Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163666
• Other study ID #: UBU-HUBU: MT-CTE
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: June 2022
• Source: Universidad de Burgos
• Contact: Raul Soto-Camara, PhD
• Phone: +34 673192039
• Email: rscamara[@]ubu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: October 31, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
Spain	Universitary Hospital of Burgos	Burgos

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Burgos	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functionality of the affected upper member.	Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)	3 months
Secondary	Spasticity of the upper member	Measurement by Ashworth Scale: Score between 0 (best situation) and 5 (worst situation)	3 months
Secondary	Cognitive performance.	Measurement by Montreal Cognitive Assessment Scale: Score between 0 (worst cognitive situation ) and 30 (best cognitive situation)	3 months
Secondary	Emotional state and quality of life.	Measurement by Post-Stroke Quality of Life Scale: Score between 30 (best state) and 155 (worst state)	3 months
Secondary	Basic Daily Living Activities	Measurement by Functional Independence Measure - Functional Assessment Measure: Score between 30 (worst situation) and 210 (best situation)	3 months
Secondary	Instrumental activities of daily living	Measurement by Lawton-Brody Index: Score between 0 (worst state) and 6 (best state)	3 months