Chronic Stroke
Conditions
Brief summary
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
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.
Interventions
DEVICEIpsilesional stimulation
Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment (Upper Extremity) | change from baseline to both directly after intervention and 3 months after |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | change from baseline to both directly after intervention and 3 months after | Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients. |
| Arm-A | change from baseline to both directly after intervention and 3 months after | 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). |
| Modified Ashworth Scale (MAS) | change from baseline to both directly after intervention and 3 months after | Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid). |
| Fugl-Meyer Assessment (Lower Extremity) | change from baseline to both directly after intervention and 3 months after | Assessment of motor impairment of the lower extremity. |
| 10m walking test | change from baseline to both directly after intervention and 3 months after | Assessment of motor impairment of the lower extremity. |
| National Institute of Stroke Scale (NIHSS) | baseline | Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item). |
| Modified Rankin Scale (mRS) | change from baseline to both directly after intervention and 3 months after | Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead). |
| EQ-5D | change from baseline to both directly after intervention and 3 months after | 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. |
| CAHAI-13 | change from baseline to both directly after intervention and 3 months after | Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence). |
| Stroke Impact Scale | change from baseline to both directly after intervention and 3 months after | Questionnaire on subjective impact of stroke on daily living and health status. Scale ranges from 1 (most negative answer) to 5 (most positive answer). |
| Barthel Index | change from baseline to both directly after intervention and 3 months after | 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). |
| Hospital Anxiety and Depression Scale | change from baseline to both directly after intervention and 3 months after | Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer). |
| Neurological Fatigue Index | change from baseline to both directly after intervention and 3 months after | Questionnaire on fatigue in the last two weeks. Scale ranges from no agreement at all, no agreement, agreement to some extent to full agreement. |
| NEO-Fünf-Faktoren Inventar | baseline | Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement. |
| Situational Motivation Scale | change from baseline to both directly after intervention and 3 months after | Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree). |
| Berlin Social Support Scale | change from baseline to both directly after intervention and 3 months after | 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. |
| Credibility/Expectancy Questionnaire | change from baseline to both directly after intervention and 3 months after | Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive). |
Countries
Germany
Outcome results
None listed