- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163666
Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Raul Soto-Camara, PhD, Burgos University
- Principal Investigator: Jeronimo Gonzalez-Bernal, PhD, Burgos University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBU-HUBU: MT-CTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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