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

NCT03815266 | Terminated

• 2 other identifiers: 17080982018-A01883-52
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

transcranial Direct Current Stimulation (tDCS); Computerized Mirror Therapy (CMT); hemiparetic; Ischemic; stroke; Intensive Visual Simulation3 (IVS3)

Outcome Measures

Primary Outcomes (1)

• Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)

  Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study.

  Up to Day 40

Secondary Outcomes (11)

• 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 40

• 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

• occurrence of epileptic seizure

  Day 40

• occurrence of Anxiety crisis

  Day 40

• Tolerance Assessment Questionnaire

  Up to day 70

Study Arms (1)

Patient with first ischemic or hemorrhagic stroke

EXPERIMENTAL

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).

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)

Interventions

transcranial Direct Current Stimulation (tDCS) 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).

Patient with first ischemic or hemorrhagic stroke

Computerized Mirror Therapy (CMT) 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).

Also known as: Intensive Visual Simulation3 (IVS3)

Patient with first ischemic or hemorrhagic stroke

Tolerance Assessment Questionnaire DIAGNOSTIC_TEST

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

Patient with first ischemic or hemorrhagic stroke

Ashworth's scale 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.

Patient with first ischemic or hemorrhagic stroke

Frenchay arm test 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.

Patient with first ischemic or hemorrhagic stroke

Abilhand questionnaire 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.

Patient with first ischemic or hemorrhagic stroke

Fugl-Meyer test 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.

Patient with first ischemic or hemorrhagic stroke

Goal Attainment Scaling (GAS) 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.

Patient with first ischemic or hemorrhagic stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal GIRAUX, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: January 24, 2019
• Study Start: September 20, 2018
• Primary Completion: March 7, 2022
• Study Completion: April 14, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)