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

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00223808
• Collaborator: (none)
• Enrollment: 71
• Locations: 4
• Arms: 3
• Duration (Months): 78
• Patients Per Site: 17.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disorders; Hemiplegia	Other: Robot-Low; Other: Robot-High; Other: Control	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot-Low low-dose mechanically-assisted upper limb therapy	Other: Robot-Low; 1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
Experimental: Robot-High high-dose mechanically-assisted upper limb therapy	Other: Robot-High; 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
Active Comparator: Control additional traditional therapy	Other: Control; 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot

Outcome Measures

Primary Outcome Measures

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

   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.

2. Fugl-Meyer Score Change at 6 Months [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.]

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

Secondary Outcome Measures

1. 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 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.

2. 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.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304-1290
2	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California	United States	90073
3	Michael E. DeBakey VA Medical Center (152)	Houston	Texas	United States	77030
4	Central Texas Veterans Health Care System	Temple	Texas	United States	76504

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Charles Burgar, MD, Central Texas Veterans Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00223808
• Other Study ID Numbers: B2695-I; NCT00038324
• First Posted: Sep 22, 2005
• Last Update Posted: Feb 17, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by US Department of Veterans Affairs: Rehabilitation; Robotics
• Additional relevant MeSH terms: Hemiplegia; Cerebrovascular Disorders

Study Results

Participant Flow

Recruitment Details	Enrollment: November 2002 - December 2004 Enrollment sites: Michael E. DeBakey VA Medical Center, Houston, TX; VA Greater Los Angeles Healthcare System, Los Angeles, CA; and VA Palo Alto Health Care System, Palo Alto, CA. Data analysis site: Central Texas Veterans Health Care System, Temple, TX.
Pre-assignment Detail	4 subjects excluded from group assignment due to medical conditions that precluded moderate-workload exercise.

Arm/Group Title	Robot-Low	Robot-High	Control
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy	Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy	Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
Period Title: Overall Study
STARTED	22	22	23
COMPLETED	19	17	18
NOT COMPLETED	3	5	5

Baseline Characteristics

Arm/Group Title	Robot-Low	Robot-High	Control	Total
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy	Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy	Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot	Total of all reporting groups
Overall Participants	22	22	23	67
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	16 72.7%	19 86.4%	10 43.5%	45 67.2%
>=65 years	6 27.3%	3 13.6%	13 56.5%	22 32.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.95 (8.34)	59.04 (9.30)	67.87 (12.56)	63.36 (10.75)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 4.5%	0 0%	1 1.5%
Male	22 100%	21 95.5%	23 100%	66 98.5%
Region of Enrollment (participants) [Number]
United States	22 100%	22 100%	23 100%	67 100%

Outcome Measures

1. Primary Outcome

Title	Fugl-Meyer Score Change Immediately Following Study Intervention.
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robot-Low	Robot-High	Control
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.	Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.	Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Measure Participants	19	17	18
Mean (Standard Error) [units on a scale]	6.8 (1.9)	14.4 (3.6)	14.0 (3.6)

2. Primary Outcome

Title	Fugl-Meyer Score Change at 6 Months
Description	Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

A total of 37 subjects returned for the 6-month follow-up evaluations.

Arm/Group Title	Robot-Low	Robot-High	Control
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.	Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.	Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Measure Participants	14	11	12
Mean (Standard Error) [units on a scale]	15.9 (3.5)	23.6 (5.8)	15.3 (4.9)

3. Secondary Outcome

Title	Change in FIM Score Immediately Following Study Intervention.
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robot-Low	Robot-High	Control
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.	Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.	Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Measure Participants	19	17	18
Mean (Standard Error) [units on a scale]	17.7 (1.9)	21.5 (2.1)	15.9 (1.5)

4. Secondary Outcome

Title	Change in FIM Score at 6-months
Description	Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63 .
Time Frame	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.

Outcome Measure Data

Analysis Population Description

A total of 37 subjects returned for the 6-month follow-up evaluations.

Arm/Group Title	Robot-Low	Robot-High	Control
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.	Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.	Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Measure Participants	14	11	12
Mean (Standard Error) [units on a scale]	24.2 (2.9)	27.5 (3.0)	26.8 (3.1)

Adverse Events

Arm/Group Title	Robot-Low		Robot-High		Control
Arm/Group Description	Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy		Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy		Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
All Cause Mortality
	Robot-Low		Robot-High		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Robot-Low		Robot-High		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Robot-Low		Robot-High		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/23 (0%)		0/22 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.