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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223808
• Other study ID #: B2695-I
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: January 3, 2014
• Start date: January 2002
• Est. completion date: July 2008

Study information

• Verified date: January 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Other known NCT identifiers

• NCT00038324

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Hemiplegia

Intervention

Other:
• Robot-Low
1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
• Robot-High
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
• Control
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Central Texas Veterans Health Care System	Temple	Texas
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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.	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.	No
Secondary	Change in FIM Score at 6-months	Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63	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.	No