Transcranial Direct Current Stimulation Acute Stroke Walking

Not Applicable

• Conditions: Acute Stroke
• Interventions: Device: Anodal Transcranial Direct Current Stimulation

• Registration Number: NCT04349488
• Lead Sponsor: University of Liege

Brief Summary

16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.

Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.

The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study Start: 2020-04-16
• Study First Posted: 2020-04-16
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• First Ever Stroke
• Motor or sensory deficit
• Understands and follows orders
• Signed inform consent

Exclusion Criteria

• One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Anodal Transcranial Direct Current Stimulation	Anode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks
Placebo	Anodal Transcranial Direct Current Stimulation	Anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Primary Outcome Measures

Name	Time	Method
Changes Postural Assessment Scale For Stroke	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4	alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.
Changes Time Up & Go	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4	To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.
Changes Four Square Step Test	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4	The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.
Changes Trunk Impairment Scale	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4	alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.
Changes 10 meter walking test	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4	10 meter walking test, the faster the better
Changes Berg Balance Scale	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4	Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.

Trial Locations

Locations (1)

Liege Univeristy Hospital; 🇧🇪 Liege, Belgium