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

NCT00223808 | Completed Phase 3 Results

• 1 other identifier: B2695-I
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cerebrovascular Disorders; Hemiplegia

Keywords

Rehabilitation; Robotics

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• Fugl-Meyer Score Change at 6 Months

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

  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)

• Change in FIM Score Immediately Following Study Intervention.

  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.

• Change in FIM Score at 6-months

  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.

Study Arms (3)

Robot-Low

EXPERIMENTAL

low-dose mechanically-assisted upper limb therapy

Other: Robot-Low

Robot-High

EXPERIMENTAL

high-dose mechanically-assisted upper limb therapy

Other: Robot-High

Control

ACTIVE COMPARATOR

additional traditional therapy

Other: Control

Interventions

Robot-Low OTHER

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

Robot-Low

Robot-High OTHER

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

Robot-High

Control OTHER

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

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to follow instructions; medically unstable.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (4)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Central Texas Veterans Health Care System

Temple, Texas, 76504, United States

Location

Related Publications (1)

• 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.

  PMID: 21674393 RESULT

MeSH Terms

Conditions

Cerebrovascular Disorders; Hemiplegia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations include the relatively small number of subjects in each group and the variation in severity level across subjects. Subjects at the Houston site were enrolled earlier after stroke than in the LA site and the Palo Alto site.

Results Point of Contact

• Title: Charles Burgar, MD
• Organization: CTVHCS

charles.burgar1@va.gov

254/743-0085

Study Officials

• Charles Burgar, MD

  Central Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 17, 2014
• Results First Posted: February 17, 2014

Record last verified: 2014-01

Locations

US (4)