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

Stroke Clinical Trial

— SIMSTIM  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03815266
• Other study ID #: 1708098
• Secondary ID: 2018-A01883-52
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: April 14, 2022

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 14, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• 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).
• 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).
• Tolerance Assessment Questionnaire
The Tolerance Assessment Questionnaire will be completed at the end of each session.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test	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.	Day 40
Secondary	Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test	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.	Day 70
Secondary	occurrence of epileptic seizure	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.	Day 40
Secondary	occurrence of Anxiety crisis	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.	Day 40
Secondary	Tolerance Assessment Questionnaire	Analysis the results of the Tolerance Assessment Questionnaire.	Up to day 70
Secondary	Evaluation of the program by Goal Attainment Scaling (GAS)	Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.	Day 40
Secondary	Evaluation of the program by Goal Attainment Scaling (GAS)	Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.	Day 70
Secondary	Quantitative improvement of the deficiencies - Fugl-Meyer test	Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.	Day 40
Secondary	Quantitative improvement of the deficiencies - Fugl-Meyer test	Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.	Day 70
Secondary	Abilities to perform several activities - Abilhand questionnaire	Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.	Day 40
Secondary	Abilities to perform several activities - Abilhand questionnaire	Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.	Day 70