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Table 1 Inclusion and exclusion criteria

From: Observation and execution of upper-limb movements as a tool for rehabilitation of motor deficits in paretic stroke patients: protocol of a randomized clinical trial

Inclusion criteria

Patients that are both psychically and physically eligible, with good general state of health and nutritional condition for experimental treatment both in the intensity and duration planned in the presented trial (decided by the investigator).

Hospitalized patient: discharge from rehabilitation within the following seven days (patient's data in the respective clinic)

Insult at least 4 weeks in the past, hemorrhagic stroke at least 6 month in the past (controlled via medical history, patient's data in the respective clinic).

First clinically evident stroke so that the patient has no history of stroke related trainings and treatments (controlled via medical history, patient's data in the respective clinic, and note from the general practitioner from outpatients, respectively).

Ischemic cortical or subcortical lesions in middle cerebral artery territory or brain stem infarction resulting mainly in defined motor impairments (controlled via medical history, patient's data in the respective clinic, and note from the general practitioner from outpatients, respectively).

Primarily motor symptoms with also primarily unilateral upper limb paresis (controlled by 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 any, only minimal aphasic symptoms allowing for understanding and following instructions during test administration and treatment (controlled by administration of the Token test ≤ 21 incorrect reactions).

If medication is needed: concomitant medication with effects on the motor system, vigilance and/or cardiovascular system will be kept unchanged throughout of the participation in the study (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively; as well as by questioning the patient during the weekly telephone calls and the assessments throughout the training phase).

Signed informed consent to participate in the trial.

EU-citizen for legal aspects of participation.

A DVD-Player is either in possession of the participant or is lent to him by relatives or friends to allow participant to conduct the treatment at home.

Exclusion criteria

Impaired level of consciousness that could prevent patient to understand and follow instructions throughout the intervention, and further result in inability to hold attentiveness and concentration to the treatment (controlled via standard neurological examination, subjective impression of the investigator during administration of test inventory – i.e. patient is unable to understand and/or follow instructions).

Severe untreated 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). If any of the referred diseases is treated with allowed stable medication, patient may not be excluded from study participation.

Severe joint deformity of arthritic origin or chronic pain that could reduce significantly the patient's abilities to perform tasks that demand a functional physical execution, thus resulting in the masking of expected training effects (controlled via standard neurological examination).

Motor problems not primarily unilateral or excessive pain in major affected limb that could reduce the patient's abilities in tasks requiring a functional physical execution, thus resulting in the masking of expected training effects (controlled via standard neurological examination).

Dementia symptoms that could prevail over the administration of test inventories and treatment (controlled by administration of the Mini-Mental-State Examination, MMSE, score ≤ 22).

Depressive symptoms that could result in major difficulty of the patient's 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 ≥ 18).

Apraxic symptoms that could lead to impaired abilities to follow instructions (controlled by administration of the Florida Apraxia Screening Test, FAST, ≤ 9 correct reactions).

Neglect symptoms that could lead to impaired abilities to participate in the treatments observational tasks (controlled by administration of the Albert’s Neglect Test, ANT, minimal 2 lines unchecked).

Actual neuroleptic treatment for psychiatric reasons; no constant concomitant medication (controlled via discharge letter from hospitalized patients, and note from the general practitioner from outpatients, respectively).

Planned, but not actual treatment with psychotropic and/or antiepileptic medication or, if already in treatment, change of dose of the referred medications during the phase between the screening and post-trial assessments (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 judgment during standard neurological examination).

Residence more than 300 kilometers from participating center that would exacerbate the regular visits of the patient in the respective center (controlled by questioning of the patient).

Persons who are accommodated in an institution by court or administrative order (controlled by questioning of the patient).

Any other medically untreated 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).

Biological age <30.

Pregnancy or suspected pregnancy. Lack of safe contraceptive measures.