StrokePhase 2HEXORRNCT04536987
Robot Therapy for Rehabilitation of Hand Movement After Stroke
A Phase 2 study testing HEXORR in people with Stroke and Movement Disorders, run by The Catholic University of America at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Movement Disorders, Hemiparesis
- What is being tested?
- HEXORR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2012to 15 Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar National Rehabilitation Network
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Stroke, Movement Disorders, Hemiparesis
- Being tested
- HEXORR
- Keywords
- robotic therapy, finger, hand
- Medical subject headings
- Stroke, Movement Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEXORRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| low-dosage robot therapy | Experimental | 12 sessions of robotic therapy over 4-5 weeks Receives: Device: HEXORR |
| hi-dosage robot therapy | Experimental | 24 sessions of robotic therapy over 8-10 weeks Receives: Device: HEXORR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Test of Motor Function
Measures motor impairment in the upper extremity after stroke
Measured: 6 month follow-up
Secondary outcomes (5)
Change in Action Research Arm Test
Measures functional limitations of the upper extremity
Measured: 6 month follow-up
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.
Measured: 6 month follow-up
Change in Modified Ashworth Test
Measures hypertonia in the flexors of the fingers, wrist and elbow joints
Measured: 6 month follow-up
Change in Motor Activity Log
Measures the amount of use of the upper extremity in ADL
Measured: 6 month follow-up
Change in Grip Strength
Jamar Dynamometer
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start4 Oct 2012
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to two study groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of America
- Sponsor type
- University, hospital or other
- Collaborators
- MedStar National Rehabilitation Network
- Responsible party
- Sponsor
- Investigators
- Peter Lum, Principal investigator, The Catholic University of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536987
- Sponsor's protocol ID
- 2012-315
- Acronym
- HEXORR
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share data.
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.
PubMed 25667355Godfrey 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.
PubMed 23900016Schabowsky 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.
PubMed 20667083
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Therapy for Rehabilitation of Hand Movement After Stroke
- ClinicalTrials.gov ID
- NCT04536987
- Acronym / sponsor ID
- HEXORR / 2012-315
- Conditions
- Stroke, Movement Disorders, Hemiparesis
- Keywords
- robotic therapy, finger, hand
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Catholic University of AmericaUniversity, hospital or other
- Collaborators
- MedStar National Rehabilitation Network
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Random assignment to two study groups
| Arm | Type | Receives |
|---|---|---|
| low-dosage robot therapy | Experimental | Device: HEXORR12 sessions of robotic therapy over 4-5 weeks |
| hi-dosage robot therapy | Experimental | Device: HEXORR24 sessions of robotic therapy over 8-10 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEXORRThe 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. | Device | hi-dosage robot therapy, low-dosage robot therapy |
Primary outcome
Change in Fugl-Meyer Test of Motor Function
Time frame: 6 month follow-up
Measures motor impairment in the upper extremity after stroke
5 secondary outcomes
Change in Action Research Arm Test
Time frame: 6 month follow-up
Change in finger extension range of motion (degrees)
Time frame: 6 month follow-up
Change in Modified Ashworth Test
Time frame: 6 month follow-up
Change in Motor Activity Log
Time frame: 6 month follow-up
Change in Grip Strength
Time frame: 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 25667355Godfrey 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.
- Background: PubMed 23900016Godfrey 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.
- Background: PubMed 20667083Schabowsky 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.
- Individual participant dataSharing planned: No. There is no plan to share data.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lum principal investigator
The Catholic University of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEXORR in people with Stroke and Movement Disorders, run by The Catholic University of America at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Test of Motor Function (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536987, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.