Stroke SequelaeNCT03755063
Recovernow: Tablet-Based Speech Therapy For Post-Stroke Aphasia
A study testing Speech therapy apps in people with Stroke Sequelae, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Speech therapy apps
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Nov 2019to 11 Apr 2022
- 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
- diagnosis of ischemic/hemorrhagic stroke documented with CT and/or MRI and,
- mild to moderate aphasia, and/or -) Scoring ≥ 1 on the Best Language parameters of the National Institute of Health Stroke Score (NIHSS).
Who cannot join
- Pre-existing speech, language or cognitive disorders (such as dementia, mild cognitive impairment),
- severe debilitating disease(s) that, in the opinion of the investigator, would preclude them from being able to complete the study to follow-up (ex: end-stage malignancy, ALS),
- Severe comprehension deficits (unable to follow simple one-step commands and/or unable to respond to yes/no questions reliably), and
- English is not the primary language
- subarachnoid, subdural and epidural hemorrhages.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
University Health Network / University of Toronto
Toronto, Ontario, M5G 2C4
About this study
Official title: Recovernow: A Multicentre Phase II Randomized Controlled Trial Of Early Mobile Tablet-Based Speech Therapy For Acute Stroke Patients With Aphasia
RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Primary outcome is improvement in the Western Aphasia Battery Aphasia (WAB-R)
Overall Study Aim: The primary study aim is to determine the futility and potential efficacy of mobile tablet-based speech therapy for post stroke aphasia.
Read more
Primary Endpoint: The primary outcome measure is change in the Aphasia quotient (AQ) from the WAB-R at 90 days. The WAB-R is a standardized aphasia battery. The AQ is calculated from four language sub-tests measuring spontaneous speech, word comprehension, repetition, and word finding.)
Secondary Endpoints: The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained.
Population: 226 participants will be enrolled over 3 years. Males and females, >18 years of age, with diagnosis of acute ischemic/hemorrhagic stroke confirmed by routine head computerized tomography (CT) scan with mild to moderate aphasia.
Phase: II
Number of Sites: It is anticipated that this will be a multi-center study, with the following facilities participating: The Ottawa Hospital, Ottawa, ON, Foothills Medical Centre, Calgary, Alberta and Toronto Western Hospital.
Protocol Therapy: Patients will be randomized 1:1 to receive either tablets with speech therapy apps (intervention group) or standard of care.
Study Duration: It is estimated that recruitment will take place over 3 years in the three participating centers.
Subject Participation Duration: All patients will be assessed clinically at baseline and Day 90 (+/-10).
Read the detailed description
Post-stroke aphasia is a major cause of disability. Aphasia is a heterogeneous condition and can manifest in a variety of communication impairments, including difficulty producing words or sentences and understanding spoken and/or written language. Compared to stroke patients without aphasia, patients with aphasia have longer hospital stays, more severe disability, greater nursing care dependency, are at a greater risk for depression, are discharged to long-term care more frequently, and are less likely to return to work, even when younger. When compared to non-aphasic patients with similar physical abilities, well-being and social supports, patients with aphasia engage in fewer instrumental activities of daily living (iADL) and report worse quality of life.
Investigators launched the RecoverNow research program in 2014 in an attempt to address the delays to access stroke rehabilitation from acute care centres. Our concept was to use mobile tablets to "bring rehab to the patient", and leverage the significant downtime experienced by stroke survivors in acute care. A pilot feasibility study using iPads to deliver speech therapy in the acute setting was started. In this study, our speech language pathologist (SLP) personalized the iPads by selecting commercially available speech therapy applications that specifically targeted the individual patients' deficits. Patients admitted to our stroke center underwent standard of care SLP assessments, and were then offered an iPad with instructions to work with the selected apps for a minimum of 1-hour a day. 30 patients in 6 months were enrolled, and demonstrated a recruitment rate of 68%, a retention rate of 97%, and an 83% adherence rate to a prescribed 1hour/day therapy regimen. Patients began using the tablet at a mean 6.8 days after stroke onset, for an average of 149.8 minutes/day throughout their inpatient stay. It was determined feasible to deliver speech therapy in the acute care setting using mobile tablets.
Based on these preliminary studies, the research group worked with the Ottawa Hospital Mobile Health Lab (mHealth) to refine the RecoverNow platform and develop a secure customizable Android operating system-based tablet. Briefly, this new platform is designed to be used by patients with post-stroke aphasia, meets all security requirements of health-care institutions, allows remote interaction between patients and SLPs, and allows patients to take the device with them as they transition from acute care to rehabilitation, home, or alternate levels of care.
In summary, it was shown that it is feasible to deliver speech therapy in the acute care setting using mobile tablets. The therapeutic intervention based on our experiences, the existing literature, and patient preferences was refined. The next step is to test the efficacy and cost-effectiveness of tablet-based speech therapy that begins in the acute care setting. It is proposed to begin with a pilot futility design, given the limited funding envelope for a clinical trial.
Using a novel futility design, this investigation will be Phase II clinical trial to test the potential efficacy of mobile tablet-based speech therapy for post stroke aphasia. Secondary objectives include a preliminary cost-effectiveness analysis and a capturing a variety of outcomes relevant to stroke recover to inform future studies and identify new opportunities for tablet-based therapy.
- Conditions
- Stroke Sequelae
- Being tested
- Speech therapy apps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech therapy appsOther
Speech therapy apps loaded on tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Tablet with speech therapy apps Receives: Other: Speech therapy apps |
| Standard of Care | No intervention | The standard care provided by speech language therapists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Aphasia Battery (WAB-R) scores
Is a diagnostic tool used to assess the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia and identifies the location of the lesion causing aphasia.This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild
Measured: 3 years
Secondary outcomes (1)
Cost-effectiveness
The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start13 Nov 2019
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Why it stopped: Delays and barriers secondary to covid.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dar Dowlatshahi, MD PhD, Principal investigator, Scientific Investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755063
- Sponsor's protocol ID
- 20180252-01H
- Status last verified
- Apr 2022
- First submitted
- 30 Oct 2018
- Last updated
- 19 Apr 2022
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovernow: A Multicentre Phase II Randomized Controlled Trial Of Early Mobile Tablet-Based Speech Therapy For Acute Stroke Patients With Aphasia
- ClinicalTrials.gov ID
- NCT03755063
- Acronym / sponsor ID
- 20180252-01H
- Conditions
- Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays and barriers secondary to covid.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 27 Nov 2018 (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.
RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Primary outcome is improvement in the Western Aphasia Battery Aphasia (WAB-R)
Overall Study Aim: The primary study aim is to determine the futility and potential efficacy of mobile tablet-based speech therapy for post stroke aphasia.
Primary Endpoint: The primary outcome measure is change in the Aphasia quotient (AQ) from the WAB-R at 90 days. The WAB-R is a standardized aphasia battery. The AQ is calculated from four language sub-tests measuring spontaneous speech, word comprehension, repetition, and word finding.)
Secondary Endpoints: The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained.
Population: 226 participants will be enrolled over 3 years. Males and females, >18 years of age, with diagnosis of acute ischemic/hemorrhagic stroke confirmed by routine head computerized tomography (CT) scan with mild to moderate aphasia.
Phase: II
Number of Sites: It is anticipated that this will be a multi-center study, with the following facilities participating: The Ottawa Hospital, Ottawa, ON, Foothills Medical Centre, Calgary, Alberta and Toronto Western Hospital.
Protocol Therapy: Patients will be randomized 1:1 to receive either tablets with speech therapy apps (intervention group) or standard of care.
Study Duration: It is estimated that recruitment will take place over 3 years in the three participating centers.
Subject Participation Duration: All patients will be assessed clinically at baseline and Day 90 (+/-10).
Detailed description
Post-stroke aphasia is a major cause of disability. Aphasia is a heterogeneous condition and can manifest in a variety of communication impairments, including difficulty producing words or sentences and understanding spoken and/or written language. Compared to stroke patients without aphasia, patients with aphasia have longer hospital stays, more severe disability, greater nursing care dependency, are at a greater risk for depression, are discharged to long-term care more frequently, and are less likely to return to work, even when younger. When compared to non-aphasic patients with similar physical abilities, well-being and social supports, patients with aphasia engage in fewer instrumental activities of daily living (iADL) and report worse quality of life.
Investigators launched the RecoverNow research program in 2014 in an attempt to address the delays to access stroke rehabilitation from acute care centres. Our concept was to use mobile tablets to "bring rehab to the patient", and leverage the significant downtime experienced by stroke survivors in acute care. A pilot feasibility study using iPads to deliver speech therapy in the acute setting was started. In this study, our speech language pathologist (SLP) personalized the iPads by selecting commercially available speech therapy applications that specifically targeted the individual patients' deficits. Patients admitted to our stroke center underwent standard of care SLP assessments, and were then offered an iPad with instructions to work with the selected apps for a minimum of 1-hour a day. 30 patients in 6 months were enrolled, and demonstrated a recruitment rate of 68%, a retention rate of 97%, and an 83% adherence rate to a prescribed 1hour/day therapy regimen. Patients began using the tablet at a mean 6.8 days after stroke onset, for an average of 149.8 minutes/day throughout their inpatient stay. It was determined feasible to deliver speech therapy in the acute care setting using mobile tablets.
Based on these preliminary studies, the research group worked with the Ottawa Hospital Mobile Health Lab (mHealth) to refine the RecoverNow platform and develop a secure customizable Android operating system-based tablet. Briefly, this new platform is designed to be used by patients with post-stroke aphasia, meets all security requirements of health-care institutions, allows remote interaction between patients and SLPs, and allows patients to take the device with them as they transition from acute care to rehabilitation, home, or alternate levels of care.
In summary, it was shown that it is feasible to deliver speech therapy in the acute care setting using mobile tablets. The therapeutic intervention based on our experiences, the existing literature, and patient preferences was refined. The next step is to test the efficacy and cost-effectiveness of tablet-based speech therapy that begins in the acute care setting. It is proposed to begin with a pilot futility design, given the limited funding envelope for a clinical trial.
Using a novel futility design, this investigation will be Phase II clinical trial to test the potential efficacy of mobile tablet-based speech therapy for post stroke aphasia. Secondary objectives include a preliminary cost-effectiveness analysis and a capturing a variety of outcomes relevant to stroke recover to inform future studies and identify new opportunities for tablet-based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Other: Speech therapy appsTablet with speech therapy apps |
| Standard of Care | No intervention | –The standard care provided by speech language therapists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of ischemic/hemorrhagic stroke documented with CT and/or MRI and,
- mild to moderate aphasia, and/or -) Scoring ≥ 1 on the Best Language parameters of the National Institute of Health Stroke Score (NIHSS).
Key exclusion criteria (5 listed)
- Pre-existing speech, language or cognitive disorders (such as dementia, mild cognitive impairment),
- severe debilitating disease(s) that, in the opinion of the investigator, would preclude them from being able to complete the study to follow-up (ex: end-stage malignancy, ALS),
- Severe comprehension deficits (unable to follow simple one-step commands and/or unable to respond to yes/no questions reliably), and
- English is not the primary language
- subarachnoid, subdural and epidural hemorrhages.
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 |
|---|---|---|
| Speech therapy appsSpeech therapy apps loaded on tablets | Other | Treatment arm |
Primary outcome
Change in Western Aphasia Battery (WAB-R) scores
Time frame: 3 years
Is a diagnostic tool used to assess the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia and identifies the location of the lesion causing aphasia.This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild
1 secondary outcome
Cost-effectiveness
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Delays and barriers secondary to covid.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dar Dowlatshahi, MD PhD principal investigator
Scientific Investigator, OHRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech therapy apps in people with Stroke Sequelae, run by Ottawa Hospital Research Institute at 2 sites 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Delays and barriers secondary to covid.). Results are not available in the source record.
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?
Change in Western Aphasia Battery (WAB-R) scores (time frame: 3 years). 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 19 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.