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

NCT01242956 | Terminated Phase 2 DMC

• 1 other identifier: CTC-A10-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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").

Conditions

Stroke; Upper Limb Paresis

Keywords

stroke; video-based training; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test

  Improvement of experimental group in standardized motor function test (Wolf Motor Function Test - WMFT) relative to control groups.

  31 +/-1 weeks

Secondary Outcomes (1)

• Quality of Life

  31 +/-1 weeks

Study Arms (2)

Verum group

EXPERIMENTAL

video-based training after stroke

Behavioral: verum group

Placebo group

PLACEBO COMPARATOR

non-video group

Behavioral: Placebo group

Interventions

verum group BEHAVIORAL

video-based training after stroke

Verum group

Placebo group BEHAVIORAL

non-video group

Placebo group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ferdinand Binkofski, Prof. Dr. med.

  Department of Neurology, Cognitive Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: September 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)