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

Total Knee Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434767
• Other study ID #: 2021/2718
• Status: Completed
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: December 2023
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty
• Total Knee Replacement

Intervention

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.

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.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Frequency of exercise sessions completed	6 weeks post-surgery
Secondary	Knee range-of-motion	A long-arm goniometer will be used to measure knee flexion and extension range-of-motion.	Pre-operation; 6 weeks post-surgery
Secondary	Gait speed	Usual and fast gait speed	Pre-operation; 6 weeks post-surgery
Secondary	Knee Pain	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.	Pre-operation; 6 weeks post-surgery
Secondary	30 second sit to stand	30 second sit to stand test	Pre-operation; 6 weeks post-surgery
Secondary	Self-report physical function	All items are scored on 5-point Likert scales. With100 indicating no symptoms and 0 indicating extreme symptoms.	Pre-operation; 6 weeks post-surgery
Secondary	Self-efficacy	Self-efficacy questionnaire	Pre-operation; 6 weeks post-surgery
Secondary	Total contact time	Time spent with the patients	6 weeks post-surgery
Secondary	Quality of the mobile application	Quality of the mobile application questionnaire. All items are scored on 5-point Likert scales with 1 indicating "Inadequate" and 5 indicating "Excellent".	6 weeks post-surgery
Secondary	Participant satisfaction	Participants will rate their satisfaction with treatment on an 11-point Likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".	6 weeks post-surgery
Secondary	Treatment credibility	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".	6 weeks post-surgery
Secondary	Perceived usefulness and ease of use	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".	6 weeks post-surgery