MedTrace Logo

The Use of the GRASP System for Postoperative Monitoring

NCT06825988 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-02-27

No results posted yet for this study

Summary

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.

Conditions

  • Knee Arthroplasty, Total
  • Rehabilitation

Interventions

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.

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Grasp AS

    collaborator UNKNOWN

  • Haukeland University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825988 on ClinicalTrials.gov