- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175237
Mirror Therapy in Pos Stroke Individuals
August 7, 2017 updated by: Roberta de Oliveira Cacho, Universidade Federal do Rio Grande do Norte
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group of Motor Patterns
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.
|
|
EXPERIMENTAL: Group of Functional Activities
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline, 8 weeks and 3 months (follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-mental state examination
Time Frame: baseline
|
brief assessment of cognition
|
baseline
|
Berg Balance Scale
Time Frame: baseline
|
Assessment of the static, dynamic and anticipatory balance
|
baseline
|
Intrinsic Motivation Inventory
Time Frame: baseline, 7 days and 14 days
|
self-report measure of intrinsic motivation
|
baseline, 7 days and 14 days
|
Functional Independence of measure
Time Frame: baseline, 8 weeks and 3 months (follow-up)
|
Assessment of activities of daily living and social cognition
|
baseline, 8 weeks and 3 months (follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 10, 2014
Primary Completion (ACTUAL)
August 15, 2015
Study Completion (ACTUAL)
September 30, 2015
Study Registration Dates
First Submitted
May 20, 2017
First Submitted That Met QC Criteria
May 31, 2017
First Posted (ACTUAL)
June 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 262.686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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