Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

Study Overview
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Brief Summary
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Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

Detailed Description
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Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere. The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.

Official Title
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Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity

Conditions
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Chronic Stroke

Intervention / Treatment
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* Device: Ipsilesional stimulation
* Device: Contralesional stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Chronic stage of stroke (> 6 months) No active finger extension/hand opening of the paretic side Exclusion Criteria: Pregnancy Epilepsy Metal implants Pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipsilesional stimulation<br>Ipsilesional stimulation | Device: Ipsilesional stimulation<br>* Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle<br>|
| Experimental: Contralesional stimulation<br>Contralesional stimulation | Device: Contralesional stimulation<br>* Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (Upper Extremity) |  | change from baseline to both directly after intervention and 3 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) | Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients. | change from baseline to both directly after intervention and 3 months after | 
| Arm-A | Questionnaire on capability to care for the paretic arm in different situations of daily living. Scale ranges from 0 (no problems) to 4 (impossible to do). | change from baseline to both directly after intervention and 3 months after | 
| Modified Ashworth Scale (MAS) | Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid). | change from baseline to both directly after intervention and 3 months after | 
| Fugl-Meyer Assessment (Lower Extremity) | Assessment of motor impairment of the lower extremity. | change from baseline to both directly after intervention and 3 months after | 
| 10m walking test | Assessment of motor impairment of the lower extremity. | change from baseline to both directly after intervention and 3 months after | 
| National Institute of Stroke Scale (NIHSS) | Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item). | baseline | 
| Modified Rankin Scale (mRS) | Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead). | change from baseline to both directly after intervention and 3 months after | 
| EQ-5D | Questionnaire on subjective health status. Patients should rate their health status for that day in different tasks of daily living on a scale from no problems, minor problems, moderate problems, big problems to not possible at all. | change from baseline to both directly after intervention and 3 months after | 
| CAHAI-13 | Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence). | change from baseline to both directly after intervention and 3 months after | 
| Stroke Impact Scale | Questionnaire on subjective impact of stroke on daily living and health status. Scale ranges from 1 (most negative answer) to 5 (most positive answer). | change from baseline to both directly after intervention and 3 months after | 
| Barthel Index | Questionnaire on extent to which patients can perform activities of daily living on their own. Patients can reach 0 (cannot perform any task) to a maximum of 100 points (can do everything on their own). | change from baseline to both directly after intervention and 3 months after | 
| Hospital Anxiety and Depression Scale | Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer). | change from baseline to both directly after intervention and 3 months after | 
| Neurological Fatigue Index | Questionnaire on fatigue in the last two weeks. Scale ranges from no agreement at all, no agreement, agreement to some extent to full agreement. | change from baseline to both directly after intervention and 3 months after | 
| NEO-Fünf-Faktoren Inventar | Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement. | baseline | 
| Situational Motivation Scale | Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree). | change from baseline to both directly after intervention and 3 months after | 
| Berlin Social Support Scale | Questionnaire to evaluate social support. Patients should rate different questions regarding their most important attachment figure ranging from no agreement at all, no agreement, agreement to some extent to full agreement. | change from baseline to both directly after intervention and 3 months after | 
| Credibility/Expectancy Questionnaire | Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive). | change from baseline to both directly after intervention and 3 months after |