Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients

NCT ID: NCT04163666

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Stroke Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mirror therapy group

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

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type BEHAVIORAL

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

Cognitive therapeutic exercise group

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

Group Type EXPERIMENTAL

Cognitive therapeutic exercise

Intervention Type BEHAVIORAL

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mirror therapy

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

Cognitive therapeutic exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Castilla-León Health Service

OTHER

Sponsor Role collaborator

Universidad de Burgos

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raul Soto-Camara, PhD

Role: PRINCIPAL_INVESTIGATOR

Burgos University

Jeronimo Gonzalez-Bernal, PhD

Role: PRINCIPAL_INVESTIGATOR

Burgos University

Locations

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Universitary Hospital of Burgos

Burgos, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Raul Soto-Camara, PhD

Role: CONTACT

+34 673192039

Jeronimo Gonzalez-Bernal, PhD

Role: CONTACT

+34 947499108

Facility Contacts

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Raul Soto-Cámara, PhD

Role: primary

+34 673192039

Jeronimo Gonzalez-Bernal, PhD

Role: backup

+34 947499108

References

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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.

Reference Type DERIVED
PMID: 32978182 (View on PubMed)

Other Identifiers

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UBU-HUBU: MT-CTE

Identifier Type: -

Identifier Source: org_study_id

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