StrokemithesenmostNCT04030806

Mirror Therapy in Sensorimotor Recovery of Paretic Upper Extremity After Chronic Stroke

A study of Stroke, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Stroke
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteBrazil
Study dates: 3 Jul 2019to 31 Dec 2019
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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have suffered a single stroke, ischemic or hemorrhagic at least 6 months prior to the study and at most 5 years prior to the study, diagnosed by MRI and / or CT scan;
Age between 30 and 80 years;
Spasticity ≤ 3 in the flexor muscles of the elbow, wrist and fingers, shoulder horizontal adductor (Ashworth Modified Scale);
Mild or moderate sensorimotor impairment (Fugl-Meyer score scale - mild: 58-64 points, moderate: 39-57 points);
Present ability to understand the instructions of the study (Mini-Mental score ≥ 18 for schooled individuals and ≥ 13 for illiterate individuals);
Present muscular strength ≥ 3 in the flexor muscles of shoulder, and extensors of elbow and wrist.
Be able to stay in position for more than 30 minutes;

Who cannot join

Visual deficit that may limit participation in Mirror Therapy;
History of severe depression or severe psychiatric disorder;
Other neurological or musculoskeletal disorders in the upper limb not related to the stroke;
Severe visuospatial negligence.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Caren Luciane Bernardi
Porto Alegre, Rio Grande do Sul, 90620-160

Other trials in Brazil

About this study

Official title: Effect of Mirror Therapy in Sensorimotor Recovery of The Paretic Upper Extremity After Chronic Stroke: a Randomized Clinical Study

Stroke is characterized by poor brain perfusion resulting from an ischemic or hemorrhagic event, causing a sensorimotor disorder in the upper extremity (UE) contralateral to the lesion. Mirror Therapy (MT) has been used in rehabilitation and its effects are related to the activation of mirror neurons and cortical reorganization. However, few studies have investigated the isolated effect of MT on the rehabilitation of these individuals.

Objective: To investigate the isolated effect of MT on motor function, sensitivity, muscle strength, manual dexterity and spasticity of the paretic UE of individuals with chronic hemiparesis after stroke.

Design: Randomized simple-blind trial. Subject: Twenty-six patients post chronic, aged between 30 and 80 years, with mild or moderate sensorimotor impairment in UE will be evaluated.

Intervention: The subjects will be randomly distributed in: intervention group will perform 60 minutes of MT and the control group will perform 60 minutes of control therapy composed of the same exercises, but without the mirror. Both groups will hold two sessions per week for six weeks.

Main measure: Participants will be evaluated before and after the intervention. They will be evaluated through the Fugl-Meyer Scale to measure UL sensorimotor performance, Box-and-Block Test for manual dexterity, Dynamometry for palmar grip strength and Modified Ashworth Scale for spasticity. With this study, it was expected that the intervention group presented better results regarding the sensorimotor function when compared to the control group.

The data will be expressed as mean and 95% confidence interval (continuous variable) and absolute frequency (categorical variables). To compare the outcomes of the different experimental sessions and at the different moments (pre and post session), the Generalized Estimating Equations with post hoc LSD (Least Significant Difference) methods will be used. For all analysis the significance level was set at α = 0.05 and statistical software SPSS (Statistical Package for Social Sciences for Mac, version 22.0, IBM, USA) will be used.

Read the detailed description

Sample Size: The sampling was simple random and the calculation of the sample size needed to carry out this research was estimated using GPower software. The power and standard deviation were estimated from previous studies (Park et al., 2015) with a similar design. The sample size estimate for the present research project was 13 individuals per group (Mirror Therapy group and control group), totalizing 26 individuals, considering a level of significance (p) 5% and power of 80%.

Conditions: Stroke
Being tested: Mirror therapy intervention and control intervention
Keywords: stroke, mirror therapy, upper extremity
Medical subject headings: Stroke

What participants receive

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

Mirror therapy intervention and control interventionOther
The exercise protocol will be composed of bimanual activities, performed by both the hands of the patient (paretic and healthy). The same protocol will be applied for both groups (intervention group and control group).
Initially, the desensitization of the limbs will be accomplished by brushing the skin with objects of different textures (sponge, brush, cloths). Afterwards, isolated exercises of fingers (flexion-extension, opposition), wrists (flexo-extension), forearms (prono-supination) and elbows (flexo-extension) and functional exercises such as cleaning a table with a cloth, tightening sponges, roll balls. Each exercise will be performed slowly and repeated for 15 times, totaling three series of each exercise. The protocol used will be based on the proposal of Rothgangel and Braun (2013). The intervention will be carried out by the author of the project and by students of scientific initiation.

Study groups in NCT04030806
Study group	Role	What they receive
Intervention group	Experimental	All patients will perform 60 minutes of intervention, twice a week, for six weeks. During the intervention, the patient will be positioned seated in a chair with a table in front of him and a mirror (50cm x 50cm) will be placed vertically between his upper extremity. The patient's paretic upper extremity will be positioned behind the mirror, allowing only the movements of his healthy upper extremity to be visualized. The reflective side of the mirror will be facing the healthy upper extremity , the patient will perform the exercises observing the movements of his healthy upper extremity through the reflection produced by the mirror, interpreting as the movement of his paretic member. Receives: Other: Mirror therapy intervention and control intervention
Control group	Sham comparator	All patients will perform 60 minutes of intervention, twice a week, for six weeks. The mirror will be placed in the same position as the intervention group. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm. In the control group, the patients will be submitted to the same bimanual activities of the intervention group, but without the reflecting side of the mirror. Thus, the nonreflective side of the mirror will be facing the healthy arm, the patient will perform the same exercises visualizing only the movement of the healthy member. Receives: Other: Mirror therapy intervention and control intervention

What is being measured

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

Motor function of the paretic upper extremity
The Fugl-Meyer motor assessment scale - FMAS - upper extremity section will be applied to measure the motor function of the paretic limb. In the motor domain, the tendon reflexes, synergistic movements, coordination and velocity of the upper limb are evaluated. It also includes evaluation of wrist movements and five types of grip. It consists of a cumulative numerical scoring system that evaluates the motor function of the upper extremity. Each item has three possible scores: 0 (not performed); 1 (partially accomplished) and 2 (fully realized). The total score ranged from 0 to 66 points, with scores ranging from 58-64 reflect mild impairment, 39-57 moderate impairment, and values below 39 show severe impairment.
Measured: 20 minutes
Sensory function of the paretic upper extremity
The Fugl-Meyer Sensory Rating Scale - FMAS - upper extremity section will be applied to measure the sensory function of the paretic limb. Sensation is assessed as absent, deficient or normal for light touch and proprioception. This evaluation considered the shoulder, elbow, wrist and thumb. Each item has three possible scores: 0 (anesthesia); 1 (hypoesthesia or anesthesia) and 2 (normal). A total score ranged from 0 to 12 points, a higher score indicate a better sensory function.
Measured: 15 minutes

Secondary outcomes (6)

Manual dexterity
Box and Block Test (BBT) - Functional upper limb test - will be applied to evaluate the gross dexterity manual. The test consists of moving, one by one, the largest possible number of blocks from one box to the other of the same size. The recorded score will be equivalent to the number of blocks moved from side to side in 60 seconds.
Measured: 10 minutes
Palmar grip strength
Upper limb dynamometry will be applied to assess muscular strength of the upper limb paresis through palmar grip strength. For measurement, The Jamar® Manual Dynamometer (Sammons Preston Rolyan), in which the individual should remain seated in a chair without arm support, with shoulder attached, neutral rotation, elbow flexed at 90°, forearm in neutral position and extension wrist (between 0 and 30º). Three repetitions of the test will be performed, with a minimum interval of 20 seconds between each measurement, the final value being the arithmetic mean of the three measurements. All subjects will be instructed verbally to produce maximum force.
Measured: 10 minutes
Spasticity of paretic upper extremity
The Modified Ashworth Scale (MAS) will be used to assess spasticity, evaluating the resistance to passive movement. It consists of 0-4 point scale that assesses resistance to passive movement, in which higher scores corresponding to spasticity or increase in tone, while lower scores indicate normal muscle tone. The patients stayed in a sitting position to the assessment of the muscle tone of the elbow flexors, wrist flexors and horizontal shoulder adductor of the paretic UE, with three mobilizations for each muscle group.
Measured: 10 minutes
Pain of paretic upper extremity
The Visual Analogue Scale (VAS) for pain will be used to evaluate the pain present in the paretic member. It is a one-dimensional instrument for the assessment of pain intensity. It is a line with the numbers numbered 0-10. At one end of the line is marked "score 0 = no pain" and the other "score 10 = worst pain imaginable". The patient is then asked to evaluate and mark the pain present at that time.
Measured: 2 minutes
Level of functional disability
The level of functional disability will be assessed using the Functional Independence Measure Scale (MIF). MIF measures physical and cognitive dysfunction and care needs, and consists of 18 items. These items are grouped in 6 subscales that measure self-care, sphincter control, transfers, locomotion, communication and social cognition. Changes in the performance of activities are measured objectively by observing performance. Each item is evaluated with a 7-point scale that specifies the amount of help needed (1 = complete dependence, 7 = complete independence). So the total score ranges from 18 to 126, the highest score indicates better independence.
Measured: 15 minutes
Quality of life after stroke: The Stroke Impact Scale 3.0
The Stroke Impact Scale 3.0 (SIS 3.0) is a 59-item self-report assessment of stroke outcome used to assess patients' quality of life. The SIS has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better quality of life.
Measured: 15 minutes

Timeline

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

3 Jul 201931 Dec 2019

First posted24 Jul 2019
Study start3 Jul 2019
Primary completion30 Nov 2019 (estimated)
Study completion31 Dec 2019 (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.
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: 26 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04030806
Sponsor's protocol ID: CBernardi
Acronym: mithesenmost
Status last verified: Jul 2019
First submitted: 2 Jul 2019
Last updated: 25 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Mirror Therapy in Sensorimotor Recovery of The Paretic Upper Extremity After Chronic Stroke: a Randomized Clinical Study
ClinicalTrials.gov ID: NCT04030806
Acronym / sponsor ID: mithesenmost / CBernardi
Conditions: Stroke
Keywords: stroke, mirror therapy, upper extremity
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 26 participants (estimated)
Lead sponsor: Federal University of Health Science of Porto AlegreUniversity, hospital or other
Study start: 3 Jul 2019 (actual)
Primary completion: 30 Nov 2019 (estimated)
Study completion: 31 Dec 2019 (estimated)
First posted: 24 Jul 2019 (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.

Design: Randomized simple-blind trial. Subject: Twenty-six patients post chronic, aged between 30 and 80 years, with mild or moderate sensorimotor impairment in UE will be evaluated.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Other: Mirror therapy intervention and control interventionAll patients will perform 60 minutes of intervention, twice a week, for six weeks. During the intervention, the patient will be positioned seated in a chair with a table in front of him and a mirror (50cm x 50cm) will be placed vertically between his upper extremity. The patient's paretic upper extremity will be positioned behind the mirror, allowing only the movements of his healthy upper extremity to be visualized. The reflective side of the mirror will be facing the healthy upper extremity , the patient will perform the exercises observing the movements of his healthy upper extremity through the reflection produced by the mirror, interpreting as the movement of his paretic member.
Control group	Sham comparator	Other: Mirror therapy intervention and control interventionAll patients will perform 60 minutes of intervention, twice a week, for six weeks. The mirror will be placed in the same position as the intervention group. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm. In the control group, the patients will be submitted to the same bimanual activities of the intervention group, but without the reflecting side of the mirror. Thus, the nonreflective side of the mirror will be facing the healthy arm, the patient will perform the same exercises visualizing only the movement of the healthy member.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have suffered a single stroke, ischemic or hemorrhagic at least 6 months prior to the study and at most 5 years prior to the study, diagnosed by MRI and / or CT scan;
Age between 30 and 80 years;
Spasticity ≤ 3 in the flexor muscles of the elbow, wrist and fingers, shoulder horizontal adductor (Ashworth Modified Scale);
Mild or moderate sensorimotor impairment (Fugl-Meyer score scale - mild: 58-64 points, moderate: 39-57 points);
Present ability to understand the instructions of the study (Mini-Mental score ≥ 18 for schooled individuals and ≥ 13 for illiterate individuals);

Key exclusion criteria (4 listed)

Visual deficit that may limit participation in Mirror Therapy;
History of severe depression or severe psychiatric disorder;
Other neurological or musculoskeletal disorders in the upper limb not related to the stroke;
Severe visuospatial negligence.

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 therapy intervention and control interventionThe exercise protocol will be composed of bimanual activities, performed by both the hands of the patient (paretic and healthy). The same protocol will be applied for both groups (intervention group and control group). Initially, the desensitization of the limbs will be accomplished by brushing the skin with objects of different textures (sponge, brush, cloths). Afterwards, isolated exercises of fingers (flexion-extension, opposition), wrists (flexo-extension), forearms (prono-supination) and elbows (flexo-extension) and functional exercises such as cleaning a table with a cloth, tightening sponges, roll balls. Each exercise will be performed slowly and repeated for 15 times, totaling three series of each exercise. The protocol used will be based on the proposal of Rothgangel and Braun (2013). The intervention will be carried out by the author of the project and by students of scientific initiation.	Other	Control group, Intervention group

Primary outcome

Motor function of the paretic upper extremity
Time frame: 20 minutes
The Fugl-Meyer motor assessment scale - FMAS - upper extremity section will be applied to measure the motor function of the paretic limb. In the motor domain, the tendon reflexes, synergistic movements, coordination and velocity of the upper limb are evaluated. It also includes evaluation of wrist movements and five types of grip. It consists of a cumulative numerical scoring system that evaluates the motor function of the upper extremity. Each item has three possible scores: 0 (not performed); 1 (partially accomplished) and 2 (fully realized). The total score ranged from 0 to 66 points, with scores ranging from 58-64 reflect mild impairment, 39-57 moderate impairment, and values below 39 show severe impairment.
Sensory function of the paretic upper extremity
Time frame: 15 minutes
The Fugl-Meyer Sensory Rating Scale - FMAS - upper extremity section will be applied to measure the sensory function of the paretic limb. Sensation is assessed as absent, deficient or normal for light touch and proprioception. This evaluation considered the shoulder, elbow, wrist and thumb. Each item has three possible scores: 0 (anesthesia); 1 (hypoesthesia or anesthesia) and 2 (normal). A total score ranged from 0 to 12 points, a higher score indicate a better sensory function.

6 secondary outcomes

Manual dexterity
Time frame: 10 minutes
Palmar grip strength
Time frame: 10 minutes
Spasticity of paretic upper extremity
Time frame: 10 minutes
Pain of paretic upper extremity
Time frame: 2 minutes
Level of functional disability
Time frame: 15 minutes
Quality of life after stroke: The Stroke Impact Scale 3.0
Time frame: 15 minutes

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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.

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 of Stroke, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

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 7 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?

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?

Motor function of the paretic upper extremity (time frame: 20 minutes). 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 NCT04030806.

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 25 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.