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Completed

NCT Number: NCT07572487

User Requirements of the Neurorehabilitation Ecosystem for Sustained Therapy

In this study the user requirements of the Neurorehabilitation Ecosystem for Sustained Treatment (NEST), a system containing: an exercise app, smartwatch and virtual coach designed for stroke survivors, will be investigated. Focus groups or interviews will be held in three countries, Italy, Spain and the Netherlands. During these focus groups open-ended questions will be asked about the different components of NEST.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

INRCA, Ancona, Italy

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About this study

After stroke, patients often experience a reduced arm-function. This function can partly be regained during a long and intensive rehabilitation. However, due to the ageing population and the increasing stroke cases, there is not enough time and money for this long and intensive rehabilitation in a rehabilitation center. Home-based rehabilitation could offer a solution to this problem. Currently, a new home-based rehabilitation system is being developed, named the Neurorehabilitation Ecosystem for Sustained Treatment (NEST). This system consists of three different components: an app, in which games can be played; a smartwatch which monitor the arm function of the patient and a virtual coach which will motivate the patient. However, this system is still being developed and it is unknown whether it meets the user requirements.

Therefore, the goal of this study is to identify factors for NEST to maximize usability, acceptance and usefulness by stroke patients, therapists and caregivers in the home situation. We conducted a qualitative focus group study, with 5 patients, 5 caregivers and 5 therapists in each of the three centers in Italy, Spain and the Netherlands. In each of the three centers, 3 focus groups or interviews will take place; one with patients, one with caregivers and one with therapists. First an introduction will be given in which the participants will see a video of NEST. Then questions about the systems will be asked. In total this will take 2 hours with a 30-minute break for patients. The main objective of this study is to get a list with factors that NEST needs to fulfill in order for it to be used by patients, caregivers and therapists. This will come out of an inductive thematic analysis from the focus groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Stroke survivors:

Inclusion criteria

  • People who had a stroke and were discharged from the rehabilitation center within one year from now.
  • Range of different hand functioning measured with the Fugl-Meyer Assessment (only the upper extremity part will be used)
  • 18 years or older

Exclusion criteria

  • Low cognitive functioning, with a mini mental state examination score below 21
  • Extremely limited smartphone user
  • Patients suffering from aphasia

Caregivers:

Inclusion criteria

  • An informal caregiver of a stroke patient (mostly a family member or friend)
  • Stroke patient was discharged within one year from now
  • 18 years or older

Exclusion criteria

  • Extremely limited smartphone user

Healthcare professionals:

Inclusion criteria

  • Working as a therapist in one of the centres
  • Working with stroke patients on a daily basis

Exclusion criteria

  • Extremely limited smartphone user

Treatment and study plan

Primary outcomes

  1. Inductive thematic analysis on user requirements gained during focus groups

    Time frame: 2 hours

    Focus groups will be held. One with stroke survivors, one with caregivers and one with healthcare professionals. The researcher will be the leader.

  2. Inductive thematic analysis on user requirements gained during interviews

    Time frame: 1 hour

    Interviews between the researcher and either stroke survivors, caregivers or healthcare professionals.

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Collaborators

  • Hospital Vall d'Hebron
  • ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT

Registry information

Official study title

User Requirements of the Neurorehabilitation Ecosystem for Sustained Therapy (NEST): an Integrated Home-based Rehabilitation Tool

Acronym: NEST

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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