StrokeNCT03371290
Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke
A study testing Mirror Therapy in people with Stroke, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Objective: To investigate the acute effect of mirror therapy (MT) on motor control, manual dexterity and spasticity of the paretic upper extremity (UE) of individuals with chronic hemiparesis after stroke, during reaching task. Design: Randomized cross-over single-blinded trial. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Sep 2017to 30 Dec 2017
- 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
None listed.
Who cannot join
- Patients with visual impairment; history of severe depression or severe psychiatric disorder; other neurological or musculoskeletal disorders in the UE; visuospatial heminegligence; or pain file ≥ 4 on the compromised UE (Visual Analog Pain Scale), were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Acute Effect of Mirror Therapy on Motor Control, Manual Dexterity and Spasticity of Paretic Upper Extremity After Chronic Stroke
Objective: To investigate the acute effect of mirror therapy (MT) on motor control, manual dexterity and spasticity of the paretic upper extremity (UE) of individuals with chronic hemiparesis after stroke, during reaching task.
Design: Randomized cross-over single-blinded trial. Subjects: Thirty-three patients post chronic stroke were recruited of the study.
Read more
Intervention: Patients who first participated in the MT intervention performed a single session of MT, whereas in the control intervention a single session composed of the same exercises was performed, but without the mirror. After a month washout, the patients switched groups.
Main measure: The primary outcome measure was motor control. The secondary outcome measure was manual dexterity and UE spasticity.
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.
Key words: Stroke, mirror therapy, upper extremity, kinematic analysis
- Conditions
- Stroke
- Being tested
- Mirror Therapy, Control Intervention
- 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
The healthy UE will be positioned in front of the mirror and the paretic UE behind it, enabling the patient to observe the movements of the healthy limb through the mirror, interpreting that image as the affected limb. The MT protocol will be composed of active bimanual exercises of range of motion and functional exercises. Three sets of 15 repetitions will be performed for each exercise with a 20 seconds interval between each series, for 30 minutes. The exercises: 1) Elbow flexion/extension; 2) Wrist flexion/extension in neutral position; 3) Fingers flexion/extension in neutral position; 4) Forearm pronation/supination; 5) Roll the ball with hands; 6) Squeezing the sponge; 7) Drag a towel in anteroposterior direction; 8) Opponency of fingers; 9) Climb the mirror with the fingers (similar to walking the spider).
Control InterventionOther
In the control intervention, patients will be performed the same bimanual activities proposed by the MT protocol, but without the reflector side of the mirror. The mirror will be placed in the same position as the MT intervention. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm.
Both interventions will be performed a single session of MT or control composed of 30 minutes of exercises. The participants who will be first assigned to the MT intervention, after 4-weeks washout period, will be performed the same procedures, but in the control intervention. Likewise, patients who will be first allocated to control intervention, after 4-weeks of washout, will be performed the same procedures, however in MT intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy Intervention | Experimental | Not described Receives: Other: Mirror Therapy |
| Control Intervention | Active comparator | Not described Receives: Other: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Movement Cycle Time (MCT)
The time to perform the cycle of movement in seconds, which includes the going and return phase of the arm to the table
Measured: changes from baseline at 30 minutes after each session
Change Index of Curvature (IC)
representative of the movement straightness during the going phase, an IC equal to 1 indicates a perfectly rectilinear motion
Measured: changes from baseline at 30 minutes after each session
Change Average Jerk (AJ)
measure of the movement smoothness, this index decreases with increased smoothness
Measured: changes from baseline at 30 minutes after each session
Change Mean Movement Velocity (MMV)
fingernail marker mean velocity during the going phase, an increased MMV indicates an improves task performance
Measured: changes from baseline at 30 minutes after each session
Change Adjusting Sway (AS)
measure of the adjustments made to reach the target, decreases as the movement precision increases
Measured: changes from baseline at 30 minutes after each session
Change Range of motion
Range of motion of shoulder (flexion/extension, abduction/adduction) and elbow (flexion/extension).
Measured: changes from baseline at 30 minutes after each session
Secondary outcomes (2)
Change Manual dexterity
Box and Block Test (BBT) was used to assess the gross manual dexterity. The test consists in moving, one by one, the largest possible number of blocks from one box compartment to the other, first with the uncommitted UE and then with the paretic UE. The recorded score is equivalent to the number of blocks moved from one side of the box to the other in 60 seconds
Measured: changes from baseline at 30 minutes after each session
Change Spasticity of paretic upper extremity
The Modified Ashworth Scale (MAS) was used to assess spasticity, evaluating the resistance to passive movement. 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. Higher scores correspond to spasticity or increase in tone, while lower scores indicate normal muscle tone.
Measured: changes from baseline at 30 minutes after each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start27 Sep 2017
- Primary completion28 Sep 2017
- Study completion30 Dec 2017 (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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caren Luciane Bernardi, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371290
- Sponsor's protocol ID
- CEP UFCSPA 90050-170
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Mirror Therapy on Motor Control, Manual Dexterity and Spasticity of Paretic Upper Extremity After Chronic Stroke
- ClinicalTrials.gov ID
- NCT03371290
- Acronym / sponsor ID
- CEP UFCSPA 90050-170
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 13 Dec 2017 (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.
Objective: To investigate the acute effect of mirror therapy (MT) on motor control, manual dexterity and spasticity of the paretic upper extremity (UE) of individuals with chronic hemiparesis after stroke, during reaching task.
Design: Randomized cross-over single-blinded trial. Subjects: Thirty-three patients post chronic stroke were recruited of the study.
Intervention: Patients who first participated in the MT intervention performed a single session of MT, whereas in the control intervention a single session composed of the same exercises was performed, but without the mirror. After a month washout, the patients switched groups.
Main measure: The primary outcome measure was motor control. The secondary outcome measure was manual dexterity and UE spasticity.
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.
Key words: Stroke, mirror therapy, upper extremity, kinematic analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy Intervention | Experimental | Other: Mirror Therapy |
| Control Intervention | Active comparator | Other: Control Intervention |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with visual impairment; history of severe depression or severe psychiatric disorder; other neurological or musculoskeletal disorders in the UE; visuospatial heminegligence; or pain file ≥ 4 on the compromised UE (Visual Analog Pain Scale), were excluded from the study.
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 TherapyThe healthy UE will be positioned in front of the mirror and the paretic UE behind it, enabling the patient to observe the movements of the healthy limb through the mirror, interpreting that image as the affected limb. The MT protocol will be composed of active bimanual exercises of range of motion and functional exercises. Three sets of 15 repetitions will be performed for each exercise with a 20 seconds interval between each series, for 30 minutes. The exercises: 1) Elbow flexion/extension; 2) Wrist flexion/extension in neutral position; 3) Fingers flexion/extension in neutral position; 4) Forearm pronation/supination; 5) Roll the ball with hands; 6) Squeezing the sponge; 7) Drag a towel in anteroposterior direction; 8) Opponency of fingers; 9) Climb the mirror with the fingers (similar to walking the spider). | Other | Mirror Therapy Intervention |
| Control InterventionIn the control intervention, patients will be performed the same bimanual activities proposed by the MT protocol, but without the reflector side of the mirror. The mirror will be placed in the same position as the MT intervention. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm. Both interventions will be performed a single session of MT or control composed of 30 minutes of exercises. The participants who will be first assigned to the MT intervention, after 4-weeks washout period, will be performed the same procedures, but in the control intervention. Likewise, patients who will be first allocated to control intervention, after 4-weeks of washout, will be performed the same procedures, however in MT intervention. | Other | Control Intervention |
Primary outcome
Change Movement Cycle Time (MCT)
Time frame: changes from baseline at 30 minutes after each session
The time to perform the cycle of movement in seconds, which includes the going and return phase of the arm to the table
Change Index of Curvature (IC)
Time frame: changes from baseline at 30 minutes after each session
representative of the movement straightness during the going phase, an IC equal to 1 indicates a perfectly rectilinear motion
Change Average Jerk (AJ)
Time frame: changes from baseline at 30 minutes after each session
measure of the movement smoothness, this index decreases with increased smoothness
Change Mean Movement Velocity (MMV)
Time frame: changes from baseline at 30 minutes after each session
fingernail marker mean velocity during the going phase, an increased MMV indicates an improves task performance
Change Adjusting Sway (AS)
Time frame: changes from baseline at 30 minutes after each session
measure of the adjustments made to reach the target, decreases as the movement precision increases
Change Range of motion
Time frame: changes from baseline at 30 minutes after each session
Range of motion of shoulder (flexion/extension, abduction/adduction) and elbow (flexion/extension).
2 secondary outcomes
Change Manual dexterity
Time frame: changes from baseline at 30 minutes after each session
Change Spasticity of paretic upper extremity
Time frame: changes from baseline at 30 minutes after each session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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. 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 in people with 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 0 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: status not confirmed, as of the sponsor's last update on 13 Dec 2017. 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. 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?
Change Movement Cycle Time (MCT) (time frame: changes from baseline at 30 minutes after each session). The study lists 6 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 13 Dec 2017.