- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104102
Biomedical Instrumentation in the Study of Mirror Therapy in Elderly's Hands Motor Activity
April 3, 2014 updated by: Universidade do Vale do Paraíba
Check if the Mirror therapy represents an effective method in improving the motor activity of the hands of institutionalized elderly.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Among the various functions impaired by aging there is the muscle function, which indirectly affects the quality of life for seniors, since it is crucial to the progressive increase of the debilitating condition, leading to difficulties in carrying out everyday tasks and often making them dependent on the assistance of others.
The possible neural mechanisms underlying this decrease in muscle function associated with aging include changes undefined in Central Nervous System, a delay in conduction velocity of motor nerve fibers and in transmission of the neuromuscular junction.
In this context, it is necessary to develop procedures that reduce the functional losses and decrease the negative effects of the aging process, increasing the quality of life for seniors.
Mirror Therapy (MT) is the one of those possible procedures, which is based on the activation of mirror neurons from the illusion generated by viewing the reflection of a member in a mirror.
When performing a movement with a member who is in your field of vision, generated the reflection in the mirror is able to offer the brain a new, albeit illusory visual stimulus, suggesting that covert member is moving.
This illusion promotes the activation of mirror neurons located in the sensorimotor cortex region and the progression of therapy, this activation drives cortical plasticity that promotes the reestablishment of functions, such as motor coordination and increased range of motion.
Therefore, MT is a promising technique to reduce the functional losses of aging.
It is then suggested the implementation of a protocol for functional recovery of MT hands in institutionalized elderly and the measurement of electromyographic activity of the wrist, the range and speed of movement, the writing skill and the application of a questionnaire to Katz index calculation in order to investigate whether the technique can benefit this public.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rani S Alves, Graduate
- Phone Number: 5512981638109
- Email: rani.souzaalves@gmail.com
Study Contact Backup
- Name: Mário O Lima, Professor
- Phone Number: 2066 551239471000
- Email: mol@univap.br
Study Locations
-
-
São Paulo
-
São José dos Campos, São Paulo, Brazil, 12244000
- Recruiting
- Laboratory of Sensory and Motor Rehabilitation Engineering
-
Contact:
- Mário O Lima, Professor
- Phone Number: 2066 551239471000
- Email: mol@univap.br
-
Contact:
- Rani S Alves, Masters
- Phone Number: 5512981638109
- Email: rani.souzaalves@gmail.com
-
Principal Investigator:
- Rani S Alves, Graduate
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60 years old or more
- Institutionalized elderly
- Ability to understand and sign the Informed Consent Form. In case of illiteracy, the term will be read to the volunteer and signed by him in the case of functional illiteracy or by officials of the asylum
- Ability to perform analysis of writing skills throughout the proposed protocol
- Cognitive preserved, being able to respond to the examiner's command
Exclusion Criteria:
- Disabling pain to perform movements with their arms
- Active infection and rash at the application site of EMG
- Severe uncorrected visual deficit
- Deficit uncorrected severe hearing
- Neurological disorders
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mirror group
Composed of 30 volunteers who carry out the mirror therapy, whose name shall Mirror Group (MG).
|
Mirror Therapy, which is based on the activation of mirror neurons from the illusion generated by viewing the reflection of a member in a mirror, that is, intended to facilitate the movement through the practice of bilateral symmetric activities, since it is able to stimulate cortical plasticity, promoting reversal of the decrease and the reestablishment of motor function.
|
Experimental: Control Group - kinesiotherapy
Called by Control Group (CG), composed of 30 volunteers who will carry out the kinesiotherapy with the same sequence of movements for the Mirror Therapy that the MG, but without the view in the mirror, since it will be blocked.
|
Hands movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electromyography
Time Frame: 6 weeks
|
Muscle electrical activity will be assessed at two different times, one related to the collection along with the dynamometer and another related to the simultaneous collection accelerometer.It is expected that after treatment with Mirror Therapy for 2 weeks has been an improvement of sensorimotor functions, gain muscle strength , uniformity of muscle fiber recruitment and improves muscle synergy and gain in speed of movements.
|
6 weeks
|
Dynamometry
Time Frame: 6 weeks
|
Manual strength will be assessed with the electromyography, asking the volunteer to perform the maximal volunteer contraction when pressing the portable manual dynamometer.
It is expected that after treatment with Mirror Therapy for 2 weeks has been an improvement of muscle strength.
|
6 weeks
|
Functionality
Time Frame: 6 weeks
|
The functionality will be measure by the Katz index during the period of the study.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion
Time Frame: 6 weeks
|
The range of motion will be taken for the movements of flexion and extension of the wrist.
|
6 weeks
|
Writing skill
Time Frame: 6 weeks
|
The volunteers will writing a specified phrase and they will received a paper with four four geometric forms (square, triangle, circle and rhombus) to follow the line.
This task should be done for both hands.
The skill will be analysed by using a computer software developed to calculate the distances between the original line of the form and the line performed by the volunteer.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rani S Alves, Graduate, Universidade do Vale do Paraíba
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
January 1, 2014
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
February 7, 2014
First Submitted That Met QC Criteria
April 3, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Estimate)
April 4, 2014
Last Update Submitted That Met QC Criteria
April 3, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24581613.0.0000.5503
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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