Extension of the MIME Robotic System for Stroke Rehabilitation

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00995774
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Impaired Upper Extremity Function	Device: robotic therapy; Other: conventional functional training; Device: robotic therapy; Other: conventional functional training	Phase 2

Detailed Description

Research Design:

We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy.

Methodology:

In the first year of the study, we will develop a robotic system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken before training and immediately after training.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Extension of the MIME Robotic System for Stroke Rehabilitation
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robotic then Conventional robotic arm therapy first, conventional therapy second	Device: robotic therapy; 12 sessions of robot therapy for arm and hand function; Other: conventional functional training; 12 sessions of conventional therapy for the arm and hand from a physical therapist
Experimental: Conventional then Robotic conventional therapy first, robotic therapy second	Device: robotic therapy; 12 sessions of robot therapy for arm and hand function; Other: conventional functional training; 12 sessions of conventional therapy for the arm and hand from a physical therapist

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Test of Motor Function [before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2]

   This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.

Secondary Outcome Measures

1. Action Research Arm Test [before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2]

   This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.

2. A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT). [pre-treatment, post treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study;

• trace ability to move the wrist and fingers in extension;

• voluntary shoulder elevation to approximately 45 deg;

• be between the ages of 21 and 90.

Exclusion Criteria:

• Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988);

• have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols;

• have an upper extremity injury or conditions prior to stroke that could limit participation;

• have severe hemispatial neglect.

• have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and

• have severe sensory loss.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, DC	Washington	District of Columbia	United States	20422

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Peter S. Lum, PhD, VA Medical Center, DC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00995774
• Other Study ID Numbers: B4719-R
• First Posted: Oct 15, 2009
• Last Update Posted: Sep 20, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by US Department of Veterans Affairs: stroke; function; arm; hand; robotic; therapy; motor; movement; treatment
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Recruitment Details	Recruitment was through "word of mouth" with therapists at the outpatient clinics of the DC Veterans Affair Medical Center and the MedStar National Rehabilitation Hospital. Recruitment took place approximately between 9/2010 and 3/2012.
Pre-assignment Detail	Fourteen individuals were recruited. One subject was excluded due to a prior orthopedic injury and another subject did not meet the Folstein Mini-Mental State Examination criterion. Two subjects completed the protocol up through the initial training period and the washout period, but did not return for the second therapy block.

Arm/Group Title	Robotic Then Conventional	Conventional Then Robotic
Arm/Group Description	12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist	12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Period Title: Training Period 1
STARTED	7	5
COMPLETED	7	5
NOT COMPLETED	0	0
Period Title: Training Period 1
STARTED	7	5
COMPLETED	7	5
NOT COMPLETED	0	0
Period Title: Training Period 1
STARTED	7	5
COMPLETED	5	5
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Robotic Then Conventional	Conventional Then Robotic	Total
Arm/Group Description	12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist	12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy	Total of all reporting groups
Overall Participants	7	5	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 57.1%	4 80%	8 66.7%
>=65 years	3 42.9%	1 20%	4 33.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.7 (10.8)	57.8 (16.3)	57.7 (12.2)
Sex: Female, Male (Count of Participants)
Female	3 42.9%	0 0%	3 25%
Male	4 57.1%	5 100%	9 75%
Region of Enrollment (Count of Participants)
United States	7 100%	5 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Fugl-Meyer Test of Motor Function
Description	This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.
Time Frame	before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robotic Then Conventional	Conventional Then Robotic
Arm/Group Description	12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist	12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Measure Participants	7	5
Change from beginning to end of training period 1	1.9 (4.6)	.8 (2.9)
Change from beginning to end of washout period	1.3 (4.4)	.8 (3.9)
Change from beginning to end of training period 2	1.6 (3.6)	1.6 (2.3)

2. Secondary Outcome

Title	Action Research Arm Test
Description	This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.
Time Frame	before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robotic Then Conventional	Conventional Then Robotic
Arm/Group Description	12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist	12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Measure Participants	7	5
Change from beginning to end of training period 1	4.6 (3.5)	-.2 (1.1)
Change from beginning to end of washout period	.4 (2.9)	0 (1.6)
Change from beginning to end of training period 2	-2 (5.9)	1.4 (3.0)

3. Secondary Outcome

Title	A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).
Time Frame	pre-treatment, post treatment

Outcome Measure Data

Analysis Population Description

Data initially collected but could not interpret results due to a lack of resources and incomplete data analysis. No further staff, tools, or information is available to report conclusions.

Arm/Group Title	Robotic Then Conventional	Conventional Then Robotic
Arm/Group Description	12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist	12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Measure Participants	0	0

Adverse Events

Arm/Group Title	Robotic Then Conventional		Conventional Then Robotic
Arm/Group Description	12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist		12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
All Cause Mortality
	Robotic Then Conventional		Conventional Then Robotic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Robotic Then Conventional		Conventional Then Robotic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Robotic Then Conventional		Conventional Then Robotic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)

Limitations/Caveats

The limited therapy hours could mask potential gains that would have been made with additional therapy. Due to the small sample size, these results need to be confirmed in a larger scale study using a parallel study design.

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.