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Completed

NCT Number: NCT05434767

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

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.

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Key information

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mobile application

Device

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.

Standard rehabilitation program

Other

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.

Primary outcomes

  1. Compliance

    Time frame: 6 weeks post-surgery

    Frequency of exercise sessions completed

Secondary outcomes

  1. Knee range-of-motion

    Time frame: 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

    Time frame: Pre-operation; 6 weeks post-surgery

    Usual and fast gait speed

  3. Knee Pain

    Time frame: 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

    Time frame: Pre-operation; 6 weeks post-surgery

    30 second sit to stand test

  5. Self-report physical function

    Time frame: 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

    Time frame: Pre-operation; 6 weeks post-surgery

    Self-efficacy questionnaire

  7. Total contact time

    Time frame: 6 weeks post-surgery

    Time spent with the patients

  8. Quality of the mobile application

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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