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Completed

NCT Number: NCT03947645

Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

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.

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Key information

Conditions

Chronic Stroke

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipsilesional stimulation

Device

Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle

Contralesional stimulation

Device

Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Primary outcomes

  1. Fugl-Meyer Assessment (Upper Extremity)

    Time frame: change from baseline to both directly after intervention and 3 months after

Secondary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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.

  2. Arm-A

    Time frame: 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).

  3. Modified Ashworth Scale (MAS)

    Time frame: 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).

  4. Fugl-Meyer Assessment (Lower Extremity)

    Time frame: change from baseline to both directly after intervention and 3 months after

    Assessment of motor impairment of the lower extremity.

  5. 10m walking test

    Time frame: change from baseline to both directly after intervention and 3 months after

    Assessment of motor impairment of the lower extremity.

  6. National Institute of Stroke Scale (NIHSS)

    Time frame: baseline

    Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item).

  7. Modified Rankin Scale (mRS)

    Time frame: 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).

  8. EQ-5D

    Time frame: 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.

  9. CAHAI-13

    Time frame: 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).

  10. Stroke Impact Scale

    Time frame: 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).

  11. Barthel Index

    Time frame: 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).

  12. Hospital Anxiety and Depression Scale

    Time frame: 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).

  13. Neurological Fatigue Index

    Time frame: 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.

  14. NEO-Fünf-Faktoren Inventar

    Time frame: baseline

    Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.

  15. Situational Motivation Scale

    Time frame: 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).

  16. Berlin Social Support Scale

    Time frame: 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.

  17. Credibility/Expectancy Questionnaire

    Time frame: 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).

Other outcomes

  1. Elektroencephalography in resting and active states

    Time frame: change from baseline to both directly after intervention and 3 months after

  2. Input-Output curves and motor maps with transcranial magnetic stimulation

    Time frame: change from baseline to both directly after intervention and 3 months after

  3. Task-related and evoked electromyography

    Time frame: change from baseline to both directly after intervention and 3 months after

  4. Camera and marker-based motion capturing

    Time frame: change from baseline to both directly after intervention and 3 months after

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 13, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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