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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01242956
• Date of registration: 16/11/2010
• Primary sponsor: RWTH Aachen University
• Public title: Video-based Training for Rehabilitation of Upper Limb Functions After Stroke
• Scientific title: Video-based Training for Rehabilitation of Upper Limb Functions After Stroke: a New Treatment Exploiting the Mirror Neuron System
• Date of first enrolment: September 2011
• Target sample size: 400
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01242956
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Ferdinand Binkofski, Prof.

• Name: Denis Ertelt, Dr. Dipl.-Psych.

• Name: Ferdinand Binkofski, Prof. Dr. med.
• Affiliation: Department of Neurology, Cognitive Neurology

Key inclusion & exclusion criteria

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).



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Upper Limb Paresis

Intervention(s)

Behavioral: Placebo group

Behavioral: verum group

Primary Outcome(s)

Wolf Motor Function Test [Time Frame: 31 +/-1 weeks]

Secondary Outcome(s)

Quality of Life [Time Frame: 31 +/-1 weeks]

Secondary ID(s)

CTC-A10-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors