NCT06119230

Brief Summary

Post-stroke participants will wear wearable sensors for one week at 1-week prior to discharge from inpatient rehabilitation, 3- and 7- weeks post-discharge and 3-months post-discharge. All participants will wear sensors but only participants in the intervention group will receive sensor-informed activity feedback (e.g., activity, sleep and sedentary behaviour) and feedback informed goal setting sessions with a physiotherapist. The feedback forms will be co-created with physiotherapists working at GF Strong. Focus group(s) will be conducted to collect the opinions of clinicians with respect to measures to be included in the feedback form. At 3-months post-discharge, participants will be interviewed regarding their experience with the sensors. This study will explore the feasibility and initial benefits of using wearable sensors paired with goal setting to assist in the maintenance of activity levels during a difficult period for stroke survivors (transitioning home from rehab).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 17, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

2.2 years

First QC Date

May 17, 2023

Last Update Submit

August 28, 2026

Conditions

Stroke

Keywords

Wearable sensorsStroke Rehabilitationinertial measurement unitsactivity counselling

Outcome Measures

Primary Outcomes (6)

  • Recruitment Rate

    \# of participants per month

    Baseline

  • Sensor Wear Adherence

    Participant adherence to wearing sensors

    From enrolment to end of study

  • Participant Adherence to Intervention

    \# of activity counselling sessions attended by the participants

    From enrolment to end of study

  • Acceptability of sensors for remote monitoring and intervention

    semi-structured interviews

    3 months post-discharge

  • Technical Issues/Events

    \# of issues that occurs with the remote monitoring equipment

    From enrolment to end of study

  • Adverse Events

    \# of adverse events

    From enrolment to end of study

Secondary Outcomes (4)

  • Timed Up and Go (TUG) Test

    Baseline and 3 months

  • 10 Meter Walk Test

    Baseline and 3 months

  • Action Research Arm Test (ARAT)

    Baseline and 3 months

  • 6 Minute Walk Test

    Baseline and 3 Months

Study Arms (2)

Sensors only

NO INTERVENTION

Participants will only wear the sensors for a one week period during the 4 different time points.

Sensors and Activity Counselling

EXPERIMENTAL

Participants will wear the sensors for a one week period and receive a goal setting session with a physiotherapist at baseline, 3-and 7-weeks post discharge.

Behavioral: Activity Counselling

Interventions

Activity CounsellingBEHAVIORAL

Participants will receive a one hour goal setting session with a physiotherapist where they will use the feedback forms to create activity goals for the upcoming week of collection.

Sensors and Activity Counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physiotherapists for focus group participation
  • Age of 18 or older
  • Registered Physiotherapist at GF Strong (inpatient or outpatient)
  • year of work experience in stroke rehabilitation (acute or chronic)
  • Patient Group
  • Age of 18 or older
  • Had a stroke resulting in hemiparesis
  • English speaking or living with an English-speaking family member to assist with interpretation/goal setting with PT

You may not qualify if:

  • Physiotherapist Focus Group:
  • \- \<1 year of experience in stroke rehabilitation
  • Patient Group:
  • \- presents with any other unstable medical conditions that would impact activity (e.g., unstable cardiac condition, recent fracture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2023

First Posted

November 7, 2023

Study Start

February 1, 2024

Primary Completion

April 23, 2026

Study Completion

April 23, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations

CA(1)