Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement

Sponsor
Singapore General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05434767
Collaborator
(none)
30
2
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Mobile application
  • Other: Standard rehabilitation program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement: A Pilot Feasibility Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard rehabilitation program

Other: Standard rehabilitation program
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.

Experimental: Mobile application

Device: Mobile application
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.

Outcome Measures

Primary Outcome Measures

  1. Compliance [6 weeks post-surgery]

    Frequency of exercise sessions completed

Secondary Outcome Measures

  1. Knee range-of-motion [Pre-operation; 6 weeks post-surgery]

    A long-arm goniometer will be used to measure knee flexion and extension range-of-motion.

  2. Gait speed [Pre-operation; 6 weeks post-surgery]

    Usual and fast gait speed

  3. Knee Pain [Pre-operation; 6 weeks post-surgery]

    Knee will be measured using separate 11-point numeric pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain.

  4. 30 second sit to stand [Pre-operation; 6 weeks post-surgery]

    30 second sit to stand test

  5. Self-report physical function [Pre-operation; 6 weeks post-surgery]

    All items are scored on 5-point Likert scales. With100 indicating no symptoms and 0 indicating extreme symptoms.

  6. Self-efficacy [Pre-operation; 6 weeks post-surgery]

    Self-efficacy questionnaire

  7. Total contact time [6 weeks post-surgery]

    Time spent with the patients

  8. Quality of the mobile application [6 weeks post-surgery]

    Quality of the mobile application questionnaire. All items are scored on 5-point Likert scales with 1 indicating "Inadequate" and 5 indicating "Excellent".

  9. Participant satisfaction [6 weeks post-surgery]

    Participants will rate their satisfaction with treatment on an 11-point Likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".

  10. Treatment credibility [6 weeks post-surgery]

    Participants will rate their confidence about the benefits of the intervention on an 11-point Likert scale, with 0 indicating "not confident" and 10 indicating "extremely confident".

  11. Perceived usefulness and ease of use [6 weeks post-surgery]

    Participants will rate their perceived usefulness and ease of use of the intervention on an 11-point Likert scale, with 0 indicating "not useful or not easy" and 10 indicating "extremely useful or extremely easy".

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. Willingness to be randomized to either mobile application group or standard hospital-based rehabilitation group

  5. Ability to provide informed consent

  6. Is technologically savvy - at least 6 months' experience using a smartphone and able to key in data into a smartphone

  7. English-speaking

Exclusion Criteria:
  1. Rheumatoid arthritis and other systemic arthritis

  2. A previous history of stroke and other major neurological conditions

  3. An intention to transfer to step-down care facilities post-operatively or intention to continue outpatient physiotherapy service at another institution

  4. Unable to perform 5 repetitions of inner-range quadriceps exercise

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Singapore General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT05434767
Other Study ID Numbers:
  • 2021/2718
First Posted:
Jun 28, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 28, 2022