform assigned exercises 3 times daily. Physiotherapists will perform the required assessment/review, education, and intervention.

Standard rehabilitation program

Eligibility Criteria

Age45 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • Willingness to be randomized to either mobile application group or standard hospital-based rehabilitation group
  • Ability to provide informed consent
  • Is technologically savvy - at least 6 months' experience using a smartphone and able to key in data into a smartphone
  • English-speaking

You may not qualify if:

  • Rheumatoid arthritis and other systemic arthritis
  • A previous history of stroke and other major neurological conditions
  • An intention to transfer to step-down care facilities post-operatively or intention to continue outpatient physiotherapy service at another institution
  • Unable to perform 5 repetitions of inner-range quadriceps exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 28, 2022

Study Start

June 29, 2022

Primary Completion

October 20, 2023

Study Completion

November 20, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations