Muscle Weakness ConditionsNCT02104102
Biomedical Instrumentation in the Study of Mirror Therapy in Elderly's Hands Motor Activity
A study testing Mirror Therapy and Kinesiotherapy in people with Muscle Weakness Conditions, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial summary
Check if the Mirror therapy represents an effective method in improving the motor activity of the hands of institutionalized elderly. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness Conditions
- What is being tested?
- Mirror Therapy and Kinesiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2014
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory of Sensory and Motor Rehabilitation Engineering
São José dos Campos, São Paulo, 12244000
Rani S Alves, Masters, 5512981638109, rani.souzaalves@gmail.com
Mário O Lima, Professor, 551239471000 ext. 2066, mol@univap.br
About this study
Check if the Mirror therapy represents an effective method in improving the motor activity of the hands of institutionalized elderly.
Read the 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.
- Conditions
- Muscle Weakness Conditions
- Being tested
- Mirror Therapy, Kinesiotherapy
- Keywords
- Elderly, mirror therapy, hands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
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.
KinesiotherapyOther
Hands movements.
| Study group | Role | What they receive |
|---|---|---|
| Mirror group | Experimental | Composed of 30 volunteers who carry out the mirror therapy, whose name shall Mirror Group (MG). Receives: Other: Mirror Therapy |
| Control Group - kinesiotherapy | Experimental | 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. Receives: Other: Kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
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.
Measured: 6 weeks
Dynamometry
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.
Measured: 6 weeks
Functionality
The functionality will be measure by the Katz index during the period of the study.
Measured: 6 weeks
Secondary outcomes (2)
Range of motion
The range of motion will be taken for the movements of flexion and extension of the wrist.
Measured: 6 weeks
Writing skill
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Weakness ConditionsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rani S Alves, Graduate, Principal investigator, Universidade do Vale do Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104102
- Sponsor's protocol ID
- 24581613.0.0000.5503
- Status last verified
- Mar 2014
- First submitted
- 7 Feb 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomedical Instrumentation in the Study of Mirror Therapy in Elderly's Hands Motor Activity
- ClinicalTrials.gov ID
- NCT02104102
- Acronym / sponsor ID
- 24581613.0.0000.5503
- Conditions
- Muscle Weakness Conditions
- Keywords
- Elderly, mirror therapy, hands
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Apr 2014 (estimated)
- 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.
Check if the Mirror therapy represents an effective method in improving the motor activity of the hands of institutionalized elderly.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror group | Experimental | Other: Mirror TherapyComposed of 30 volunteers who carry out the mirror therapy, whose name shall Mirror Group (MG). |
| Control Group - kinesiotherapy | Experimental | Other: KinesiotherapyCalled 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 TherapyMirror 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. | Other | Mirror group |
| KinesiotherapyHands movements. | Other | Control Group - kinesiotherapy |
Primary outcome
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.
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.
Functionality
Time frame: 6 weeks
The functionality will be measure by the Katz index during the period of the study.
2 secondary outcomes
Range of motion
Time frame: 6 weeks
Writing skill
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
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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.
Rani S Alves, Graduate principal investigator
Universidade do Vale do Paraíba
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 and Kinesiotherapy in people with Muscle Weakness Conditions, run by Universidade do Vale do Paraíba 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 5 inclusion and 5 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 4 Apr 2014. 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?
Contact Rani S Alves, Graduate (5512981638109, rani.souzaalves@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 6 weeks). The study lists 3 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 4 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.