Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02331407
• Collaborator: Orentreich Family Foundation (Other), Mailman School of Public Health (Other)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 30.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Robotic arm therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot arm rehabilitation therapy Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.	Device: Robotic arm therapy; Training with the ReoGo device

Outcome Measures

Primary Outcome Measures

1. Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance [From baseline to within 1 week post-therapy]

   Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.

Secondary Outcome Measures

1. Fugl-Meyer (FM) Upper Extremity Motor Assessment [baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy]

   The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome.

2. Action Research Arm Test [baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy]

   The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Hemiparesis of the upper extremity

2. Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry

3. Age 18 years or older

4. Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.

Exclusion Criteria:

1. Inability to understand and/or follow instructions

2. Pain in shoulder or arm

3. Other neurological or musculoskeletal target organ disorder

4. Inability to give informed consent personally

5. Previous or current contracture of the upper extremity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia Univeristy, Neurological Institute	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• Orentreich Family Foundation
• Mailman School of Public Health

Investigators

• Principal Investigator: John Krakauer, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT02331407
• Other Study ID Numbers: AAAD3437
• First Posted: Jan 6, 2015
• Last Update Posted: May 7, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Recruitment Details	Patients with post-stroke arm paresis were recruited from June 2009 to May 2011

Arm/Group Title	Robot Arm Rehabilitation Therapy
Arm/Group Description	Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Robot Arm Rehabilitation Therapy
Arm/Group Description	Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Overall Participants	9
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	1 11.1%
Male	8 88.9%
Stroke Side (Count of Participants)
Right	2 22.2%
Left	7 77.8%

Outcome Measures

1. Primary Outcome

Title	Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance
Description	Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.
Time Frame	From baseline to within 1 week post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robot Arm Rehabilitation Therapy
Arm/Group Description	Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Measure Participants	9
Number [unitless]	-16.31

2. Secondary Outcome

Title	Fugl-Meyer (FM) Upper Extremity Motor Assessment
Description	The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome.
Time Frame	baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robot Arm Rehabilitation Therapy
Arm/Group Description	Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Measure Participants	9
Pretest 1: 3 weeks before baseline	30.3 (15.8)
Pretest 2: 1 week before baseline	32.8 (17.4)
Posttest 1: 1 week after therapy	36.0 (14.6)
Posttest 2: 3 weeks after therapy	38.3 (15.5)

3. Secondary Outcome

Title	Action Research Arm Test
Description	The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome.
Time Frame	baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Robot Arm Rehabilitation Therapy
Arm/Group Description	Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Measure Participants	9
Pretest 1: 3 weeks before baseline	19.6 (18.0)
Pretest 2: 1 week before baseline	21.3 (17.1)
Posttest 1: 1 week after therapy	23.7 (18.6)
Posttest 2: 3 weeks after therapy	25.0 (16.7)

Adverse Events

Arm/Group Title	Robot Arm Rehabilitation Therapy
Arm/Group Description	Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
All Cause Mortality
	Robot Arm Rehabilitation Therapy
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Serious Adverse Events
	Robot Arm Rehabilitation Therapy
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Robot Arm Rehabilitation Therapy
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

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.