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Cerebrovascular DisordersPhase 3NCT00223808

Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

A Phase 3 study testing Robot-Low and Robot-High in people with Cerebrovascular Disorders and Hemiplegia, run by US Department of Veterans Affairs at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Cerebrovascular Disorders, Hemiplegia
What is being tested?
Robot-Low and Robot-High
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
4 sitesUnited States
Study dates
Jan 2002to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.

Who cannot join

  • Unable to follow instructions; medically unstable.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Michael E. DeBakey VA Medical Center (152)

    Houston, Texas, 77030

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1290

  • Central Texas Veterans Health Care System

    Temple, Texas, 76504

  • VA Greater Los Angeles Healthcare System, West LA

    West Los Angeles, California, 90073

Other trials in United States

About this study

The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.

Read the detailed description

This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention. Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR\&DC), and the Central Texas Veterans Health Care System (CTVHCS). CTVHCS serves as the coordinating site. The RR\&DC provides training and technical assistance for the other sites. Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups. Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Group 2 receives a total of 2 hours/day of robot-assisted therapy. Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.

Being tested
Robot-Low, Robot-High, Control
Keywords
Rehabilitation, Robotics
Medical subject headings
Cerebrovascular Disorders, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-LowOther

    1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy

  • Robot-HighOther

    2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy

  • ControlOther

    1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot

Study groups in NCT00223808
Study groupRoleWhat they receive
Robot-LowExperimentallow-dose mechanically-assisted upper limb therapy
Receives: Other: Robot-Low
Robot-HighExperimentalhigh-dose mechanically-assisted upper limb therapy
Receives: Other: Robot-High
ControlActive comparatoradditional traditional therapy
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Score Change Immediately Following Study Intervention.

    Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.

    Measured: After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.

  2. Fugl-Meyer Score Change at 6 Months

    Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.

    Measured: FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.

Secondary outcomes (2)

  1. Change in FIM Score Immediately Following Study Intervention.

    Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.

    Measured: After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.

  2. Change in FIM Score at 6-months

    Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63

    .

    Measured: Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJan 2002
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00223808
Sponsor's protocol ID
B2695-I
Status last verified
Jan 2014
First submitted
14 Sep 2005
Last updated
17 Feb 2014
Data monitoring committee
No

Publications

  • Burgar CG, Lum PS, Scremin AM, Garber SL, Van der Loos HF, Kenney D, Shor P. Robot-assisted upper-limb therapy in acute rehabilitation setting following stroke: Department of Veterans Affairs multisite clinical trial. J Rehabil Res Dev. 2011;48(4):445-58. doi: 10.1682/jrrd.2010.04.0062.

    PubMed 21674393

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Robot-Low and Robot-High in people with Cerebrovascular Disorders and Hemiplegia, run by US Department of Veterans Affairs at 4 sites 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 1 inclusion and 1 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 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fugl-Meyer Score Change Immediately Following Study Intervention. (time frame: After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00223808, which also lists 1 linked publication.

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 17 Feb 2014.

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