Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Stroke
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment (Upper Extremity)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Chronic stage of stroke (\> 6 months)
- •No active finger extension/hand opening of the paretic side
Exclusion Criteria
- •Pregnancy
- •Metal implants
- •Pacemaker
Outcomes
Primary Outcomes
Fugl-Meyer Assessment (Upper Extremity)
Time Frame: change from baseline to both directly after intervention and 3 months after
Secondary Outcomes
- Modified Ashworth Scale (MAS)(change from baseline to both directly after intervention and 3 months after)
- National Institute of Stroke Scale (NIHSS)(baseline)
- Stroke Impact Scale(change from baseline to both directly after intervention and 3 months after)
- Hospital Anxiety and Depression Scale(change from baseline to both directly after intervention and 3 months after)
- Neurological Fatigue Index(change from baseline to both directly after intervention and 3 months after)
- Credibility/Expectancy Questionnaire(change from baseline to both directly after intervention and 3 months after)
- Action Research Arm Test (ARAT)(change from baseline to both directly after intervention and 3 months after)
- 10m walking test(change from baseline to both directly after intervention and 3 months after)
- CAHAI-13(change from baseline to both directly after intervention and 3 months after)
- NEO-Fünf-Faktoren Inventar(baseline)
- Berlin Social Support Scale(change from baseline to both directly after intervention and 3 months after)
- Barthel Index(change from baseline to both directly after intervention and 3 months after)
- Arm-A(change from baseline to both directly after intervention and 3 months after)
- Fugl-Meyer Assessment (Lower Extremity)(change from baseline to both directly after intervention and 3 months after)
- Modified Rankin Scale (mRS)(change from baseline to both directly after intervention and 3 months after)
- EQ-5D(change from baseline to both directly after intervention and 3 months after)
- Situational Motivation Scale(change from baseline to both directly after intervention and 3 months after)