The Use of the GRASP System for Postoperative Monitoring

NCT06825988 | Completed Early Phase 1

• 2 other identifiers: 634183Pilot Helse
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

digital health; tangible interaction; postoperative monitoring; rehabilitation; knee arthroplasty; mixed methods; feasibility

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Grasp system

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.

Device: Grasp

Interventions

Grasp DEVICE

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.

Grasp system

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: gender definitions is not an exclusion criteria of this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not able to give informed consent

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator
• Grasp AS: collaborator

Study Sites (1)

Helse Bergen

Bergen, 5021, Norway

Location

MeSH Terms

Interventions

Hand Strength

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 13, 2025
• Study Start: November 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 27, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2023-2038
• Access Criteria: All documents are available on request

Locations

NO (1)