The Use of the GRASP System for Postoperative Monitoring

The Use of the GRASP System for Postoperative Monitoring - a Feasibility Study

The aim of this study is to explore feasibility and user experience of a novel digital system containing a handheld electronic device and a mobile application - called Grasp - in the setting of postoperative monitoring of pain and patient reported outcome measures in knee arthroplasty patients.

The investigators will use a mixed-methods approach to gain in-depth insights into feasibility and user experience of this system in order to evaluate further improvement needs of both study design and intervention before a final randomised effect study. Feasibility will be evalutated through recruittment rates, adhererance to intervention protocol and study data sampling, and completion rates. Fidelity will be assessed as number of patients who are able to do as instructed in the protocol. In addition, the investigators will explore user experience through questionnaires after 2 and 6 weeks of use and through semi-structered interviews of participants and associated physiotherapists. Interviews will be transcribed for qualitative analyses.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Knee Arthroplasty, Total
• Intervention / Treatment: Device: Grasp

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Helse Bergen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective joint arthroplasty
• Age: 30-70 years
• Must own and be able to use a smart phone
• Speak and understand Norwegian

Exclusion Criteria:

• Not able to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Grasp system; 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.

Device: Grasp; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention study	Feasibility of the intervention study will be evalutated through adhererance to intervention protocol. It will be assessed as number of patients who are able to do as instructed in the protocol. Fidilty >80% will be considered high, 50-80% moderate, and <50% low. The investigators expect a priori the adherance to protocol guidelines to decline during the 6 weeks intervention period	From enrollment to 6 weeks after surgery
User experience	Mixed methods approach will be used to evaluate user experience. The investigators will make a mixed methods synthsis between participants questionnaires (by 2 and 6 weeks of intervention) and semi-structured interviews of up to 10 participants and associated physiotherapists by the end of the intervention period.	From enrollment to 6 weeks post surgery

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen; Grasp AS

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; feasibility; digital health; knee arthroplasty; postoperative monitoring; mixed methods; tangible interaction
• Other Study ID Numbers: 634183; Pilot Helse (Other Grant/Funding Number: Norwegian Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2023-2038
• IPD Sharing Access Criteria: All documents are available on request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No