Video-based Training for Rehabilitation of Upper Limb Functions After Stroke

September 22, 2015 updated by: RWTH Aachen University

Video-based Training for Rehabilitation of Upper Limb Functions After Stroke: a New Treatment Exploiting the Mirror Neuron System

The study hypothesizes superiority of the video-based training (observation combined with motor exercise, "video") over motor exercise alone ("non-video") and standard rehabilitation ("standard").

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The clinical study is a multicenter, open, randomized, controlled, paralleled group trial with three investigative arms. The study recruits at least 375 first stroke patients with certain motoric disabilities that are randomly assigned to either one experimental condition or one of two control conditions. Every individual patient participates for 31 (+/- 1) weeks in the trial (see fig. 1), the whole study is planned to last at least for 3 years. The recruitment and treatment of patients will last for 17 months during the trial. Patients undergo a baseline assessment for screening purposes and during the course of participation three further assessments of primary and secondary efficacy endpoints. These endpoints will refer to the degree of recovered objective and subjective physical abilities due to the experimental treatment in comparison to the control comparators. Studies' hypotheses claim that the experimental treatment will lead to effects on the motoric abilities superior the effects elicited by the control treatments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • RWTH Aachen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized patient: discharge from rehabilitation within the following week; outpatient: insult between 6 weeks and 2 years in the past (controlled via medical history).
  • Age between 30 and 80 years, since older patients could probably not exercise the stamina necessary for a participation throughout the whole time course of the treatment (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively).
  • First clinically evident stroke so that the patient has no history of stroke related trainings and treatments (controlled via medical history).
  • Ischemic cortical or subcortical lesions in middle cerebral artery territory resulting mainly in defined motoric impairments (controlled via medical history).
  • Upper limb paresis (controlled via standard neurological examination).
  • Minimal movement ability of the paretic limb (controlled by MRC index ≥2 and ≤4: hand extension against gravity at wrist = 20° and at metacarpophalangeal and interphalangeal joints of each of the fingers = 10°) to participate in the treatments' physical training tasks.
  • If medication is needed: stable concomitant medication (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively)
  • Signed informed consent to participate in the trial.

Exclusion Criteria:

  • Brain stem infarction. These lesion site results in further impairments that could interfere with treatment (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively).
  • Impaired level of consciousness that could prevent patient to understand and follow instructions throughout the intervention, and further result in inabilities to hold attentiveness and concentration to the treatment (controlled via standard neurological examination).
  • Severe aphasia that could prevent patient to understand and follow instruction throughout the intervention (controlled by administration of the Token test, TT, > 11 incorrect reactions).
  • Dementia that could lead to impaired abilities to follow instructions (controlled by administration of the Mini-Mental-State Examination, MMSE, score < 26).
  • Depression that could result in major difficulty of the patients motivational compliance to follow instructions and to participate in the interventions' tasks throughout the treatment (controlled by administration of the Beck Depression Inventory, BDI, score < 15).
  • Apraxia that could lead to impaired abilities to follow instructions (controlled by administration of the Florida Apraxia Screening Test, FAST, < 10 correct re-actions and/ or > 10 incorrect reactions).
  • Neglect that could lead to impaired abilities to participate in the treatments observational tasks (controlled by administration of the Albert's Neglect Test, > 1 line unchecked).
  • Severe psychiatric disorder, severe pulmonary or cardiovascular disease, or epilepsy that could lead to reduced abilities to participate in the treatments' task (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively).
  • Severe joint deformity of arthritic origin that could reduce the patients abilities in tasks demanding a functional physical execution thus resulting in the masking of possible training effects (controlled via standard neurological examination).
  • Motor problems not primarily unilateral or excessive pain in major affected limb that could reduce the patients abilities in tasks demanding a functional physical execution thus resulting in the masking of possible training effects (controlled via standard neurological examination).
  • Actual treatment with Botox or neuroleptics; no constant concomitant medication (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively).
  • Planned start of other rehabilitation therapies that might interfere with the trial treatment in the next eight weeks from time point of recruitment.
  • Insufficient knowledge of german language to understand and fill in the questionnaires (clinical judgement during standard neurological examination).
  • Residence more then 300 kilometres from participating centre, that would exacerbate the regular visits of the patient in the respective centre (controlled by questioning of the patient).
  • People who are accommodated in an institution by court or administrative order (controlled by questioning of the patient).
  • Any other illness or medical treatment or drug or narcotics misuse that could interfere with the assessment of the safety, tolerability and efficacy, e.g. current bone fractures of the stroke affected limb. (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively) .
  • Simultaneous participation in another (clinical) trial or interfering examination or participation in a study within 90 days prior to screening
  • People who are in a dependency / employment for the sponsor or investigator (controlled by questioning of the patient). .
  • Pregnancy or suspected pregnancy. Lack of safe contraceptive measures (see 5.4).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Verum group
video-based training after stroke
Behavioral: verum group
video-based training after stroke
PLACEBO_COMPARATOR: Placebo group
non-video group
Behavioral: Placebo group
non-video group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wolf Motor Function Test
Time Frame: 31 +/-1 weeks
Improvement of experimental group in standardized motor function test (Wolf Motor Function Test - WMFT) relative to control groups.
31 +/-1 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 31 +/-1 weeks
Quality of life related to improvement in motor function indices (Frenachay Arm Test - FAT) and autonomy (Stroke Impact Scale -SIS, Barthel-Index - BI, Modified Rankin Scale, Motor Activity Log - MAL)
31 +/-1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RWTH Aachen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ferdinand Binkofski, Prof. Dr. med., Department of Neurology, Cognitive Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTC-A10-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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