- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536987
Robot Therapy for Rehabilitation of Hand Movement After Stroke (HEXORR)
August 28, 2020 updated by: The Catholic University of America
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar National Rehabilitation Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: low-dosage robot therapy
12 sessions of robotic therapy over 4-5 weeks
|
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.
|
EXPERIMENTAL: hi-dosage robot therapy
24 sessions of robotic therapy over 8-10 weeks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fugl-Meyer Test of Motor Function
Time Frame: 6 month follow-up
|
Measures motor impairment in the upper extremity after stroke
|
6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Action Research Arm Test
Time Frame: 6 month follow-up
|
Measures functional limitations of the upper extremity
|
6 month follow-up
|
Change in finger extension range of motion (degrees)
Time Frame: 6 month follow-up
|
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.
|
6 month follow-up
|
Change in Modified Ashworth Test
Time Frame: 6 month follow-up
|
Measures hypertonia in the flexors of the fingers, wrist and elbow joints
|
6 month follow-up
|
Change in Motor Activity Log
Time Frame: 6 month follow-up
|
Measures the amount of use of the upper extremity in ADL
|
6 month follow-up
|
Change in Grip Strength
Time Frame: 6 month follow-up
|
Jamar Dynamometer
|
6 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter Lum, The Catholic University of America
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 4, 2012
Primary Completion (ACTUAL)
January 15, 2017
Study Completion (ACTUAL)
January 15, 2017
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (ACTUAL)
September 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 3, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share data.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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