StrokeNCT05312905
Mirror Therapy in Stroke
A study testing Mirror Therapy and Mirror Therapy + Cognitive Therapy in people with Stroke and Cognitive Therapy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation. The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Cognitive Therapy, Telerehabilitation
- What is being tested?
- Mirror Therapy and Mirror Therapy + Cognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2021to 7 Jan 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years old and over having had a stroke having unilateral involvement having sufficient communication skills to answer oral and written questions and following instructions 20< points in MMSE
Who cannot join
- a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Mirror Therapy and Cognitive Therapeutic Exercises After Stroke
Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation. The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and to compare these effects with mirror therapy alone.
- Conditions
- Stroke, Cognitive Therapy, Telerehabilitation
- Being tested
- Mirror Therapy, Mirror Therapy + Cognitive Therapy
- 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
Mirror Therapy applied alone
Mirror Therapy + Cognitive TherapyOther
Mirror Therapy supported with Cognitive Exercises
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy | Active comparator | Exercises including mirror therapy will be applied to the participants in the Mirror Therapy group. The mirror will be placed in such a way that the affected extremity of the patient could not be seen behind the mirror and the healthy extremity would be in front of his eyes, the patient will perform the exercises indicated by the physiotherapist with his intact extremity, looking into the mirror. The exercises will be performed in sessions lasting 60 minutes, 3 days a week, over 8 weeks. Receives: Other: Mirror Therapy |
| Mirror+Cognitive Therapy | Experimental | The participants in the Mirror+Cognitive Therapy will be given a cognitive task with the application of mirror therapy. Cognitive tasks with mirror therapy will be applied in sessions lasting 60 minutes, 3 days a week, over 8 weeks. Receives: Other: Mirror Therapy + Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
The Mini-Mental State Examination (MMSE) is a 30-point test. Higher values mean better performance.
Measured: changes after 8 weeks
Fugl-Meyer Upper Extremity Motor Assessment
The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The total possible scale score is 226. Higher scores mean better performance.
Measured: changes after 8 weeks
Secondary outcomes (4)
Stroke-Specific Quality of Life Scale
Specific Quality Of Life scale (SSQOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. The original test consists of 49 items encompassing 12 domains. Each item is ranked on a 5-point scale, with higher scores indicating better function.
Measured: changes after 8 weeks
Beck Depression Scale
The Beck Depression Scale is a 21-item self-report inventory designed to assess the presence and severity in depressive symptoms. Each item is rated on a 4-point Likert-type scale ranging from 0 to 3, based on the severity in the last two weeks. Higher scores indicating worse level of depression.
Measured: changes after 8 weeks
Barthel Activity of Daily Living Scale
The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Eight factors are rated to produce an overall score on a point scale of 0 to 100. Then, an assignment is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points, higher scores indicating better function.
Measured: changes after 8 weeks
Modified Ashworth Scale
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). The usage of this scale is easy; however, the results depend on the evaluator. Higher scores indicating sever spasticity.
Measured: changes after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start10 Jun 2021
- Primary completion20 Dec 2021
- Study completion7 Jan 2022
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 Istanbul Medipol University HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farzin Hajebrahimi, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312905
- Sponsor's protocol ID
- MirrorCog2021
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available on reasonable request from the Principle Investigator. The data are not publicly available due to ethical issues.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Mirror Therapy and Cognitive Therapeutic Exercises After Stroke
- ClinicalTrials.gov ID
- NCT05312905
- Acronym / sponsor ID
- MirrorCog2021
- Conditions
- Stroke, Cognitive Therapy, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation. The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and to compare these effects with mirror therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy | Active comparator | Other: Mirror TherapyExercises including mirror therapy will be applied to the participants in the Mirror Therapy group. The mirror will be placed in such a way that the affected extremity of the patient could not be seen behind the mirror and the healthy extremity would be in front of his eyes, the patient will perform the exercises indicated by the physiotherapist with his intact extremity, looking into the mirror. The exercises will be performed in sessions lasting 60 minutes, 3 days a week, over 8 weeks. |
| Mirror+Cognitive Therapy | Experimental | Other: Mirror Therapy + Cognitive TherapyThe participants in the Mirror+Cognitive Therapy will be given a cognitive task with the application of mirror therapy. Cognitive tasks with mirror therapy will be applied in sessions lasting 60 minutes, 3 days a week, over 8 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 40 years old and over having had a stroke having unilateral involvement having sufficient communication skills to answer oral and written questions and following instructions 20< points in MMSE
Key exclusion criteria (1 listed)
- a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions
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 TherapyMirror Therapy applied alone | Other | Mirror Therapy |
| Mirror Therapy + Cognitive TherapyMirror Therapy supported with Cognitive Exercises | Other | Mirror+Cognitive Therapy |
Primary outcome
Mini-Mental State Examination
Time frame: changes after 8 weeks
The Mini-Mental State Examination (MMSE) is a 30-point test. Higher values mean better performance.
Fugl-Meyer Upper Extremity Motor Assessment
Time frame: changes after 8 weeks
The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The total possible scale score is 226. Higher scores mean better performance.
4 secondary outcomes
Stroke-Specific Quality of Life Scale
Time frame: changes after 8 weeks
Beck Depression Scale
Time frame: changes after 8 weeks
Barthel Activity of Daily Living Scale
Time frame: changes after 8 weeks
Modified Ashworth Scale
Time frame: changes after 8 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 14 Apr 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study will be available on reasonable request from the Principle Investigator. The data are not publicly available due to ethical issues.
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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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 Mirror Therapy + Cognitive Therapy in people with Stroke and Cognitive Therapy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 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 1 site in Turkey (Türkiye). 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?
Mini-Mental State Examination (time frame: changes after 8 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?
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 14 Apr 2022.