Feasibility Study to Evaluate the Observance Rehabilitation of Upper Limbs by Visual-motor Simulation Associated at Transcranial Direct Current Stimulation (tDCS) in Hemiparetic Patient Post-stroke

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Diagnostic Test: transcranial Direct Current Stimulation (tDCS); Diagnostic Test: Computerized Mirror Therapy (CMT); Diagnostic Test: Tolerance Assessment Questionnaire; Diagnostic Test: Ashworth's scale; Diagnostic Test: Frenchay arm test; Diagnostic Test: Abilhand questionnaire; Diagnostic Test: Fugl-Meyer test; Diagnostic Test: Goal Attainment Scaling (GAS)

• Registration Number: NCT03815266
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Although the mirror therapy is recognized as effective, its practice is difficult, especially with hemiplegic patients. It is difficult for them to understand, control the movements and carry out a double task with the two upper limbs. The implementation of a Computerized Mirror Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit these problems by proposing pre-recorded sessions, not limited to the right or left hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be proposed. There is currently a consensus to consider the use of transcranial Direct Current Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the effectiveness of training techniques. Although all motor therapies can theoretically benefit from increased effectiveness by the addition of transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of the upper limb applied.

Detailed Description

The primary objective of this study is to investigate the feasibility of a program combining Computerized Mirror Therapy (CMT) with dual- transcranial Direct Current Stimulation (tDCS) stimulation by evaluating observance to hemiparetic stroke patients.

Study Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2022-03-07
• Study Completion: 2022-04-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patient with first ischemic or hemorrhagic stroke for less than one year, having not recidivated since then and responsible for initially complete left or right hemiplegia
• Modified Frenchay arm test score <70 (/ 100)
• Without a neurological history other than stroke
• Having signed the written consent and affiliated or entitled to a social security scheme

Exclusion Criteria

• Patient with contraindications to transcranial Direct Current Stimulation (tDCS) or Transcranial Magnetic Stimulation (TMS) (brain metal implant, pacemaker, other implanted active medical device)
• Patient who didn't have cerebral Magnetic Resonance Imaging (MRI) imaging during their stroke
• With complete lesion of the primary motor cortex
• With alcohol / drug dependence
• With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignant disease, severe renal or pulmonary disease
• With a history of disabling associated disease
• With cerebellar syndrome
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with first ischemic or hemorrhagic stroke	Ashworth's scale	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	Goal Attainment Scaling (GAS)	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	transcranial Direct Current Stimulation (tDCS)	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	Tolerance Assessment Questionnaire	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	Frenchay arm test	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	Abilhand questionnaire	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	Computerized Mirror Therapy (CMT)	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
Patient with first ischemic or hemorrhagic stroke	Fugl-Meyer test	Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).

Primary Outcome Measures

Name	Time	Method
Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)	Up to Day 40	Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study.

Secondary Outcome Measures

Name	Time	Method
Abilities to perform several activities - Abilhand questionnaire	Day 70	Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test	Day 70	To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb.; It is will be measured by Frenchay arm test.
occurrence of Anxiety crisis	Day 40	Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of anxiety crisis report by adverse event and serious adverse events.
Tolerance Assessment Questionnaire	Up to day 70	Analysis the results of the Tolerance Assessment Questionnaire.
Evaluation of the program by Goal Attainment Scaling (GAS)	Day 70	Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
Quantitative improvement of the deficiencies - Fugl-Meyer test	Day 70	Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
occurrence of epileptic seizure	Day 40	Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of epileptic seizure report by adverse event and serious adverse events.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France