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Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

Primary Purpose

Chronic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ipsilesional stimulation
Contralesional stimulation
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ipsilesional stimulation

Contralesional stimulation

Arm Description

Ipsilesional stimulation

Contralesional stimulation

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (Upper Extremity)

Secondary Outcome Measures

Action Research Arm Test (ARAT)
Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients.
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).
Modified Ashworth Scale (MAS)
Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid).
Fugl-Meyer Assessment (Lower Extremity)
Assessment of motor impairment of the lower extremity.
10m walking test
Assessment of motor impairment of the lower extremity.
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).
Modified Rankin Scale (mRS)
Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead).
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.
CAHAI-13
Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence).
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).
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).
Hospital Anxiety and Depression Scale
Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer).
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.
NEO-Fünf-Faktoren Inventar
Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.
Situational Motivation Scale
Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree).
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.
Credibility/Expectancy Questionnaire
Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive).

Full Information

First Posted
May 2, 2019
Last Updated
September 28, 2021
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03947645
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipsilesional stimulation
Arm Type
Experimental
Arm Description
Ipsilesional stimulation
Arm Title
Contralesional stimulation
Arm Type
Experimental
Arm Description
Contralesional stimulation
Intervention Type
Device
Intervention Name(s)
Ipsilesional stimulation
Intervention Description
Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
Intervention Type
Device
Intervention Name(s)
Contralesional stimulation
Intervention Description
Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (Upper Extremity)
Time Frame
change from baseline to both directly after intervention and 3 months after
Secondary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients.
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Arm-A
Description
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).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Modified Ashworth Scale (MAS)
Description
Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Fugl-Meyer Assessment (Lower Extremity)
Description
Assessment of motor impairment of the lower extremity.
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
10m walking test
Description
Assessment of motor impairment of the lower extremity.
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
National Institute of Stroke Scale (NIHSS)
Description
Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item).
Time Frame
baseline
Title
Modified Rankin Scale (mRS)
Description
Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
EQ-5D
Description
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.
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
CAHAI-13
Description
Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Stroke Impact Scale
Description
Questionnaire on subjective impact of stroke on daily living and health status. Scale ranges from 1 (most negative answer) to 5 (most positive answer).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Barthel Index
Description
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).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Hospital Anxiety and Depression Scale
Description
Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Neurological Fatigue Index
Description
Questionnaire on fatigue in the last two weeks. Scale ranges from no agreement at all, no agreement, agreement to some extent to full agreement.
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
NEO-Fünf-Faktoren Inventar
Description
Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.
Time Frame
baseline
Title
Situational Motivation Scale
Description
Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree).
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Berlin Social Support Scale
Description
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.
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Credibility/Expectancy Questionnaire
Description
Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive).
Time Frame
change from baseline to both directly after intervention and 3 months after
Other Pre-specified Outcome Measures:
Title
Elektroencephalography in resting and active states
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Input-Output curves and motor maps with transcranial magnetic stimulation
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Task-related and evoked electromyography
Time Frame
change from baseline to both directly after intervention and 3 months after
Title
Camera and marker-based motion capturing
Time Frame
change from baseline to both directly after intervention and 3 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

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