StrokeNCT03986216
Development of a FES Device for Hand Use During Arm Activities Following Stroke
A study testing ReIn-Hand device assisted home-based practice in people with Stroke and Hand Function, run by Northwestern University at 1 site in United States.
Trial summary
The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during lifting and reaching. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Hand Function
- What is being tested?
- ReIn-Hand device assisted home-based practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21-80
- Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (Upper Extremity Fugl-Meyer Assessment (UEFMA) in the range of 10-40/66, Chedoke McMaster Stroke Assessment Hand (CMSA_H) stage of the hand section <=4)
- Normal Cognitive ability (MOCA score >=24)
- Capacity to provide informed consent
- Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and then to generate some active elbow extension
- Ability to open hand with a thumb-to-index finger distance ≥4 cm, with the assistance of the ReIn-Hand device with the help of a physical therapist
- Discharged from all forms of physical rehabilitation
- Intact skin on the hemiparetic arm
Who cannot join
- Motor or sensory impairment in the non-affected limb
- Any brainstem and/or cerebellar lesion
- Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
- History of neurologic disorder other than stroke (Parkinson's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy)
- Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
- Using cardiac pacemaker
Show all 13Show fewer
- Seizure
- Severe upper extremity sensory impairment indicated by absent sharp-blunt discrimination on the tactile sensation subscale of the Revised Nottingham Sensory Assessment( the score >=1 on anterior and posterior forearm)
- Chemo denervation: botulinum toxin injection to any portion of the paretic UE within the last 6 months, or phenol/alcohol injections <12 months before participation
- Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods
- Flexion contractures larger than 30 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP)
- Pregnant or planning to become pregnant
- Upper extremity musculoskeletal impairment limiting function prior to stroke.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Dept. of PTHMS
Chicago, Illinois, 60611
About this study
Official title: Development of a Portable Synergy Resistant EMG-driven FES Device for Intuitive Control of Grasp and Release During Functional Arm Activities Following Stroke
The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during lifting and reaching. Furthermore, to enable sufficient practice intensity both in the clinic and at home, the investigators propose to develop the ReIn-Hand device with easy-to-use utilities by developing a user-customized forearm/hand orthosis with embedded EMG recording and stimulation electrode. To test the device feasibility, a small clinical trial will be conducted. Information related to the clinical trial will be provided below.
Read the detailed description
Individuals with moderate to severe stroke will be recruited for both lab-based testing and home-based practice:
- Pre-training clinical evaluation (lab-based). In this session, a research physical therapist will evaluate the participant's arm function and impairment level using standardized clinical assessments to ensure eligibility for participating in this study. Once confirmed, a set of standardized clinical assessments will be conducted by the research physical therapist as the baseline assessments of the participant's hand/arm function. This visit is expected to last approximately 3 hours.
- Pre-training device setup (lab-based). The participant will be randomly assigned to one of the recruited physical therapists (PTs) or senior student physical therapists (SPTs) who has been recruited and consented to participate in this study. The assigned PT will determine 1) the electrode positions for recording the participant's muscle activities during the performance of different arm/hand functions, and 2) the stimulation electrode positions and stimulation intensities for achieving the best hand opening with the forearm at the individual's mid-range of available supination/pronation. Then, the corresponding electrode positions will be marked, and the forearm/hand with these markers will be scanned. This visit is expected to last approximately 3 hours. The scanned results will be used offline to develop a forearm-hand orthosis (FHO) that fits the participant's forearm and hand. During this visit, the investigators will measure the time for the PT/SPT to set up 1) recording electrodes, 2) detecting rules, 3) stimulation electrodes and configuration, and 4) the time for scanning.
- Pre-training device-use learning sessions (2 visits, lab-based). After the FHO is ready, the participant will be called to participate in the 1st and 2nd lab-based training sessions for the use of ReIn-hand device. During these 2 visits, the assigned PT/SPT (1st test) or the research PT (2nd test) will train the participant to use the FHO and the ReIn-Hand software on a mobile device, until the participant demonstrates the ability in using the device independently twice in a row. During these 2 visits, the investigators will measure the time for the participant to 1) learn the use of the ReIn-Hand device (from the start of the session to the time that the participant is able to demonstrate ability to independently use the device twice in a row), 2) attach the FHO, 3) use the software for 1 trial (including connecting all the cables following the instructions, start the software and finish 1 trial), and 4) clean up. At the end of the 1st (for PTs) or the 2nd (for individuals with stroke) learning sessions, a 5min user survey will be conducted to report the level of ease-of-use of the ReIn-Hand device. During the 2nd learning session, the participant will also be re-tested on part of the clinical assessments, however, this time with the assistance of the ReIn-Hand device. Each of these 2 visits is expected to last about 3 hours.
- Pre-training 2nd baseline clinical measures (lab-based). Within one week prior to starting the Home-based practice, a research PT will conduct the 2nd baseline clinical measures, which will repeat the 1st baseline clinical measures with an additional quantitative measure of maximal hand opening area and closing force (QMHOC). For QMHOC, pressure sensors (Pressure Profile Systems, Inc., Los Angeles, CA 90045) in conjunction with portable Moire Phase Tracking cameras (Metria Innovation, Inc., Wauwatosa, WI) will be used. The whole QMHOC will take about 10 minutes, and the whole 2nd baseline clinical measure session will take about 2 hours.
- Pre-training EEG measures (lab-based). Within one week prior to starting the Home-based practice and within one week following completion of the 12-week Home-based practice, the participant will take part in an EEG experiment. During this session, a 9x9 mm marker will be placed on the tip of each finger, with another on the back of the hand as reference, which will allow for the measure of the position and angle of the fingers/hand by 2 portable Moire Phase Tracking cameras (180 Hz; Metria Innovation Inc. Milwaukee, WI). In addition, surface EEG electrodes will be mounted on a stretchable fabric cap based on the 10/20 system. A Polaris Krios handheld scanner and reflective markers (NDI, Ontario, Canada) will be used to record the EEG electrode positions compared to the coordinate system defined by the nasion, inion, and pre-auricular notches. Eye movement detection electrodes will also be placed on the supra- and infra-orbital margins for detection of vertical eye movement. EMG will be recorded from the extensor carpi radialis, flexor carpi radialis, and deltoid of the arm. Once prepared, the participant will be seated in an experimental chair with: 1) adjustable straps across the shoulders and waist to maintain proper posture, 2) paretic forearm attached to an orthosis that is linked to the Arm Coordination Training 3D robot(ACT-3D), a robot that will provide required arm support, 3) hand around a cylinder with a custom pressure sensor mat (Pressure Profile System Inc., CA). The participant will be instructed to perform 1 of 2 movements: 1) hand opening while resting on a haptic table, or 2) hand opening while lifting against 50% of their maximum shoulder abduction force. The investigator will measure scalp recordings and EMG recordings using a 160-channel EEG/EMG system using active electrodes (Biosemi, Inc., Active II, Amsterdam, The Netherlands), hand opening area or finger flexion force.
- Home-based practice. After above 5 lab-based visits, participants will take the ReIn-Hand device, including the FHO, the mobile device with ReIn-Hand software, and the electronic stimulator (EMPI 300PV, Minnesota, USA, a FDA approved clinical device) back home. At home, participants will perform 20 trials of pre-set tasks, like reaching and grasping, per session (1 hour), 1 session per day, 7 days per week for 12 weeks. During these 12 weeks, the participant will visit the lab once per week to make necessary device changes, and perform part of the clinical assessments and QMHOC measure without the ReIn-hand.
- Post-training tests (lab-based). The sessions #4 mentioned above will be repeated at one week and 3-month after the 12-week home-based practice. The session #5 will be repeated at one week after the 12-week home-based practice. All the post-training tests will be preformed without ReIn-hand device.
- Conditions
- Stroke, Hand Function
- Being tested
- ReIn-Hand device assisted home-based practice
- Keywords
- Stroke rehabilitation, Hand opening, Functional electrical stimulation, Home-based intervention, Task-specific practice, Device-assisted practice
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReIn-Hand device assisted home-based practiceDevice
Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
| Study group | Role | What they receive |
|---|---|---|
| Home based group | Experimental | This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed reliable and intuitive control of the paretic hand device (ReIn-Hand device) to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. Receives: Device: ReIn-Hand device assisted home-based practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention
Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimensions by means of a partition. One hundred and fifty small wooden cubes or blocks are placed in one compartments or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one minute trial period. Patients hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time count as a single block. The reported results have decimals since we take the mean of 2 baseline assessments.
Measured: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.
Secondary outcomes (8)
Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score
The Fugl-Meyer Assessment of Motor Recovery after stroke evaluates and measures recovery in post-stroke hemiplegic patients. It is used in both the clinical and research settings, and is one of the most widely used quantitative measures of motor impairment. Areas of assessment include activities of daily living, functional mobility, and pain. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the movement. Scores range from 0-66, with 0 and 66 representing no and normal residual upper extremity motor function, respectively. Higher scores indicate a better outcome.
Measured: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Quantitative Measure of Hand Opening Area and Closing Force
Individual will be instructed to rest paretic hand on a cylinder that is covered with an array of pressure sensors (Pressure Profile Systems, Inc., Los Angeles, California 90045). Furthermore, 5 markers (9x9 mm) with unique optical features will be placed on the tip of the thumb and the 4 fingers. Individual will then be instructed to perform following task in their comfortable pace: 1) resting, 2) maximally open the paretic hand, and 3) maximally close the paretic hand against the cylinder. Position (with an accuracy of 1mm) and angular (with an accuracy at 0.02 degree) information of fingertips will be captured by 2 registered portable Moire Phase Tracking cameras (Metria Innovation, Inc., Wauwatosa, WI); and the flexion force under the 4 fingers and thumb will be measured by the pressure sensors. This will allow for tracking of the hand pentagon area and closing force during intervention.
Measured: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up
Sensory Assessment (Stereognosis)
Stereognosis refers to the ability to identify or perceive the material quality of objects through touch alone, in the absence of visual or auditory stimuli. The individual will be asked to use their paretic hand to identify a number of everyday items through touch alone. Scores range from 0-24, with 24 indicating full stereognosis function and 0 representing complete absence of stereognosis. Decimals are included in the lower and upper limits of the Full Range in the "baseline" row as these resulted from the averaging of two baseline scores.
Measured: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments
The monofilament test is a threshold assay used to determine the minimum force that can be felt by a subject. This test is also known as light touch/protective touch/deep pressure testing in the hands. There are 6 monofilament sizes used to test, with each having a corresponding target force in grams. They are as follows, with the target force in grams in parentheses:
2.83 (0.07) - Normal 3.61 (0.4) - Diminished Light Touch 4.31 (2) - Diminished Protective Sensation 4.56 (4) - Loss of Protective Sensation 5.07 (10) - Loss of Protective Sensation 6.65 (300) - Deep Pressure Sensation only
6 parts of the hand were tested. These 6 values were then averaged. The minimum score for the test is 2.83 and the maximum score is 6.65. For any participant who was unable to sense above 6.65, we applied the score of 6.65 in the analysis. Lower scores indicate a better outcome.
Measured: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.
Stroke Impact Scale (SIS)
The SIS is a 59 item measure of strength, hand function, activities of daily living, mobility, communication, emotion, memory, and participation. Each item is rated in a 5 point scale in terms of difficulty experienced in completing the item, ranging from 1 (could not do it at all) to 5 (not difficult at all).
We reported here the total of strength (minimum possible score 4 and maximum possible score 20) and hand portion (minimum possible score 5 and maximum possible score 25). Subscale scores were summed to compute the total score (minimum possible score 9 and maximum possible score 45). Decimals are included in the lower and upper limits of the Full Range in the "baseline" row as these resulted from the averaging of two baseline scores.
Measured: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Action Research Arm Test (ARAT)
The ARAT test is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). ARAT is a validated quick (within ten to fifteen minutes) assessment of the paretic arm's functional disabilities, which offers uncomplicated and comprehensive feedback on the function of their arm, hand and fingers. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points. Higher scores indicate better performance. Decimals are included in the lower and upper limits of the Full Range in the "baseline" row as these resulted from the averaging of two baseline scores.
Measured: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.
Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale
This test evaluate the stage of motor recovery for the paretic hand. Scores range from 0-7, with 7 representing full function of the hand.
Measured: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Revised Nottingham Sensory Assessment: Kinaesthesia Subscale
The kinaesthesia subscale measures an individuals ability to sense movement, direction of movement, and position sense at a given joint. The assessment involves the tester initiating passive movement in the individuals affected finger, wrist, elbow, and shoulder; while the individual attempts to match those movement with their opposite extremity. Scores for each joint range from 0-3, with higher scores meaning a better outcome.
0 - Absent - no appreciation of movement taking place
- - appreciation of movement taking place
- - direction of movement sense
- - joint position sense The minimum score is 0 and the maximum score is 12. Decimals are included in the lower and upper limits of the Full Range in the "baseline" row as these resulted from the averaging of two baseline scores.
Measured: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start17 May 2019
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a small clinical trial to determine the feasibility of the product for the purpose of home-based arm/hand practice. We will recruit 2-4 stroke participants to participate the small clinical trial (i.e., the home based practice).
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Yao, Northwestern University
- Investigators
- Jun Yao, PhD, Principal investigator, Department of Physical Therapy and Human Movement Sciences, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986216
- Sponsor's protocol ID
- STU00072008
- Status last verified
- Aug 2023
- First submitted
- 1 May 2019
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Carmona C, Sullivan JE, Arceo R, Drogos J, Besser S, Gutierrez S, Jeteric Z, Wyman J, Yao J. Development and Preliminary Validity Study of a Modified Version of the Upper Extremity Fugl-Meyer Assessment for Use in Telerehabilitation. J Neurol Phys Ther. 2023 Oct 1;47(4):208-216. doi: 10.1097/NPT.0000000000000447. Epub 2023 Jun 14.
PubMed 37314323
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Portable Synergy Resistant EMG-driven FES Device for Intuitive Control of Grasp and Release During Functional Arm Activities Following Stroke
- ClinicalTrials.gov ID
- NCT03986216
- Acronym / sponsor ID
- STU00072008
- Conditions
- Stroke, Hand Function
- Keywords
- Stroke rehabilitation, Hand opening, Functional electrical stimulation, Home-based intervention, Task-specific practice, Device-assisted practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Posted 7 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during lifting and reaching. Furthermore, to enable sufficient practice intensity both in the clinic and at home, the investigators propose to develop the ReIn-Hand device with easy-to-use utilities by developing a user-customized forearm/hand orthosis with embedded EMG recording and stimulation electrode. To test the device feasibility, a small clinical trial will be conducted. Information related to the clinical trial will be provided below.
Detailed description
Individuals with moderate to severe stroke will be recruited for both lab-based testing and home-based practice:
- Pre-training clinical evaluation (lab-based). In this session, a research physical therapist will evaluate the participant's arm function and impairment level using standardized clinical assessments to ensure eligibility for participating in this study. Once confirmed, a set of standardized clinical assessments will be conducted by the research physical therapist as the baseline assessments of the participant's hand/arm function. This visit is expected to last approximately 3 hours.
- Pre-training device setup (lab-based). The participant will be randomly assigned to one of the recruited physical therapists (PTs) or senior student physical therapists (SPTs) who has been recruited and consented to participate in this study. The assigned PT will determine 1) the electrode positions for recording the participant's muscle activities during the performance of different arm/hand functions, and 2) the stimulation electrode positions and stimulation intensities for achieving the best hand opening with the forearm at the individual's mid-range of available supination/pronation. Then, the corresponding electrode positions will be marked, and the forearm/hand with these markers will be scanned. This visit is expected to last approximately 3 hours. The scanned results will be used offline to develop a forearm-hand orthosis (FHO) that fits the participant's forearm and hand. During this visit, the investigators will measure the time for the PT/SPT to set up 1) recording electrodes, 2) detecting rules, 3) stimulation electrodes and configuration, and 4) the time for scanning.
- Pre-training device-use learning sessions (2 visits, lab-based). After the FHO is ready, the participant will be called to participate in the 1st and 2nd lab-based training sessions for the use of ReIn-hand device. During these 2 visits, the assigned PT/SPT (1st test) or the research PT (2nd test) will train the participant to use the FHO and the ReIn-Hand software on a mobile device, until the participant demonstrates the ability in using the device independently twice in a row. During these 2 visits, the investigators will measure the time for the participant to 1) learn the use of the ReIn-Hand device (from the start of the session to the time that the participant is able to demonstrate ability to independently use the device twice in a row), 2) attach the FHO, 3) use the software for 1 trial (including connecting all the cables following the instructions, start the software and finish 1 trial), and 4) clean up. At the end of the 1st (for PTs) or the 2nd (for individuals with stroke) learning sessions, a 5min user survey will be conducted to report the level of ease-of-use of the ReIn-Hand device. During the 2nd learning session, the participant will also be re-tested on part of the clinical assessments, however, this time with the assistance of the ReIn-Hand device. Each of these 2 visits is expected to last about 3 hours.
- Pre-training 2nd baseline clinical measures (lab-based). Within one week prior to starting the Home-based practice, a research PT will conduct the 2nd baseline clinical measures, which will repeat the 1st baseline clinical measures with an additional quantitative measure of maximal hand opening area and closing force (QMHOC). For QMHOC, pressure sensors (Pressure Profile Systems, Inc., Los Angeles, CA 90045) in conjunction with portable Moire Phase Tracking cameras (Metria Innovation, Inc., Wauwatosa, WI) will be used. The whole QMHOC will take about 10 minutes, and the whole 2nd baseline clinical measure session will take about 2 hours.
- Pre-training EEG measures (lab-based). Within one week prior to starting the Home-based practice and within one week following completion of the 12-week Home-based practice, the participant will take part in an EEG experiment. During this session, a 9x9 mm marker will be placed on the tip of each finger, with another on the back of the hand as reference, which will allow for the measure of the position and angle of the fingers/hand by 2 portable Moire Phase Tracking cameras (180 Hz; Metria Innovation Inc. Milwaukee, WI). In addition, surface EEG electrodes will be mounted on a stretchable fabric cap based on the 10/20 system. A Polaris Krios handheld scanner and reflective markers (NDI, Ontario, Canada) will be used to record the EEG electrode positions compared to the coordinate system defined by the nasion, inion, and pre-auricular notches. Eye movement detection electrodes will also be placed on the supra- and infra-orbital margins for detection of vertical eye movement. EMG will be recorded from the extensor carpi radialis, flexor carpi radialis, and deltoid of the arm. Once prepared, the participant will be seated in an experimental chair with: 1) adjustable straps across the shoulders and waist to maintain proper posture, 2) paretic forearm attached to an orthosis that is linked to the Arm Coordination Training 3D robot(ACT-3D), a robot that will provide required arm support, 3) hand around a cylinder with a custom pressure sensor mat (Pressure Profile System Inc., CA). The participant will be instructed to perform 1 of 2 movements: 1) hand opening while resting on a haptic table, or 2) hand opening while lifting against 50% of their maximum shoulder abduction force. The investigator will measure scalp recordings and EMG recordings using a 160-channel EEG/EMG system using active electrodes (Biosemi, Inc., Active II, Amsterdam, The Netherlands), hand opening area or finger flexion force.
- Home-based practice. After above 5 lab-based visits, participants will take the ReIn-Hand device, including the FHO, the mobile device with ReIn-Hand software, and the electronic stimulator (EMPI 300PV, Minnesota, USA, a FDA approved clinical device) back home. At home, participants will perform 20 trials of pre-set tasks, like reaching and grasping, per session (1 hour), 1 session per day, 7 days per week for 12 weeks. During these 12 weeks, the participant will visit the lab once per week to make necessary device changes, and perform part of the clinical assessments and QMHOC measure without the ReIn-hand.
- Post-training tests (lab-based). The sessions #4 mentioned above will be repeated at one week and 3-month after the 12-week home-based practice. The session #5 will be repeated at one week after the 12-week home-based practice. All the post-training tests will be preformed without ReIn-hand device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a small clinical trial to determine the feasibility of the product for the purpose of home-based arm/hand practice. We will recruit 2-4 stroke participants to participate the small clinical trial (i.e., the home based practice).
| Arm | Type | Receives |
|---|---|---|
| Home based group | Experimental | Device: ReIn-Hand device assisted home-based practiceThis group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed reliable and intuitive control of the paretic hand device (ReIn-Hand device) to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 21-80
- Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (Upper Extremity Fugl-Meyer Assessment (UEFMA) in the range of 10-40/66, Chedoke McMaster Stroke Assessment Hand (CMSA_H) stage of the hand section <=4)
- Normal Cognitive ability (MOCA score >=24)
- Capacity to provide informed consent
- Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and then to generate some active elbow extension
Key exclusion criteria (13 listed)
- Motor or sensory impairment in the non-affected limb
- Any brainstem and/or cerebellar lesion
- Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
- History of neurologic disorder other than stroke (Parkinson's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy)
- Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
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 |
|---|---|---|
| ReIn-Hand device assisted home-based practicePractice reach-grasp-retrieve-release at home with the aid of ReIn-hand device | Device | Home based group |
Primary outcome
Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention
Time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.
Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimensions by means of a partition. One hundred and fifty small wooden cubes or blocks are placed in one compartments or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one minute trial period. Patients hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time count as a single block. The reported results have decimals since we take the mean of 2 baseline assessments.
8 secondary outcomes
Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score
Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Quantitative Measure of Hand Opening Area and Closing Force
Time frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up
Sensory Assessment (Stereognosis)
Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments
Time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.
Stroke Impact Scale (SIS)
Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Action Research Arm Test (ARAT)
Time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.
Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale
Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Revised Nottingham Sensory Assessment: Kinaesthesia Subscale
Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37314323Carmona C, Sullivan JE, Arceo R, Drogos J, Besser S, Gutierrez S, Jeteric Z, Wyman J, Yao J. Development and Preliminary Validity Study of a Modified Version of the Upper Extremity Fugl-Meyer Assessment for Use in Telerehabilitation. J Neurol Phys Ther. 2023 Oct 1;47(4):208-216. doi: 10.1097/NPT.0000000000000447. Epub 2023 Jun 14.
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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.
Jun Yao, PhD principal investigator
Department of Physical Therapy and Human Movement Sciences, Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReIn-Hand device assisted home-based practice in people with Stroke and Hand Function, run by Northwestern University 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 8 inclusion and 13 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 7 Mar 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention (time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.). 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 NCT03986216, which also lists 1 linked publication.
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 7 Mar 2024.