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

NCT ID: NCT03815266

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2022-04-14

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient with first ischemic or hemorrhagic stroke

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).

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: DIAGNOSTIC_TEST

transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current.

Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT).

Computerized Mirror Therapy (CMT)

Intervention Type: DIAGNOSTIC_TEST

Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).

Tolerance Assessment Questionnaire

Intervention Type: DIAGNOSTIC_TEST

The Tolerance Assessment Questionnaire will be completed at the end of each session.

Ashworth's scale

Intervention Type: DIAGNOSTIC_TEST

Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.

Frenchay arm test

Intervention Type: DIAGNOSTIC_TEST

Frenchay arm test evaluates your abilities with the affected hand to perform several actions.

This test will be completed before the start of the program, at the end of the program and one month after.

Abilhand questionnaire

Intervention Type: DIAGNOSTIC_TEST

Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected.

This test will be completed before the start of the program, at the end of the program and one month after.

Fugl-Meyer test

Intervention Type: DIAGNOSTIC_TEST

Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected.

This test will be completed before the start of the program, at the end of the program and one month after.

Goal Attainment Scaling (GAS)

Intervention Type: DIAGNOSTIC_TEST

Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program.

These goals will be checked at the end of the program and one month after.

Interventions

transcranial Direct Current Stimulation (tDCS)

transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current.

Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT).

Intervention Type: DIAGNOSTIC_TEST

Computerized Mirror Therapy (CMT)

Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).

Intervention Type: DIAGNOSTIC_TEST

Tolerance Assessment Questionnaire

The Tolerance Assessment Questionnaire will be completed at the end of each session.

Intervention Type: DIAGNOSTIC_TEST

Ashworth's scale

Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.

Intervention Type: DIAGNOSTIC_TEST

Frenchay arm test

Frenchay arm test evaluates your abilities with the affected hand to perform several actions.

This test will be completed before the start of the program, at the end of the program and one month after.

Intervention Type: DIAGNOSTIC_TEST

Abilhand questionnaire

Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected.

This test will be completed before the start of the program, at the end of the program and one month after.

Intervention Type: DIAGNOSTIC_TEST

Fugl-Meyer test

Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected.

This test will be completed before the start of the program, at the end of the program and one month after.

Intervention Type: DIAGNOSTIC_TEST

Goal Attainment Scaling (GAS)

Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program.

These goals will be checked at the end of the program and one month after.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Intensive Visual Simulation3 (IVS3)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal GIRAUX, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-A01883-52

Identifier Type: OTHER

Identifier Source: secondary_id

1708098

Identifier Type: -

Identifier Source: org_study_id