NCT04163666

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,

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
152

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable stroke

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

First Submitted

Initial submission to the registry

November 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

November 6, 2019

Last Update Submit

June 24, 2022

Conditions

StrokeHemiparesis

Keywords

StrokeUpper memberNeurorehabilitationMirror therapyTherapeutic cognitive exercisePerfetti

Outcome Measures

Primary Outcomes (1)

  • Functionality of the affected upper member.

    Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)

    3 months

Secondary Outcomes (5)

  • Spasticity of the upper member

    3 months

  • Cognitive performance.

    3 months

  • Emotional state and quality of life.

    3 months

  • Basic Daily Living Activities

    3 months

  • Instrumental activities of daily living

    3 months

Study Arms (3)

Mirror therapy group

EXPERIMENTAL

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

Behavioral: Mirror therapy

Cognitive therapeutic exercise group

EXPERIMENTAL

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

Behavioral: Cognitive therapeutic exercise

Control Group

NO INTERVENTION

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

Interventions

Mirror therapyBEHAVIORAL

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

Mirror therapy group
Cognitive therapeutic exerciseBEHAVIORAL

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

Cognitive therapeutic exercise group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Hospital of Burgos

Burgos, 09006, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32978182DERIVED

MeSH Terms

Conditions

StrokeParesis

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Raul Soto-Camara, PhD

    Burgos University

    PRINCIPAL INVESTIGATOR

  • Jeronimo Gonzalez-Bernal, PhD

    Burgos University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raul Soto-Camara, PhD

CONTACT

+34 673192039rscamara@ubu.es

Jeronimo Gonzalez-Bernal, PhD

CONTACT

+34 947499108jejavier@ubu.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 15, 2019

Study Start

January 1, 2020

Primary Completion

October 30, 2022

Study Completion

October 31, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)