Completed

GRASP System for Postoperative Monitoring in Knee Arthroplasty

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What is being tested

Grasp

Device
Who is being recruted

From 30 to 70 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Early Phase 1
Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorHaukeland University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2023

Actual date on which the first participant was enrolled.

This study is focused on testing a new digital system called Grasp, which includes a handheld electronic device and a mobile app. The goal is to see how well this system works for monitoring pain and recovery outcomes after knee replacement surgery. The study targets patients who have undergone knee arthroplasty, aiming to improve how their recovery is tracked and managed. By understanding the feasibility and user experience of Grasp, the study hopes to refine the system for better support in monitoring postoperative progress, ultimately enhancing recovery experiences for patients. Participants in the study will use the Grasp system to report their pain levels and recovery progress after surgery. The study will evaluate the system's effectiveness by looking at how many people join the study, how well they follow the study instructions, and how successfully they complete the required tasks. The study will also gather feedback on user experience through questionnaires and interviews conducted after two and six weeks of use. This feedback will help identify areas for improvement in the system and the study design. There are no specific risks mentioned, but the study will provide valuable insights into making postoperative monitoring more effective and user-friendly.

Official TitleThe Use of the GRASP System for Postoperative Monitoring - a Feasibility Study
NCT06825988
Principal SponsorHaukeland University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Elective joint arthroplasty

Age: 30-70 years

Must own and be able to use a smart phone

Speak and understand Norwegian

1 exclusion criteria prevent from participating
Not able to give informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Grasp system (hardware and mobile application) during first 6 postsurgical weeks of rehabilitation. Subjects are instructed to report pain through squeezing the hardware in 3 different levels regulaly during the day, and, in addition enter answers to questions on patient reported outcome meassures (sleep quality, overall well-being, use of medication, appetit, physical activity) and register exercise time into the mobile application. Data entries will be presented as trajectories in graphs and charts in the app. At their 6 weeks physiotherapist consult, the physiotherapists will use the data during the consult.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Helse Bergen

Bergen, NorwayOpen Helse Bergen in Google Maps
CompletedOne Study Center