Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Device: Ipsilesional stimulation; Device: Contralesional stimulation

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • University Hospital Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ipsilesional stimulation	Device: Ipsilesional stimulation; Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
Experimental: Contralesional stimulation	Device: Contralesional stimulation; Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Elektroencephalography in resting and active states	change from baseline to both directly after intervention and 3 months after
Input-Output curves and motor maps with transcranial magnetic stimulation	change from baseline to both directly after intervention and 3 months after
Task-related and evoked electromyography	change from baseline to both directly after intervention and 3 months after
Camera and marker-based motion capturing	change from baseline to both directly after intervention and 3 months after

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: In-Tens

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No