Back to resultsThe General Use of Robots in Stroke Recovery
Primary Purpose
Stroke
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMT Robotic Arm therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebrovascular Accident, Cerebral stroke, CVA, robotic therapy, upper extremity recovery, kinematic training
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- Cognitive function sufficient enough to understand experiments and follow instructions
- Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion Criteria:
- Prior experience with robotic arm therapy
- Fixed contraction of the affected limb
- Complete flaccid paralysis of the affected limb
Sites / Locations
- Feinstein Institute for Medical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
IMT Robotic Arm Therapy: Aim training
IMT Robotic Arm Therapy: Smoothness Training
IMT Robotic Arm Therapy: Impairment training
IMT Robotic Arm Therapy: Functional training
Arm Description
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.
Outcomes
Primary Outcome Measures
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Secondary Outcome Measures
Change from baseline in Kinematic Data
Kinematic Data recorded during therapy with IMT robots
Change from baseline in Fugl Meyer Sensation Scale
Change from baseline in Fugl Meyer Proprioception Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726660
Brief Title
The General Use of Robots in Stroke Recovery
Official Title
Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unfunded
Study Start Date
February 2012 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Cerebrovascular Accident, Cerebral stroke, CVA, robotic therapy, upper extremity recovery, kinematic training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT Robotic Arm Therapy: Aim training
Arm Type
Experimental
Arm Description
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
Arm Title
IMT Robotic Arm Therapy: Smoothness Training
Arm Type
Experimental
Arm Description
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
Arm Title
IMT Robotic Arm Therapy: Impairment training
Arm Type
Experimental
Arm Description
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.
Arm Title
IMT Robotic Arm Therapy: Functional training
Arm Type
Experimental
Arm Description
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.
Intervention Type
Device
Intervention Name(s)
IMT Robotic Arm therapy
Intervention Description
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
Primary Outcome Measure Information:
Title
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Time Frame
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary Outcome Measure Information:
Title
Change from baseline in Kinematic Data
Description
Kinematic Data recorded during therapy with IMT robots
Time Frame
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Title
Change from baseline in Fugl Meyer Sensation Scale
Time Frame
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Title
Change from baseline in Fugl Meyer Proprioception Scale
Time Frame
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
Cognitive function sufficient enough to understand experiments and follow instructions
Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion Criteria:
Prior experience with robotic arm therapy
Fixed contraction of the affected limb
Complete flaccid paralysis of the affected limb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce T Volpe, MD
Organizational Affiliation
Feinstein Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15314537
Citation
Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.
Results Reference
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The General Use of Robots in Stroke Recovery
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