NCT07572487

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 18, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

focus groupinterviewuser requirementshome-based rehabilitationstroke

Outcome Measures

Primary Outcomes (2)

  • Inductive thematic analysis on user requirements gained during focus groups

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

    2 hours

  • Inductive thematic analysis on user requirements gained during interviews

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

    1 hour

Study Arms (3)

Stroke survivors

Stroke survivors with an affected upper limb function due to stroke

Caregivers

Caregivers who support a stroke survivor in their close environment

Healthcare professionals

Healthcare professionals with experience in working with stroke survivors on a daily basis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All healthcare professionals worked at the participating centres. All stroke survivors received or were still receiving treatment at the participating centres. Most caregivers were related to the participating stroke survivors or recruited via social media.

You may qualify if:

  • 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)
  • years or older

You may not qualify if:

  • Low cognitive functioning, with a mini mental state examination score below 21
  • Extremely limited smartphone user
  • Patients suffering from aphasia
  • Caregivers:
  • An informal caregiver of a stroke patient (mostly a family member or friend)
  • Stroke patient was discharged within one year from now
  • years or older
  • \- Extremely limited smartphone user
  • Healthcare professionals:
  • Working as a therapist in one of the centres
  • Working with stroke patients on a daily basis
  • \- Extremely limited smartphone user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

INRCA

Ancona, Italy

Location

Sint Maartenskliniek

Ubbergen, Netherlands

Location

Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Noël Keijsers, Prof

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2024

First Posted

May 7, 2026

Study Start

January 15, 2022

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

May 7, 2026

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Due to the nature of the data (interviews and focus groups) it is not possible to provide complete anonymized data.

Locations