Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients

June 24, 2022 updated by: Universidad de Burgos

Effects of Mirror Therapy and Cognitive Therapeutic Exercise on Improvements to the Upper Member Functions of Stroke Patients: a Randomized Clinical Test Study Protocol

This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,

Study Overview

Detailed Description

Objective: To assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients.

Design and setting: A randomized clinical trial of three parallel groups.

Population: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the University Hospital of Burgos (HUBU).

Measurements and intervention: Functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. The intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. No additional intervention with the participants of the control group will be completed.

Study Type

Interventional

Enrollment (Anticipated)

152

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: Raul Soto-Cámara, PhD
  • Phone Number: +34 673192039
  • Email: rscamara@ubu.es

Study Contact Backup

  • Name: Jeronimo Gonzalez-Bernal, PhD
  • Phone Number: +34 947499108
  • Email: jejavier@ubu.es

Study Locations

      • Burgos, Spain, 09006
        • Recruiting
        • Universitary Hospital of Burgos
        • Contact:
          • Raul Soto-Cámara, PhD
          • Phone Number: +34 673192039
          • Email: rscamara@ubu.es
        • Contact:
          • Jeronimo Gonzalez-Bernal, PhD
          • Phone Number: +34 947499108
          • Email: jejavier@ubu.es

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke,
  • Movements of the affected upper members classified between stages II and IV on the Brunnstrom Scale
  • Score on the Montreal Cognitive Assessment (MOCA) scale equal to or over 26

Exclusion Criteria:

  • Heminegligence
  • Wernicke's aphasia
  • Visual deficits (homonymous hemianopsia)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirror therapy group
The mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning.
The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for mirror therapy, while the remaining 30 minutes will be for task-oriented motor learning
Experimental: Cognitive therapeutic exercise group
The cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning.
The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for cognoscitive therapeutic exercise, while the remaining 30 minutes will be for task-oriented motor learning
No Intervention: Control Group
No additional intervention with the participants of this group will be completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality of the affected upper member.
Time Frame: 3 months
Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity of the upper member
Time Frame: 3 months
Measurement by Ashworth Scale: Score between 0 (best situation) and 5 (worst situation)
3 months
Cognitive performance.
Time Frame: 3 months
Measurement by Montreal Cognitive Assessment Scale: Score between 0 (worst cognitive situation ) and 30 (best cognitive situation)
3 months
Emotional state and quality of life.
Time Frame: 3 months
Measurement by Post-Stroke Quality of Life Scale: Score between 30 (best state) and 155 (worst state)
3 months
Basic Daily Living Activities
Time Frame: 3 months
Measurement by Functional Independence Measure - Functional Assessment Measure: Score between 30 (worst situation) and 210 (best situation)
3 months
Instrumental activities of daily living
Time Frame: 3 months
Measurement by Lawton-Brody Index: Score between 0 (worst state) and 6 (best state)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Raul Soto-Camara, PhD, Burgos University
  • Principal Investigator: Jeronimo Gonzalez-Bernal, PhD, Burgos University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)

January 1, 2020

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

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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