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StrokeNCT06119230

The Active Transition Home Post-Stroke Program

A study testing Activity Counselling in people with Stroke, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Activity Counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
1 Feb 2024to 23 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Physiotherapists for focus group participation
  • Age of 18 or older
  • Registered Physiotherapist at GF Strong (inpatient or outpatient)
  • 1 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • GF Strong Rehabilitation Centre

    Vancouver, British Columbia, V5Z 2G9

Other trials in Canada

About this study

Official title: The Active Transition Home Program: Use of Wearable Sensors to Increase Activity Levels Following Discharge Home From Stroke Rehabilitation

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).

Read the detailed description

Purpose: This study will explore the benefits of using wearable sensor informed feedback and associated goal setting sessions for increasing activity levels during the transition home from stroke rehab.

Hypothesis: The investigators hypothesize that 1) wearable sensors are a feasible intervention for monitoring activity levels during the transition home, 2) participants receiving activity feedback and goal setting sessions will maintain higher activity levels compared to participants who only receive standard of care and 3) participants will report an overall positive experience with the use of sensor-informed feedback and goal setting sessions during the first 3 months of their transition.

Justification: The feasibility of using wearable sensor informed feedback and goal setting sessions has not yet been explored during the transition from inpatient stroke rehabilitation to home. This is an important period for recovery. Evidence shows that the first six months post-stroke are foundational to forming healthy activity patterns that encourage continued recovery, prevent the occurrence of poor secondary health outcomes, recurrent stroke, and optimize quality of life.

Objectives: The objectives will be to 1) explore the feasibility of using sensor-informed activity feedback to guide the establishment of activity patterns during the transition, 2) evaluate the preliminary efficacy of sensor-informed activity feedback to improve activity patterns during the transition and 3) qualitatively explore the perceptions of patients regarding their experiences with the wearable sensors and associated activity feedback forms for daily activity tracking.

Research Design: This study is a feasibility randomized control trial (RCT). All participants will wear sensors on each ankle and wrist (total of 4 sensors) for one week at 4 different time points-1 week prior to discharge from inpatient rehabilitation, 3- and 7- weeks post-discharge and 3-months post-discharge. There will be a control group and an intervention group. Only participants randomized into the intervention group will receive Health and Activity Reports (HARs), feedback forms developed with input from physiotherapists in the the stroke program at GF Strong (via focus groups). The HARs will have detailed information regarding the participant's activity patterns (i.e., sedentary behavior, gait, and sleep), and will be used to inform their goal setting sessions with their Physiotherapist (PT). The last time point of collection (3 months post discharge) represents the post-intervention assessment, participants in the intervention group will not receive their activity reports until completing the close-out interviews. This interview will qualitatively assess the participants experiences with the sensors and the associated goal setting sessions. Controls will have the option to look at their HARs across all time points at the end of the study only.

Statistical Analysis: Transcripts from the focus group(s) with the physiotherapists will be qualitatively analyzed to generate the HAR's prior to its use with patients. Feasibility will be assessed using recruitment and retention rate, compliance rate, and number of technical and adverse events. Between intervention and control group differences will be investigated at 3 months post-discharge in use of stroke-affected upper extremity, walking and general activity levels, sedentary behaviour and sleep which will reveal the preliminary efficacy of this intervention. Lastly, transcripts from the close out interviews with the participants will be qualitatively analyzed to assess participant experiences with the sensors and associated goal setting sessions.

Conditions
Stroke
Being tested
Activity Counselling
Keywords
Wearable sensors, Stroke Rehabilitation, inertial measurement units, activity counselling
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activity CounsellingBehavioural

    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.

Study groups in NCT06119230
Study groupRoleWhat they receive
Sensors onlyNo interventionParticipants will only wear the sensors for a one week period during the 4 different time points.
Sensors and Activity CounsellingExperimentalParticipants 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.
Receives: Behavioral: Activity Counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    # of participants per month

    Measured: Baseline

  2. Sensor Wear Adherence

    Participant adherence to wearing sensors

    Measured: From enrolment to end of study

  3. Participant Adherence to Intervention

    # of activity counselling sessions attended by the participants

    Measured: From enrolment to end of study

  4. Acceptability of sensors for remote monitoring and intervention

    semi-structured interviews

    Measured: 3 months post-discharge

  5. Technical Issues/Events

    # of issues that occurs with the remote monitoring equipment

    Measured: From enrolment to end of study

  6. Adverse Events

    # of adverse events

    Measured: From enrolment to end of study

Secondary outcomes (4)
  1. Timed Up and Go (TUG) Test

    functional mobility

    Measured: Baseline and 3 months

  2. 10 Meter Walk Test

    Gait Speed

    Measured: Baseline and 3 months

  3. Action Research Arm Test (ARAT)

    Upper limb function

    Measured: Baseline and 3 months

  4. 6 Minute Walk Test

    functional exercise capacity

    Measured: Baseline and 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start1 Feb 2024
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06119230
Sponsor's protocol ID
H22-01979
Status last verified
Aug 2026
First submitted
17 May 2023
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Activity Counselling in people with Stroke, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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The Active Transition Home Post-Stroke Program | AzTrials