Clinical trial NCT04163666: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Stroke
Upper member
Neurorehabilitation
Mirror therapy
Therapeutic cognitive exercise
Perfetti
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2019-11-15
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Functionality of the affected upper member.
timeFrame: 3 months
Secondary outcomes:
measure: Spasticity of the upper member
timeFrame: 3 months
measure: Cognitive performance.
timeFrame: 3 months
measure: Emotional state and quality of life.
timeFrame: 3 months
measure: Basic Daily Living Activities
timeFrame: 3 months
measure: Instrumental activities of daily living
timeFrame: 3 months
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Universitary Hospital of Burgos
Study officials:
affiliation: Burgos University
name: Raul Soto-Camara, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Burgos University
name: Jeronimo Gonzalez-Bernal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.