Clinical trial NCT03947645: Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients
Official title: Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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
* Epilepsy
* Metal implants
* Pacemaker

Primary outcomes:
measure: Fugl-Meyer Assessment (Upper Extremity)
timeFrame: change from baseline to both directly after intervention and 3 months after
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Arm-A
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Modified Ashworth Scale (MAS)
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Fugl-Meyer Assessment (Lower Extremity)
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: 10m walking test
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: National Institute of Stroke Scale (NIHSS)
timeFrame: baseline
measure: Modified Rankin Scale (mRS)
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: EQ-5D
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: CAHAI-13
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Stroke Impact Scale
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Barthel Index
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Hospital Anxiety and Depression Scale
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Neurological Fatigue Index
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: NEO-Fünf-Faktoren Inventar
timeFrame: baseline
measure: Situational Motivation Scale
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Berlin Social Support Scale
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Credibility/Expectancy Questionnaire
timeFrame: change from baseline to both directly after intervention and 3 months after
Other outcomes:
measure: Elektroencephalography in resting and active states
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Input-Output curves and motor maps with transcranial magnetic stimulation
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Task-related and evoked electromyography
timeFrame: change from baseline to both directly after intervention and 3 months after
measure: Camera and marker-based motion capturing
timeFrame: change from baseline to both directly after intervention and 3 months after
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: Baden-Württemberg
Study officials:
References: