Chronic StrokeNCT03947645
Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients
A study testing Ipsilesional stimulation and Contralesional stimulation in people with Chronic Stroke, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Ipsilesional stimulation and Contralesional stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Chronic stage of stroke (> 6 months)
- No active finger extension/hand opening of the paretic side
Who cannot join
- Pregnancy
- Epilepsy
- Metal implants
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Stroke
- Being tested
- Ipsilesional stimulation, Contralesional stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipsilesional stimulationDevice
Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
Contralesional stimulationDevice
Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle
| Study group | Role | What they receive |
|---|---|---|
| Ipsilesional stimulation | Experimental | Ipsilesional stimulation Receives: Device: Ipsilesional stimulation |
| Contralesional stimulation | Experimental | Contralesional stimulation Receives: Device: Contralesional stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (Upper Extremity)
Measured: change from baseline to both directly after intervention and 3 months after
Secondary outcomes (17)
Action Research Arm Test (ARAT)
Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: change from baseline to both directly after intervention and 3 months after
10m walking test
Assessment of motor impairment of the lower extremity.
Measured: 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).
Measured: baseline
Modified Rankin Scale (mRS)
Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline
Situational Motivation Scale
Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree).
Measured: 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.
Measured: 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).
Measured: change from baseline to both directly after intervention and 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start2 May 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947645
- Sponsor's protocol ID
- In-Tens
- Status last verified
- Nov 2022
- First submitted
- 2 May 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity
- ClinicalTrials.gov ID
- NCT03947645
- Acronym / sponsor ID
- In-Tens
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipsilesional stimulation | Experimental | Device: Ipsilesional stimulationIpsilesional stimulation |
| Contralesional stimulation | Experimental | Device: Contralesional stimulationContralesional stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Chronic stage of stroke (> 6 months)
- No active finger extension/hand opening of the paretic side
Key exclusion criteria (4 listed)
- Pregnancy
- Epilepsy
- Metal implants
- Pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipsilesional stimulationDevice: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle | Device | Ipsilesional stimulation |
| Contralesional stimulationDevice: contralesional transcranial stimulation, neuromuscular stimulation over target muscle | Device | Contralesional stimulation |
Primary outcome
Fugl-Meyer Assessment (Upper Extremity)
Time frame: change from baseline to both directly after intervention and 3 months after
17 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: change from baseline to both directly after intervention and 3 months after
Arm-A
Time frame: change from baseline to both directly after intervention and 3 months after
Modified Ashworth Scale (MAS)
Time frame: change from baseline to both directly after intervention and 3 months after
Fugl-Meyer Assessment (Lower Extremity)
Time frame: change from baseline to both directly after intervention and 3 months after
10m walking test
Time frame: change from baseline to both directly after intervention and 3 months after
National Institute of Stroke Scale (NIHSS)
Time frame: baseline
Modified Rankin Scale (mRS)
Time frame: change from baseline to both directly after intervention and 3 months after
EQ-5D
Time frame: change from baseline to both directly after intervention and 3 months after
CAHAI-13
Time frame: change from baseline to both directly after intervention and 3 months after
Stroke Impact Scale
Time frame: change from baseline to both directly after intervention and 3 months after
Barthel Index
Time frame: change from baseline to both directly after intervention and 3 months after
Hospital Anxiety and Depression Scale
Time frame: change from baseline to both directly after intervention and 3 months after
Neurological Fatigue Index
Time frame: change from baseline to both directly after intervention and 3 months after
NEO-Fünf-Faktoren Inventar
Time frame: baseline
Situational Motivation Scale
Time frame: change from baseline to both directly after intervention and 3 months after
Berlin Social Support Scale
Time frame: change from baseline to both directly after intervention and 3 months after
Credibility/Expectancy Questionnaire
Time frame: change from baseline to both directly after intervention and 3 months after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ipsilesional stimulation and Contralesional stimulation in people with Chronic Stroke, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (Upper Extremity) (time frame: change from baseline to both directly after intervention and 3 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.