StrokePhase 2NCT01242956
Video-based Training for Rehabilitation of Upper Limb Functions After Stroke
A Phase 2 study testing verum group in people with Stroke and Upper Limb Paresis, run by RWTH Aachen University at 1 site in Germany.
Trial 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"). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Upper Limb Paresis
- What is being tested?
- verum group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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").
Read the 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.
- Conditions
- Stroke, Upper Limb Paresis
- Being tested
- verum group, Placebo group
- Keywords
- stroke, video-based training, rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verum groupBehavioural
video-based training after stroke
Placebo groupBehavioural
non-video group
| Study group | Role | What they receive |
|---|---|---|
| Verum group | Experimental | video-based training after stroke Receives: Behavioral: verum group |
| Placebo group | Placebo comparator | non-video group Receives: Behavioral: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Improvement of experimental group in standardized motor function test (Wolf Motor Function Test - WMFT) relative to control groups.
Measured: 31 +/-1 weeks
Secondary outcomes (1)
Quality of Life
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)
Measured: 31 +/-1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startSep 2011
- Primary completionNov 2014
- Study completionSep 2015
Why it stopped: Problem to recruit sufficient patient number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferdinand Binkofski, Prof. Dr. med., Principal investigator, Department of Neurology, Cognitive Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242956
- Sponsor's protocol ID
- CTC-A10-001
- Status last verified
- Sep 2015
- First submitted
- 16 Nov 2010
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based Training for Rehabilitation of Upper Limb Functions After Stroke: a New Treatment Exploiting the Mirror Neuron System
- ClinicalTrials.gov ID
- NCT01242956
- Acronym / sponsor ID
- CTC-A10-001
- Conditions
- Stroke, Upper Limb Paresis
- Keywords
- stroke, video-based training, rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problem to recruit sufficient patient number
- Enrolment
- 100 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum group | Experimental | Behavioral: verum groupvideo-based training after stroke |
| Placebo group | Placebo comparator | Behavioral: Placebo groupnon-video group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verum groupvideo-based training after stroke | Behavioural | Verum group |
| Placebo groupnon-video group | Behavioural | Placebo group |
Primary outcome
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.
1 secondary outcome
Quality of Life
Time frame: 31 +/-1 weeks
Results and safety
The study was stopped early (reason given: Problem to recruit sufficient patient number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinand Binkofski, Prof. Dr. med. principal investigator
Department of Neurology, Cognitive Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing verum group in people with Stroke and Upper Limb Paresis, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Problem to recruit sufficient patient number). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: 31 +/-1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.