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Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients

Primary Purpose

Stroke, Hemiparesis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mirror therapy
Cognitive therapeutic exercise
Sponsored by
Universidad de Burgos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper member, Neurorehabilitation, Mirror therapy, Therapeutic cognitive exercise, Perfetti

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universitary Hospital of BurgosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Mirror therapy group

Cognitive therapeutic exercise group

Control Group

Arm Description

The mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning.

The cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning.

No additional intervention with the participants of this group will be completed.

Outcomes

Primary Outcome Measures

Functionality of the affected upper member.
Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2019
Last Updated
June 24, 2022
Sponsor
Universidad de Burgos
Collaborators
Castilla-León Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT04163666
Brief Title
Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients
Official Title
Effects of Mirror Therapy and Cognitive Therapeutic Exercise on Improvements to the Upper Member Functions of Stroke Patients: a Randomized Clinical Test Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Burgos
Collaborators
Castilla-León Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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,
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Stroke, Upper member, Neurorehabilitation, Mirror therapy, Therapeutic cognitive exercise, Perfetti

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy group
Arm Type
Experimental
Arm Description
The mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning.
Arm Title
Cognitive therapeutic exercise group
Arm Type
Experimental
Arm Description
The cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No additional intervention with the participants of this group will be completed.
Intervention Type
Behavioral
Intervention Name(s)
Mirror therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive therapeutic exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Functionality of the affected upper member.
Description
Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Spasticity of the upper member
Description
Measurement by Ashworth Scale: Score between 0 (best situation) and 5 (worst situation)
Time Frame
3 months
Title
Cognitive performance.
Description
Measurement by Montreal Cognitive Assessment Scale: Score between 0 (worst cognitive situation ) and 30 (best cognitive situation)
Time Frame
3 months
Title
Emotional state and quality of life.
Description
Measurement by Post-Stroke Quality of Life Scale: Score between 30 (best state) and 155 (worst state)
Time Frame
3 months
Title
Basic Daily Living Activities
Description
Measurement by Functional Independence Measure - Functional Assessment Measure: Score between 30 (worst situation) and 210 (best situation)
Time Frame
3 months
Title
Instrumental activities of daily living
Description
Measurement by Lawton-Brody Index: Score between 0 (worst state) and 6 (best state)
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Soto-Camara, PhD
Phone
+34 673192039
Email
rscamara@ubu.es
First Name & Middle Initial & Last Name or Official Title & Degree
Jeronimo Gonzalez-Bernal, PhD
Phone
+34 947499108
Email
jejavier@ubu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Soto-Camara, PhD
Organizational Affiliation
Burgos University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeronimo Gonzalez-Bernal, PhD
Organizational Affiliation
Burgos University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital of Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Soto-Cámara, PhD
Phone
+34 673192039
Email
rscamara@ubu.es
First Name & Middle Initial & Last Name & Degree
Jeronimo Gonzalez-Bernal, PhD
Phone
+34 947499108
Email
jejavier@ubu.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32978182
Citation
Gonzalez-Santos J, Soto-Camara R, Rodriguez-Fernandez P, Jimenez-Barrios M, Gonzalez-Bernal J, Collazo-Riobo C, Jahouh M, Bravo-Anguiano Y, Trejo-Gabriel-Galan JM. Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial. BMJ Open. 2020 Sep 25;10(9):e035768. doi: 10.1136/bmjopen-2019-035768.
Results Reference
derived

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Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients

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