StrokeNCT07467785
Reaching the Unreached: Home-Based Telerehabilitation for Stroke Survivors
A study testing Telerehabilitation with Tenzr in people with Stroke, run by University of Alberta at 1 site in Canada.
Trial summary
After a stroke, many people have trouble using their arms and hands. This can make daily tasks-like eating, dressing, or writing-very hard. In Alberta, especially in small towns and rural areas, many stroke survivors go home from the hospital without being referred to rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Telerehabilitation with Tenzr
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not currently referred to, or participating in, upper extremity outpatient rehabilitation.
- A confirmed stroke diagnosis (ischemic or hemorrhagic)
- Have moderate-to-severe upper limb impairment
- Live at home
- Have access to internet and appropriate devices to have a virtual assessment with clinicians.
- ≥ 18 years of age
Who cannot join
- Referred to or currently participating in upper extremity outpatient rehabilitation.
- Severe cognitive, communication, or medical comorbidities that would preclude safe home-based exercise
- Don't have access to internet and appropriate devices to have a virtual assessment with clinicians.
- < 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD contact
Yoshino Okuma, BScRN, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Jessica M D'Amico, Scientific Program Lead, Assistant Professor, PhD, damico1@ualberta.ca
Yoshino Okuma, BScRN, MSc, yokuma@ualberta.ca
About this study
Official title: Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care
After a stroke, many people have trouble using their arms and hands. This can make daily tasks-like eating, dressing, or writing-very hard. In Alberta, especially in small towns and rural areas, many stroke survivors go home from the hospital without being referred to rehabilitation. As a result, they miss out on therapy that could help them get better.
This project will test a new way to bring rehabilitation directly into people's homes using telerehabilitation. We will work with 200 stroke survivors across Alberta who did not get regular outpatient rehab. Participants will use the clinically validated Tenzr system-a set of fun, game-like exercises with wearable sensors. Therapists will check in and guide them remotely.
Read more
When participants are enrolled in the study, they will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. Everyone in the study will be tested at the baseline, 8 weeks, and 16 weeks. At 16 weeks, we will also interview them to gather their feedback on the telerehabilitation. We want to learn if this program helps people improve arm and hand movement, if it's easy to use, and if people like it. We also want to see if it could be offered more widely across Alberta in the future.
The goal is to give more people access to stroke rehabilitation, no matter where they live.
- Conditions
- Stroke
- Being tested
- Standard of Care (SOC), Telerehabilitation with Tenzr
- Keywords
- rehabilitation, telerehabilitation, neurorecovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.
Telerehabilitation with TenzrOther
8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Group | Active comparator | The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline clinical assessments. Receives: Other: Standard of Care (SOC); Other: Telerehabilitation with Tenzr |
| Delayed Group | Active comparator | Delayed group will receive 8 weeks of observation (usual care) following the baseline clinical assessment; followed by 8 weeks of the same telerehabilitation intervention. Receives: Other: Standard of Care (SOC); Other: Telerehabilitation with Tenzr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. We will be obtaining and reporting the Upper Extremity subscore. It is a score without units.
Measured: Baseline, 8 weeks and 16 weeks.
Secondary outcomes (4)
Change in Nine-hole Peg Test (NHPT) (sec)
The NHPT requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
Measured: Baseline, 8 weeks, 16 weeks
Change in Box and Blocks Test (number of blocks)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.
Measured: Baseline, 8 weeks, 16 weeks
Change in Stroke Impact Scale Score
The Stroke Impact Scale (SIS) is a patient-reported outcome measure that evaluates the biopsychosocial aspects of life after stroke. No units.
Measured: Baseline, 8 weeks, 16 weeks
Change in PROMIS Upper Extremity Short Form
PROMIS® stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. PROMIS® tools measure what patients are able to do and how they feel by asking a number of questions. The PROMIS v1. 2 UE item bank is a useful clinical assessment tool with good psychometric properties that can be implemented in clinical settings and is focused on upper extremity items.
Measured: Baseline, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- This project will employ a randomized, delayed-start controlled crossover design within a hybrid Type I effectiveness-implementation trial framework. Two hundred individuals with post-stroke upper extremity impairment, who have not been referred to outpatient rehabilitation, will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. All participants will be assessed at baseline, 8 weeks, and 16 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Glenrose Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Jessica M D'Amico, PhD, Principal investigator, University of Alberta and Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467785
- Sponsor's protocol ID
- Pro00157166
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care
- ClinicalTrials.gov ID
- NCT07467785
- Acronym / sponsor ID
- Pro00157166
- Conditions
- Stroke
- Keywords
- rehabilitation, telerehabilitation, neurorecovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Glenrose Hospital Foundation
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After a stroke, many people have trouble using their arms and hands. This can make daily tasks-like eating, dressing, or writing-very hard. In Alberta, especially in small towns and rural areas, many stroke survivors go home from the hospital without being referred to rehabilitation. As a result, they miss out on therapy that could help them get better.
This project will test a new way to bring rehabilitation directly into people's homes using telerehabilitation. We will work with 200 stroke survivors across Alberta who did not get regular outpatient rehab. Participants will use the clinically validated Tenzr system-a set of fun, game-like exercises with wearable sensors. Therapists will check in and guide them remotely.
When participants are enrolled in the study, they will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. Everyone in the study will be tested at the baseline, 8 weeks, and 16 weeks. At 16 weeks, we will also interview them to gather their feedback on the telerehabilitation. We want to learn if this program helps people improve arm and hand movement, if it's easy to use, and if people like it. We also want to see if it could be offered more widely across Alberta in the future.
The goal is to give more people access to stroke rehabilitation, no matter where they live.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This project will employ a randomized, delayed-start controlled crossover design within a hybrid Type I effectiveness-implementation trial framework. Two hundred individuals with post-stroke upper extremity impairment, who have not been referred to outpatient rehabilitation, will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. All participants will be assessed at baseline, 8 weeks, and 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Active comparator | Other: Standard of Care (SOC), Other: Telerehabilitation with TenzrThe Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline clinical assessments. |
| Delayed Group | Active comparator | Other: Standard of Care (SOC), Other: Telerehabilitation with TenzrDelayed group will receive 8 weeks of observation (usual care) following the baseline clinical assessment; followed by 8 weeks of the same telerehabilitation intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Not currently referred to, or participating in, upper extremity outpatient rehabilitation.
- A confirmed stroke diagnosis (ischemic or hemorrhagic)
- Have moderate-to-severe upper limb impairment
- Live at home
- Have access to internet and appropriate devices to have a virtual assessment with clinicians.
Key exclusion criteria (4 listed)
- Referred to or currently participating in upper extremity outpatient rehabilitation.
- Severe cognitive, communication, or medical comorbidities that would preclude safe home-based exercise
- Don't have access to internet and appropriate devices to have a virtual assessment with clinicians.
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation. | Other | Delayed Group, Immediate Group |
| Telerehabilitation with Tenzr8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application. | Other | Delayed Group, Immediate Group |
Primary outcome
Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE)
Time frame: Baseline, 8 weeks and 16 weeks.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. We will be obtaining and reporting the Upper Extremity subscore. It is a score without units.
4 secondary outcomes
Change in Nine-hole Peg Test (NHPT) (sec)
Time frame: Baseline, 8 weeks, 16 weeks
Change in Box and Blocks Test (number of blocks)
Time frame: Baseline, 8 weeks, 16 weeks
Change in Stroke Impact Scale Score
Time frame: Baseline, 8 weeks, 16 weeks
Change in PROMIS Upper Extremity Short Form
Time frame: Baseline, 8 weeks, 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD contact
Yoshino Okuma, BScRN, MSc contact
Jessica M D'Amico, PhD principal investigator
University of Alberta and Alberta Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation with Tenzr in people with Stroke, run by University of Alberta 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 6 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: looking for participants now, as of the sponsor's last update on 3 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD (780-203-9478, damico1@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE) (time frame: Baseline, 8 weeks and 16 weeks.). 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 3 Jun 2026.