NCT03731208

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2018

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

September 22, 2018

Last Update Submit

July 7, 2020

Conditions

Knee Osteoarthritis

Keywords

Quality of lifeTelerehabilitationKnee rehabilitationKnee OsteoarthritisTotal Knee Replacement

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Exercise adherence

    Measured by telerehabilitation system reports

    Everyday, started after discharge and for period of 8-weeks

Secondary Outcomes (6)

  • Self-reported pain, stiffness, and physical function: KOOS

    After discharge (weeks 2, 8)

  • Self-reported pain and physical function: OKS

    Baseline (before operation), and after discharge (weeks 0,2,4,6,8)

  • Self-reported pain: VAS

    Baseline (before operation), and every third day after discharge (for period of 8 weeks)

  • Self-reported knee swelling

    Baseline (before operation), and every third day after discharge (for period of 8 weeks)

  • Quality of life: EQ-5D

    After discharge (weeks 2, 8)

  • +1 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation

Device: Telerehabilitation

Interventions

TelerehabilitationDEVICE

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aalborg University

Aalborg, 9220, Denmark

Location

Aalborg University Hospital

Farsø, 9640, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Laboratory for Welfare Technologies - Telehealth & Telerehabilitation, Integrative Neuroscience Research Group, SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark

Study Record Dates

First Submitted

September 22, 2018

First Posted

November 6, 2018

Study Start

May 1, 2018

Primary Completion

July 15, 2019

Study Completion

July 1, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No plan for sharing protocol was considered.

Locations

DK(2)