StrokeNCT05262699
Crossmodal Learning in Therapeutic Processes (Task 2-1)
A study testing Vibro-tactile stimulation in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Vibro-tactile stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2021to Dec 2024
- 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
- Ischemic stroke according to ICD 10 I61-I69
- Deficit still existing (Rankin score of at least 1 at inclusion)
- Age >= 18, <=80
- Existing declaration of consent
Who cannot join
- Pregnancy
- Lacking capacity for consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf, Neurologie
Hamburg, 20246
About this study
Official title: SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.
- Conditions
- Stroke
- Being tested
- Vibro-tactile stimulation, Placebo Control
- Keywords
- Vibro-tactile stimulation, Neurorehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibro-tactile stimulationDevice
Vibro-tactile stimulation will be administered to the fingers of the participants via C3 tactors (diameter: 2.03 cm, height: 0.64 cm, operating frequency: 180-320 Hz, see https://www.eaiinfo.com/tactor-info/). Vibro-tactile stimulation will be triggered by force-sensing resistors (TEA CAPTIV T-SENS FSR, see https://www.teaergo.com/products/tea-captiv-t-sens-fsr/).
Placebo ControlOther
Devices mounted, no stimulation
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | During motor training participants in the stimulation arm receive vibro-tactile feedback applied to their fingers when touching an object as measured by force-sensing resistors mounted to the fingertips. Receives: Device: Vibro-tactile stimulation |
| Control | Placebo comparator | The control group receives the same motor training with the same derives (force-sensing resistors, vibro-tactile stimulators) mounted to the hands but receives no stimulation. Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores may range from 0-57 points, with higher points indicating better performance.
Measured: One day before (baseline) and one day after seven days of motor training
Change from baseline in Nine-hole peg Test (NHPT)
A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible.
Measured: One day before (baseline) and one day after seven days of motor training
Secondary outcomes (4)
Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)
The section motor function of upper limb is one of five domains, a three-point scale is used for rating performance as 0=cannot perform, 1=performs partially and 2=performs fully, max. possible score: 66 points.
Measured: One day before (baseline) and one day after seven days of motor training
Change from baseline in Stroke Impact Scale (SIS)
Measurement of subjective stroke-specific health status, 64 items in eight domains, domain scores range between 0-100, with higher scores represent better health status.
Measured: One day before (baseline) and one day after seven days of motor training
Change from baseline in National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale, NIHSS, is a score system to quantify the impairment caused by a stroke. The sum of the values from the investigations results in a maximum of 42 points. The higher the score, the more extensive the stroke.
Measured: One day before (baseline) and one day after seven days of motor training
Change from baseline in Modified Rankin Scale (mRS)
The modified Rankin scale (MRS) is a standardized measure that describes the extent of disability after a stroke. It ranges from 0 (no symptoms) to 6 (death due to stroke).
Measured: One day before (baseline) and one day after seven days of motor training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start14 Apr 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Unability to include participants during Covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, National Natural Science Foundation of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262699
- Sponsor's protocol ID
- SFB TRR 169/A3 (2-1)
- Status last verified
- May 2023
- First submitted
- 5 Feb 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is planned after main publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)
- ClinicalTrials.gov ID
- NCT05262699
- Acronym / sponsor ID
- SFB TRR 169/A3 (2-1)
- Conditions
- Stroke
- Keywords
- Vibro-tactile stimulation, Neurorehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Unability to include participants during Covid pandemic
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Research Foundation, National Natural Science Foundation of China
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (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.
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Vibro-tactile stimulationDuring motor training participants in the stimulation arm receive vibro-tactile feedback applied to their fingers when touching an object as measured by force-sensing resistors mounted to the fingertips. |
| Control | Placebo comparator | Other: Placebo ControlThe control group receives the same motor training with the same derives (force-sensing resistors, vibro-tactile stimulators) mounted to the hands but receives no stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke according to ICD 10 I61-I69
- Deficit still existing (Rankin score of at least 1 at inclusion)
- Age >= 18, <=80
- Existing declaration of consent
Key exclusion criteria (2 listed)
- Pregnancy
- Lacking capacity for consent
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 |
|---|---|---|
| Vibro-tactile stimulationVibro-tactile stimulation will be administered to the fingers of the participants via C3 tactors (diameter: 2.03 cm, height: 0.64 cm, operating frequency: 180-320 Hz, see https://www.eaiinfo.com/tactor-info/). Vibro-tactile stimulation will be triggered by force-sensing resistors (TEA CAPTIV T-SENS FSR, see https://www.teaergo.com/products/tea-captiv-t-sens-fsr/). | Device | Stimulation |
| Placebo ControlDevices mounted, no stimulation | Other | Control |
Primary outcome
Change from baseline in Action Research Arm Test (ARAT)
Time frame: One day before (baseline) and one day after seven days of motor training
The Action Research Arm Test (ARAT) is a 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores may range from 0-57 points, with higher points indicating better performance.
Change from baseline in Nine-hole peg Test (NHPT)
Time frame: One day before (baseline) and one day after seven days of motor training
A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible.
4 secondary outcomes
Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time frame: One day before (baseline) and one day after seven days of motor training
Change from baseline in Stroke Impact Scale (SIS)
Time frame: One day before (baseline) and one day after seven days of motor training
Change from baseline in National Institutes of Health Stroke Scale (NIHSS)
Time frame: One day before (baseline) and one day after seven days of motor training
Change from baseline in Modified Rankin Scale (mRS)
Time frame: One day before (baseline) and one day after seven days of motor training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: Yes. Data sharing is planned after main publication of results.
Related trials for Stroke
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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 Vibro-tactile stimulation in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf 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 4 inclusion and 2 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: paused, as of the sponsor's last update on 23 May 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change from baseline in Action Research Arm Test (ARAT) (time frame: One day before (baseline) and one day after seven days of motor training). The study lists 2 primary outcomes in all. 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 23 May 2023.