NCT03815266

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

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
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).
DIAGNOSTIC_TEST	Tolerance Assessment Questionnaire	The Tolerance Assessment Questionnaire will be completed at the end of each session.
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.
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.
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.
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.
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.

Timeline

• Start date: 2018-09-20
• Primary completion: 2022-03-07
• Completion: 2022-04-14
• First posted: 2019-01-24
• Last updated: 2023-04-27

Locations

1 site across 1 country: France