NCT02104102

Brief Summary

Check if the Mirror therapy represents an effective method in improving the motor activity of the hands of institutionalized elderly.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 4, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

February 7, 2014

Last Update Submit

April 3, 2014

Conditions

Muscle Weakness Conditions

Keywords

Elderlymirror therapyhands

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    6 weeks

  • Functionality

    The functionality will be measure by the Katz index during the period of the study.

    6 weeks

Secondary Outcomes (2)

  • Range of motion

    6 weeks

  • Writing skill

    6 weeks

Study Arms (2)

Mirror group

EXPERIMENTAL

Composed of 30 volunteers who carry out the mirror therapy, whose name shall Mirror Group (MG).

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.

Other: Kinesiotherapy

Interventions

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.

Mirror group
KinesiotherapyOTHER

Hands movements.

Control Group - kinesiotherapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Sensory and Motor Rehabilitation Engineering

São José dos Campos, São Paulo, 12244000, Brazil

RECRUITING

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Rani S Alves, Graduate

    Universidade do Vale do Paraíba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rani S Alves, Graduate

CONTACT

5512981638109rani.souzaalves@gmail.com

Mário O Lima, Professor

CONTACT

551239471000mol@univap.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

April 4, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

April 4, 2014

Record last verified: 2014-03

Locations

BR(1)