Telerehabilitation of Patients After Knee Surgery

Knee Osteoarthritis Clinical Trial

Official title:

Future Patient - Telerehabilitation of Patients After Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731208
• Other study ID #: N-20180012
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is aimed to investigate the feasibility of employing communication and sensor technologies for the patient after a knee operation.

In the study, it is hypothesized that the effectiveness of postoperative rehabilitation programs might be improved by establishing electronic communication between healthcare professionals and the patients. It is also believed that users satisfaction and patients quality of life will be improved.

The telerehabilitation program promises a synchronized communication as well as an individualized training program (by health professionals) based on the patient's electronic reports.

Description:

Aim The objectives of this project are to assess the feasibility of using a telerehabilitation program for patients after a knee operation and investigate the acceptance of the provided solution by the patients and healthcare professionals.

Hypothesis It is hypothesized that the acceptance and satisfaction of patients and healthcare professionals by using the telerehabilitation program will be high and correlated with patients' exercise adherence and health recovery.

Telerehabilitation Group (Target Group) The subjects will be recruited before the operation and will be followed during an 8-week rehabilitation period.

In addition to the telerehabilitation program, the subjects will receive the regular treatment offered by Farsø Hospital in connection with total knee replacement surgery and are to follow the same rehabilitation procedure as regular patients (see below).

Before the operation, the project physiotherapist will hand over the telerehabilitation system equipment and instruct the subject how to use the system. In addition, the physiotherapist will also ask the subject to follow the instruction process and try the available services a few times. The physiotherapist makes sure that the subject can operate the system easily and without any challenges.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2020
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged over 18

• Successful primary total knee replacement surgery at Farsø Hospital

• Referred to the regular rehabilitation program (self-training at home) by the physiotherapists at Farsø Hospital

• Ability to walk (with or without walking aids)

• Able to use electronic technologies and devices (for example: smart phone, tablet) or at least one relative who can assist in this matter

• Living in The North Denmark Region

Exclusion Criteria:

• Previous or current drug addiction defined as the use of cannabis, opioids or other drugs

• Previous or current neurologic, musculoskeletal or mental illnesses

• Any other aggravating medical complication (such as infection or DVT)

• Lack of ability to understand and accept trial procedures

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Telerehabilitation
The telerehabilitation program equipment consists of the following devices: a tablet with a keyboard and a fingerprint sensor two wearable sensors a wireless modem measuring tape

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg
Denmark	Aalborg University Hospital	Farsø

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of the telerehabilitation program: semi-structured interview	The data is collected by a semi-structured interview	The interview is conducted two weeks after discharge.
Primary	Exercise adherence	Measured by telerehabilitation system reports	Everyday, started after discharge and for period of 8-weeks
Secondary	Self-reported pain, stiffness, and physical function: KOOS	Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)	After discharge (weeks 2, 8)
Secondary	Self-reported pain and physical function: OKS	measured by an electronic version of Oxford Knee Score (OKS)	Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
Secondary	Self-reported pain: VAS	Measured by an electronic report of the visual analog scale (VAS) of pain [minimum 0, Maximum 10] higher values represent a higher level of pain	Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Secondary	Self-reported knee swelling	measured by an electronic report of knee circumference	Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Secondary	Quality of life: EQ-5D	Measured using Euro Quality of Life - 5 Dimension (EQ-5D)	After discharge (weeks 2, 8)
Secondary	Users satisfaction: semi-structured interview	Measured by semi-structured interview	The interview is conducted two weeks after discharge.