Robot Therapy for Rehabilitation of Hand Movement After Stroke (HEXORR)
Primary Purpose
Stroke, Movement Disorders, Hemiparesis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HEXORR
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring robotic therapy, finger, hand
Eligibility Criteria
Inclusion Criteria:
- a diagnosis of stroke more than 6 months prior to randomization
- presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
- adequate cognitive status, as determined by Mini-Mental Status Examination score >24
Exclusion Criteria:
- were under the influence of oral or injected antispasticity medications during the study
- had MCP and IP passive extension limit > 30 degrees from full extension
- had pain that interfered with daily activities
- had excessive tone in the fingers and thumb as determined by Ashworth scores >=3
- had severe sensory loss or hemispatial neglect as determined by clinical exam.
Sites / Locations
- MedStar National Rehabilitation Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
low-dosage robot therapy
hi-dosage robot therapy
Arm Description
12 sessions of robotic therapy over 4-5 weeks
24 sessions of robotic therapy over 8-10 weeks
Outcomes
Primary Outcome Measures
Change in Fugl-Meyer Test of Motor Function
Measures motor impairment in the upper extremity after stroke
Secondary Outcome Measures
Change in Action Research Arm Test
Measures functional limitations of the upper extremity
Change in finger extension range of motion (degrees)
Motion capture of finger and thumb movement will be used to assess extension ability in units of degrees. The task will be to open the hand as far as possible from a closed fist. Data from all digits will be averaged to provide a single metric for extension ability of the fingers and thumb.
Change in Modified Ashworth Test
Measures hypertonia in the flexors of the fingers, wrist and elbow joints
Change in Motor Activity Log
Measures the amount of use of the upper extremity in ADL
Change in Grip Strength
Jamar Dynamometer
Full Information
NCT ID
NCT04536987
First Posted
July 29, 2020
Last Updated
August 28, 2020
Sponsor
The Catholic University of America
Collaborators
MedStar National Rehabilitation Network
1. Study Identification
Unique Protocol Identification Number
NCT04536987
Brief Title
Robot Therapy for Rehabilitation of Hand Movement After Stroke
Acronym
HEXORR
Official Title
Robot Therapy for Rehabilitation of Hand Movement After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 4, 2012 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
January 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Catholic University of America
Collaborators
MedStar National Rehabilitation Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.
Detailed Description
The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function 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, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Movement Disorders, Hemiparesis
Keywords
robotic therapy, finger, hand
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Random assignment to two study groups
Masking
Outcomes Assessor
Masking Description
Staff performing clinical evaluations was unaware of the study design.
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low-dosage robot therapy
Arm Type
Experimental
Arm Description
12 sessions of robotic therapy over 4-5 weeks
Arm Title
hi-dosage robot therapy
Arm Type
Experimental
Arm Description
24 sessions of robotic therapy over 8-10 weeks
Intervention Type
Device
Intervention Name(s)
HEXORR
Intervention Description
The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Test of Motor Function
Description
Measures motor impairment in the upper extremity after stroke
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Change in Action Research Arm Test
Description
Measures functional limitations of the upper extremity
Time Frame
6 month follow-up
Title
Change in finger extension range of motion (degrees)
Description
Motion capture of finger and thumb movement will be used to assess extension ability in units of degrees. The task will be to open the hand as far as possible from a closed fist. Data from all digits will be averaged to provide a single metric for extension ability of the fingers and thumb.
Time Frame
6 month follow-up
Title
Change in Modified Ashworth Test
Description
Measures hypertonia in the flexors of the fingers, wrist and elbow joints
Time Frame
6 month follow-up
Title
Change in Motor Activity Log
Description
Measures the amount of use of the upper extremity in ADL
Time Frame
6 month follow-up
Title
Change in Grip Strength
Description
Jamar Dynamometer
Time Frame
6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a diagnosis of stroke more than 6 months prior to randomization
presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
adequate cognitive status, as determined by Mini-Mental Status Examination score >24
Exclusion Criteria:
were under the influence of oral or injected antispasticity medications during the study
had MCP and IP passive extension limit > 30 degrees from full extension
had pain that interfered with daily activities
had excessive tone in the fingers and thumb as determined by Ashworth scores >=3
had severe sensory loss or hemispatial neglect as determined by clinical exam.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lum
Organizational Affiliation
The Catholic University of America
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar National Rehabilitation Network
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share data.
Citations:
PubMed Identifier
25667355
Citation
Godfrey SB, Holley RJ, Lum PS. Evaluation of HEXORR Tone Assistance Mode Against Spring Assistance. IEEE Trans Neural Syst Rehabil Eng. 2015 Jul;23(4):610-7. doi: 10.1109/TNSRE.2015.2398933. Epub 2015 Feb 4.
Results Reference
background
PubMed Identifier
23900016
Citation
Godfrey SB, Holley RJ, Lum PS. Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. Am J Phys Med Rehabil. 2013 Nov;92(11):947-58. doi: 10.1097/PHM.0b013e31829e7a07.
Results Reference
background
PubMed Identifier
20667083
Citation
Schabowsky CN, Godfrey SB, Holley RJ, Lum PS. Development and pilot testing of HEXORR: hand EXOskeleton rehabilitation robot. J Neuroeng Rehabil. 2010 Jul 28;7:36. doi: 10.1186/1743-0003-7-36.
Results Reference
background
Learn more about this trial
Robot Therapy for Rehabilitation of Hand Movement After Stroke
We'll reach out to this number within 24 hrs