Evaluation of Robotic Arm Rehabilitation in Stroke Patients

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00333983
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Robotic Upper Extremity Neurorehabilitation; Other: Traditional Upper Extremity Exercise Group	N/A

Detailed Description

A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Robotic Arm Rehabilitation in Stroke Patients
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Robot Exercise Group	Device: Robotic Upper Extremity Neurorehabilitation; Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
Active Comparator: Arm 2 Traditional Upper Extremity Exercise Group	Other: Traditional Upper Extremity Exercise Group; Upper extremity stretching, skateboard reaching activities, and arm ergometer

Outcome Measures

Primary Outcome Measures

1. Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment [Baseline to Final Training (6 weeks)]

   The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses

• Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients

• A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Exclusion Criteria:

• Subjects unable to give informed consent

• Serious complicating medical illness

• Contracture or orthopedic problems limiting the range of joint movement in the study arm

• Visual loss

• Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients

• Botox treatment within 3 months of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Maryland Health Care System, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Christopher Bever, MD, VA Maryland Health Care System, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00333983
• Other Study ID Numbers: B3833-R
• First Posted: Jun 6, 2006
• Last Update Posted: Mar 20, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Recruitment Details	147 community-dwelling adults with a diagnosis of chronic stroke were referred for study criteria screening by local VA stroke clinics and PT/OT clinicians. Community study advertisements and flyers were also utulized during this recruitment period that started October 2006 and ended December 2009.
Pre-assignment Detail	Participants were excluded prior to randomization if they did not meet inclusion/exclusion criteria. Some candidates declined after learning of the study length and schedule committment.

Arm/Group Title	Planar Robot	Planar + Vertical Robot	Intensive Conventional Exercise
Arm/Group Description	Robot-assisted planar reaching x 60 minutes	Robot-assisted planar and robot-assisted vertical reaching x 60 minutes	Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
Period Title: Overall Study
STARTED	20	21	21
COMPLETED	17	16	19
NOT COMPLETED	3	5	2

Baseline Characteristics

Arm/Group Title	Planar Robot	Planar + Vertical Robot	Intensive Conventional Exercise	Total
Arm/Group Description	Robot-assisted planar reaching x 60 minutes.	Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.	Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.	Total of all reporting groups
Overall Participants	20	21	21	62
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	16 80%	17 81%	19 90.5%	52 83.9%
>=65 years	4 20%	4 19%	2 9.5%	10 16.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (12)	60 (13)	56 (6.3)	57 (11)
Sex: Female, Male (Count of Participants)
Female	8 40%	9 42.9%	11 52.4%	28 45.2%
Male	12 60%	12 57.1%	10 47.6%	34 54.8%
Region of Enrollment (participants) [Number]
United States	20 100%	21 100%	21 100%	62 100%
Fugl-Meyer Upper Extremity Motor Assessment (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.3 (14.7)	16.5 (10.6)	18.2 (12.5)	18.0 (12.5)

Outcome Measures

1. Primary Outcome

Title	Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
Description	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.
Time Frame	Baseline to Final Training (6 weeks)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.

Arm/Group Title	Planar Robot	Planar + Vertical	Intensive Conventional Exercise
Arm/Group Description	Planar Robot Exercise x 60 minutes.	Planar + Vertical Robot Exercise x 60 minutes.	Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
Measure Participants	20	21	21
Mean (Standard Deviation) [units on a scale]	3.27 (3.27)	2.51 (3.33)	1.82 (4.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Planar Robot, Planar + Vertical, Intensive Conventional Exercise
	Comments	An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.025
	Comments	P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.
Arm/Group Title	Planar Robot		Planar + Vertical Robot		Intensive Conventional Exercise
Arm/Group Description	Planar Robot Exercise Group		Planar + Vertical Robot Exercise Group		Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
All Cause Mortality
	Planar Robot		Planar + Vertical Robot		Intensive Conventional Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Planar Robot		Planar + Vertical Robot		Intensive Conventional Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Planar Robot		Planar + Vertical Robot		Intensive Conventional Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		1/21 (4.8%)		1/21 (4.8%)
General disorders
Hospitalization	2/20 (10%)	2	1/21 (4.8%)	1	0/21 (0%)	0
Musculoskeletal and connective tissue disorders
Shoulder pain	0/20 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1

Limitations/Caveats

This study was terminated early with the current number of subjects analyzed. A midstudy futility analysis showed a need for 99 participants per group to determine signifcance between the robotic training over the intensive conventional exercise.

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.