Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

NCT ID: NCT03947645

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2022-12-01

Brief Summary

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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

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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

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ipsilesional stimulation

Ipsilesional stimulation

Group Type EXPERIMENTAL

Ipsilesional stimulation

Intervention Type DEVICE

Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle

Contralesional stimulation

Contralesional stimulation

Group Type EXPERIMENTAL

Contralesional stimulation

Intervention Type DEVICE

Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Interventions

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Ipsilesional stimulation

Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle

Intervention Type DEVICE

Contralesional stimulation

Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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In-Tens

Identifier Type: -

Identifier Source: org_study_id

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