Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: tDCS (ELDITH) and RAT (REAplan)

• Registration Number: NCT02512289
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

Detailed Description

tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.

Study Timeline

• Study Start: 2014-01-09
• Primary Completion: 2014-01-09
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2015-07-27
• Study Completion: 2015-07-30
• Study First Posted: 2015-07-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• stroke with at least slight deficit in upper limb

Exclusion Criteria

• epilepsy
• contraindication to tDCS
• presence of metal in the head
• inability to understand/complete behavioural tasks
• chronic intake of alcohol or recreative drugs
• major health condition (e.g. terminal renal failure, instable heart failure etc ...)
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real stimulation	tDCS (ELDITH) and RAT (REAplan)	real tDCS associated with robot-assisted therapy (RAT)
Sham stimulation	tDCS (ELDITH) and RAT (REAplan)	Sham tDCS associated with RAT

Primary Outcome Measures

Name	Time	Method
Upper Limb Kinematics	kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

Secondary Outcome Measures

Name	Time	Method
Box and Block test	Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Purdue Pegboard Test	Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

Trial Locations

Locations (2)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussel, Belgium

CHU Dinant-Godinne UCL; 🇧🇪 Mont Godinne, Belgium