StrokeNCT03175237
Mirror Therapy in Pos Stroke Individuals
A study testing Mirror Therapy in people with Stroke, run by Universidade Federal do Rio Grande do Norte.
Trial summary
To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 27 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2014to 30 Sep 2015
- 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
- Inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the Mini Mental State Examination (MMSE) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the Berg Balance Scale (BBS)
Who cannot join
- Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded
About this study
Official title: Mirror Therapy: Technique Benefits in Different Motor Impairment in Post-stroke Subjects
To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation Inventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.
Read the detailed description
Objective: To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. Methods: This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (IntrinsicMotivationInventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.
- Conditions
- Stroke
- Being tested
- Mirror 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
| Study group | Role | What they receive |
|---|---|---|
| Group of Motor Patterns | Experimental | For the mirror therapy protocol applied to the Motor Standard, each patient was treated with 15 mirror therapy sessions, 3 times a week for a total duration of 50 minutes. There were 4 exercises of voluntary range of motion involving the extension and mass flexion of the fingers, adduction and abduction of the fingers, pronation and supination of the forearm and elbow extension with associated shoulder elevation. Receives: Other: Mirror Therapy |
| Group of Functional Activities | Experimental | For the mirror therapy protocol applied to functional activities, four functional exercises were performed: fitting of pieces stimulating fine and thick gripping, stacking of cubes / cups and transfer of objects of different shapes and sizes. Each patient was treated with 15 mirror therapy sessions, 3 times a week with a total duration of 50 minutes Receives: Other: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Scale
Sensory and motor Impairment in post-stroke subjects. Severity of motor damage. In this case, use only upper limb session (score 66)
Measured: baseline, 8 weeks and 3 months (follow-up)
Secondary outcomes (4)
Mini-mental state examination
brief assessment of cognition
Measured: baseline
Berg Balance Scale
Assessment of the static, dynamic and anticipatory balance
Measured: baseline
Intrinsic Motivation Inventory
self-report measure of intrinsic motivation
Measured: baseline, 7 days and 14 days
Functional Independence of measure
Assessment of activities of daily living and social cognition
Measured: baseline, 8 weeks and 3 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start10 May 2014
- Primary completion15 Aug 2015
- Study completion30 Sep 2015
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta de Oliveira Cacho, Universidade Federal do Rio Grande do Norte
- Investigators
- Roberta O Cacho, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175237
- Sponsor's protocol ID
- 262.686
- Status last verified
- Aug 2017
- First submitted
- 20 May 2017
- Last updated
- 8 Aug 2017
- 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 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy: Technique Benefits in Different Motor Impairment in Post-stroke Subjects
- ClinicalTrials.gov ID
- NCT03175237
- Acronym / sponsor ID
- 262.686
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 10 May 2014 (actual)
- Primary completion
- 15 Aug 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 5 Jun 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.
To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation Inventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.
Detailed description
Objective: To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. Methods: This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (IntrinsicMotivationInventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Motor Patterns | Experimental | Other: Mirror TherapyFor the mirror therapy protocol applied to the Motor Standard, each patient was treated with 15 mirror therapy sessions, 3 times a week for a total duration of 50 minutes. There were 4 exercises of voluntary range of motion involving the extension and mass flexion of the fingers, adduction and abduction of the fingers, pronation and supination of the forearm and elbow extension with associated shoulder elevation. |
| Group of Functional Activities | Experimental | Other: Mirror TherapyFor the mirror therapy protocol applied to functional activities, four functional exercises were performed: fitting of pieces stimulating fine and thick gripping, stacking of cubes / cups and transfer of objects of different shapes and sizes. Each patient was treated with 15 mirror therapy sessions, 3 times a week with a total duration of 50 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the Mini Mental State Examination (MMSE) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the Berg Balance Scale (BBS)
Key exclusion criteria (1 listed)
- Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded
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 | Other | Group of Functional Activities, Group of Motor Patterns |
Primary outcome
Fugl-Meyer Assessment Scale
Time frame: baseline, 8 weeks and 3 months (follow-up)
Sensory and motor Impairment in post-stroke subjects. Severity of motor damage. In this case, use only upper limb session (score 66)
4 secondary outcomes
Mini-mental state examination
Time frame: baseline
Berg Balance Scale
Time frame: baseline
Intrinsic Motivation Inventory
Time frame: baseline, 7 days and 14 days
Functional Independence of measure
Time frame: baseline, 8 weeks and 3 months (follow-up)
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 8 Aug 2017.
- 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.
Roberta O Cacho, PhD principal investigator
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy in people with Stroke, run by Universidade Federal do Rio Grande do Norte.
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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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: baseline, 8 weeks and 3 months (follow-up)). 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 8 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.