StrokeNCT00343304
Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke
A study testing Robot and Ergometer in people with Stroke, run by Burke Rehabilitation Hospital at 1 site in United States.
Trial summary
We will test whether robot driven, goal directed, trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer (monark). Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot and Ergometer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2006
- Phase
- Interventional
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a recent acute stroke in the last 4 weeks
- Patients with an upper extremity plegia (Medical Research Council [MRC] grade 2 or less at the shoulder joint),
- Patients or their next of kin (in the absence of their being able to) provide with a written informed consent.
- Aphasic alert patients provided they could follow simple directions given by verbal or gestural cues.
Who cannot join
- Patients with anterior or severe inferior shoulder subluxation (3 cms) of the plegic arm
- Patients without shoulder pain on passive range of 75 degrees forward flexion and 75 degrees abduction of the plegic arm
- Patients with trophic skin changes and significant edema (shoulder-hand syndrome)
- Patients with prior rotator cuff surgery, patients with bursitis and/or biceps tendonitis
- Patients who have suffered recent cardiac events (myocardial infarction, congestive cardiac failure, recent coronary artery bypass surgery)
- Patients who refuse to sign a written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Rehabilitation Hospital
White Plains, New York, 10605
About this study
We will test whether robot driven, goal directed, trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer (monark).
Read the detailed description
Upper extremity (UE) weakness post-stroke occurs in 70-80% of patients. By 3 months this complaint persists in 40% of patients, and by 6 months this complaint persists in a similar percentage of patients (1). Greater improvement in motor functional recovery was achieved in patients with intact sensation. Shoulder pain persisted in 20% of patients (2). Most of the arm recovery occurs in the initial 3 months post-stroke (2,3,4). The Copenhagen stroke study found 79% of patients with mild UE paresis achieving functional motor recovery compared to 18% of patients with severe UE paresis (4). Katrak P et al. found early shoulder shrug and synergistic hand movements to be useful bedside predictors of functional motor recovery of the UE (5). The initial grade of paresis (measured on admission in the hospital) is the most important predictor of motor recovery after stroke, with initial paralysis implying the worst prognosis for subsequent motor recovery (6). Perceptual inattention does impact upon UE action and functional recovery (7). The UE weakness and functional motor recovery lags behind lower extremity (LE) weakness and functional motor recovery because of the complexity of motor skills needed for daily living tasks.
Due to the persistence of upper extremity weakness, different rehabilitation techniques such as Constraint Induced (CI) (8,9,10) and robotic (11,12,13) therapies were developed to help with meaningful functional motor recovery in the paretic arm (unilateral arm training). Both of these forced-use interventions focus on the paretic arm only. The main drawback of the CI therapy is that subjects need to have some degree of voluntary movement both at the wrist and the digits. Bilateral arm training with rhythmic clueing (BATRAC) has been used in chronic stroke patients and has been found to improve functional motor performance in the paretic UE (14). The authors in a recent paper showed BATRAC inducing reorganization in contraleisonal motor networks based on functional MRI (15). Facilitation of paretic arm movement by the non-paretic arm (bimanual movement) is thought to be superior to individual paretic arm movement, which indicates both arms to be a coordinated brain unit (16). Richards L et al., in their review article (17) and Vander Lee J et al., in their meta-analysis of randomized stroke trials (18) on therapeutic interventions to improve UE function, found extensive practice to be the most important factor irrespective of the type of intervention instituted. Early repetitive sensorimotor stimulation of the arm results in long-lasting functional motor recovery (19).
The overall goal of this study is to determine whether bilateral arm training with upper body ergometer is as or more effective in upper extremity functional recovery than unilateral arm training with robot in patients with a recent ischemic and hemorrhagic stroke.
- Conditions
- Stroke
- Being tested
- Robot, Ergometer
- Keywords
- Stroke.Robot.Ergometer.Group OT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotDevice
ErgometerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM™)
Secondary outcomes (5)
The Fugl-Meyer Assessment (FMA) scale
Motor Status Scale (MSS)
Medical Research Council (MRC)
Motor Power Scale (MPS) Action Research Arm Test (ARAT)
Modified Ashworth scale (MAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startApr 2005
- Study completionMay 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Burke Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Meheroz H Rabadi, MD, MRCPI, Principal investigator, Burke Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343304
- Sponsor's protocol ID
- BRC-357
- Status last verified
- Apr 2005
- First submitted
- 20 Jun 2006
- Last updated
- 22 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke
- ClinicalTrials.gov ID
- NCT00343304
- Acronym / sponsor ID
- BRC-357
- Conditions
- Stroke
- Keywords
- Stroke.Robot.Ergometer.Group OT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Burke Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- May 2006
- First posted
- 22 Jun 2006 (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.
We will test whether robot driven, goal directed, trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer (monark).
Detailed description
Upper extremity (UE) weakness post-stroke occurs in 70-80% of patients. By 3 months this complaint persists in 40% of patients, and by 6 months this complaint persists in a similar percentage of patients (1). Greater improvement in motor functional recovery was achieved in patients with intact sensation. Shoulder pain persisted in 20% of patients (2). Most of the arm recovery occurs in the initial 3 months post-stroke (2,3,4). The Copenhagen stroke study found 79% of patients with mild UE paresis achieving functional motor recovery compared to 18% of patients with severe UE paresis (4). Katrak P et al. found early shoulder shrug and synergistic hand movements to be useful bedside predictors of functional motor recovery of the UE (5). The initial grade of paresis (measured on admission in the hospital) is the most important predictor of motor recovery after stroke, with initial paralysis implying the worst prognosis for subsequent motor recovery (6). Perceptual inattention does impact upon UE action and functional recovery (7). The UE weakness and functional motor recovery lags behind lower extremity (LE) weakness and functional motor recovery because of the complexity of motor skills needed for daily living tasks.
Due to the persistence of upper extremity weakness, different rehabilitation techniques such as Constraint Induced (CI) (8,9,10) and robotic (11,12,13) therapies were developed to help with meaningful functional motor recovery in the paretic arm (unilateral arm training). Both of these forced-use interventions focus on the paretic arm only. The main drawback of the CI therapy is that subjects need to have some degree of voluntary movement both at the wrist and the digits. Bilateral arm training with rhythmic clueing (BATRAC) has been used in chronic stroke patients and has been found to improve functional motor performance in the paretic UE (14). The authors in a recent paper showed BATRAC inducing reorganization in contraleisonal motor networks based on functional MRI (15). Facilitation of paretic arm movement by the non-paretic arm (bimanual movement) is thought to be superior to individual paretic arm movement, which indicates both arms to be a coordinated brain unit (16). Richards L et al., in their review article (17) and Vander Lee J et al., in their meta-analysis of randomized stroke trials (18) on therapeutic interventions to improve UE function, found extensive practice to be the most important factor irrespective of the type of intervention instituted. Early repetitive sensorimotor stimulation of the arm results in long-lasting functional motor recovery (19).
The overall goal of this study is to determine whether bilateral arm training with upper body ergometer is as or more effective in upper extremity functional recovery than unilateral arm training with robot in patients with a recent ischemic and hemorrhagic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a recent acute stroke in the last 4 weeks
- Patients with an upper extremity plegia (Medical Research Council [MRC] grade 2 or less at the shoulder joint),
- Patients or their next of kin (in the absence of their being able to) provide with a written informed consent.
- Aphasic alert patients provided they could follow simple directions given by verbal or gestural cues.
Key exclusion criteria (6 listed)
- Patients with anterior or severe inferior shoulder subluxation (3 cms) of the plegic arm
- Patients without shoulder pain on passive range of 75 degrees forward flexion and 75 degrees abduction of the plegic arm
- Patients with trophic skin changes and significant edema (shoulder-hand syndrome)
- Patients with prior rotator cuff surgery, patients with bursitis and/or biceps tendonitis
- Patients who have suffered recent cardiac events (myocardial infarction, congestive cardiac failure, recent coronary artery bypass surgery)
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 |
|---|---|---|
| Robot | Device | – |
| Ergometer | Device | – |
Primary outcome
Functional Independence Measure (FIM™)
5 secondary outcomes
The Fugl-Meyer Assessment (FMA) scale
Motor Status Scale (MSS)
Medical Research Council (MRC)
Motor Power Scale (MPS) Action Research Arm Test (ARAT)
Modified Ashworth scale (MAS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2006.
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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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.
Meheroz H Rabadi, MD, MRCPI principal investigator
Burke Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot and Ergometer in people with Stroke, run by Burke Rehabilitation Hospital at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jun 2006. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Independence Measure (FIM™). 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 22 Jun 2006.