Stroke, AcuteNCT04542772
Mirror Therapy Education for Acute Stroke Patients
A study testing Mirror Therapy and Regular Rehabilitation in people with Stroke, Acute, run by Health Sciences North Research Institute at 1 site in Canada.
Trial summary
In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Mirror Therapy and Regular Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2022to 3 May 2024
- 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
- Admitted with diagnosis of stroke with onset within two weeks
- Medically stable
- Able to follow directions
- No severe cognitive impairments that could interfere with patient participation
- Consent to treatment by patient
- Alpha-Functional Independence Measure (Alpha-FIM) score of > 40
Who cannot join
- Medical instability
- Lack of motivation
- Recurrent/ chronic stroke
- Recent upper extremity musculoskeletal injuries with movement restrictions
- Receptive or global aphasia
- Delirium
- Unilateral neglect
- Visual field deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Patient Education on Mirror Therapy to Improve Upper Extremity Function in Acute Stroke Patients
In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?
- Conditions
- Stroke, Acute
- Being tested
- Mirror Therapy, Regular Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
Participants will receive the standard-of-care; multidisciplinary rehabilitation intervention based on their needs and tolerance, and will receive an additional 30 min of Mirror Therapy education. During Mirror Therapy education, the patients will be educated or shown how to perform MT and the patients will complete the recommended exercises on their own for 30 minutes/day for 5 days a week/ for 4 weeks. Standard Mirror Therapy Protocol will be followed.
Regular RehabilitationOther
Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy + Standard of Care | Experimental | Participants in this group will receive standard of care based on their needs along with mirror therapy education. Receives: Other: Mirror Therapy; Other: Regular Rehabilitation |
| Standard of Care | Active comparator | Participants in this group will receive only standard of care based on their needs. Receives: Other: Regular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment scale
Scores of < 31 corresponded with 'no to poor' upper extremity capacity, 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.
Measured: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.
Wolf Motor Function Test
Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels.
Measured: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
Secondary outcomes (1)
Modified Barthel Index
Assess Activity of Daily Living, Scores of <15 usually represents moderate disability and <10 usually represents severe disability.
Measured: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start4 Jul 2022
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Sciences North Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542772
- Sponsor's protocol ID
- C-20-15
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rajendran V, Jeevanantham D, Lariviere C, Singh RJ, Zeman L, Papuri P. Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol. Trials. 2021 Jul 9;22(1):439. doi: 10.1186/s13063-021-05380-9.
PubMed 34243808
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Patient Education on Mirror Therapy to Improve Upper Extremity Function in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT04542772
- Acronym / sponsor ID
- C-20-15
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Health Sciences North Research InstituteUniversity, hospital or other
- Collaborators
- NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 9 Sep 2020 (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.
In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy + Standard of Care | Experimental | Other: Mirror Therapy, Other: Regular RehabilitationParticipants in this group will receive standard of care based on their needs along with mirror therapy education. |
| Standard of Care | Active comparator | Other: Regular RehabilitationParticipants in this group will receive only standard of care based on their needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted with diagnosis of stroke with onset within two weeks
- Medically stable
- Able to follow directions
- No severe cognitive impairments that could interfere with patient participation
- Consent to treatment by patient
Key exclusion criteria (8 listed)
- Medical instability
- Lack of motivation
- Recurrent/ chronic stroke
- Recent upper extremity musculoskeletal injuries with movement restrictions
- Receptive or global aphasia
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 |
|---|---|---|
| Mirror TherapyParticipants will receive the standard-of-care; multidisciplinary rehabilitation intervention based on their needs and tolerance, and will receive an additional 30 min of Mirror Therapy education. During Mirror Therapy education, the patients will be educated or shown how to perform MT and the patients will complete the recommended exercises on their own for 30 minutes/day for 5 days a week/ for 4 weeks. Standard Mirror Therapy Protocol will be followed. | Other | Mirror Therapy + Standard of Care |
| Regular RehabilitationParticipants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance. | Other | Mirror Therapy + Standard of Care, Standard of Care |
Primary outcome
Fugl-Meyer Assessment scale
Time frame: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.
Scores of < 31 corresponded with 'no to poor' upper extremity capacity, 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.
Wolf Motor Function Test
Time frame: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels.
1 secondary outcome
Modified Barthel Index
Time frame: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 34243808Rajendran V, Jeevanantham D, Lariviere C, Singh RJ, Zeman L, Papuri P. Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol. Trials. 2021 Jul 9;22(1):439. doi: 10.1186/s13063-021-05380-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Regular Rehabilitation in people with Stroke, Acute, run by Health Sciences North Research Institute 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 8 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 5 Oct 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?
Fugl-Meyer Assessment scale (time frame: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542772, which also lists 1 linked publication.
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 5 Oct 2026.