Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

Not Applicable

• Conditions: Chronic Stroke
• Interventions: Device: Contralesional stimulation; Device: Ipsilesional stimulation

• Registration Number: NCT03947645
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-02-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Contralesional stimulation	Contralesional stimulation	Contralesional stimulation
Ipsilesional stimulation	Ipsilesional stimulation	Ipsilesional stimulation

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (Upper Extremity)	change from baseline to both directly after intervention and 3 months after

Secondary Outcome Measures

Name	Time	Method
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).
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).
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).
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.
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).
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.
10m walking test	change from baseline to both directly after intervention and 3 months after	Assessment of motor impairment of the lower extremity.
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).
NEO-Fünf-Faktoren Inventar	baseline	Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.
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.
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).
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).
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.
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.
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).

Trial Locations

Locations (1)

University Hospital Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany