StrokeNCT02072369
Simulated Home Therapy Program for the Hand After Stroke
A study testing VAEDA Glove and Occupational Therapy in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- VAEDA Glove and Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- Phase
- Interventional
- 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
- chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke)
- moderate hand impairment classified as Stage 4 on the Chedoke McMaster Stroke Assessment
Who cannot join
- anti-spasticity medications/injections taken less than 6 month prior to enrollment
- contractures greater than 20 degrees
- inability to follow single-step commands
- significant upper extremity pain (self-reported pain of greater than 6 on a 10-point scale)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand.
Read the detailed description
Stroke survivors with chronic hemiparesis of the upper extremity undertook 18 one-hour training sessions over a 6-week period. Participants received occupational therapy focusing on grasp-and-release using a task-oriented protocol developed at the Rehabilitation Institute of Chicago by Dr. Mary Ellen Stoykov. Over 90% of all repetitions performed during each session were focused on functional activities, as opposed to active exercise. The skills and strategies developed in therapy were then implemented into activities identified as goals by the participant, such as donning socks. Difficulty of the task, activity, or exercise was progressed for each participant to provide optimal challenge to enhance skill.
Subjects were assigned to one of two groups by casting lots. One group (VAEDA Glove) performed all tasks while wearing a custom Voice And EMG-Driven Actuated glove, the VAEDA Glove. The other group (No-Glove) performed the same types of tasks without use of the VAEDA Glove. The VAEDA Glove is a portable active-assistance glove, designed to assist digit extension in order to allow repeated practice of specified tasks. The glove contains cables traversing the dorsal side of the digits in order to provide extension and resist flexion. Forces are transmitted through the cables from a servomotor located remotely to the digits. The servomotor controls torque or displacement in the cable. Along the digits, the cables traverse through custom plastic blocks, which serve both to guide the cable and to prevent joint hyperextension.
The VAEDA Glove can be controlled with up to 3 channels of electromyography (EMG). For this study, electrodes were placed above flexor digitorum superficialis (FDS) and extensor digitorum communis (EDC). The group using the J-Glove could receive assistance during hand opening, but only if appropriate EMG activity was detected. The EDC EMG activity had to reach a prescribed threshold before extension assistance would be provided. Similarly, FDS EMG activity had to surpass a threshold level during hand closing before the user was allowed to flex the digits. Feedback of muscle activity was available to the user through a custom graphical user interface.
- Conditions
- Stroke
- Being tested
- VAEDA Glove, Occupational Therapy
- Keywords
- stroke, hand, fingers, rehabilitation, training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAEDA GloveOther
Voice And EMG-Driven Actuated glove used during training
Occupational TherapyOther
novel upper extremity occupational therapy focused on the hand
| Study group | Role | What they receive |
|---|---|---|
| VAEDA Glove | Experimental | Voice And EMG-Driven Actuated glove used during hand occupational therapy training Receives: Other: VAEDA Glove; Other: Occupational Therapy |
| No-glove | Active comparator | hand occupational therapy sessions without assistive device Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Action Research Arm Test (ARAT)
Measured: Change from Baseline after 6 weeks of training
Wolf Motor Function Test (WMFT)
Measured: Change from Baseline after 6 weeks of training
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Measured: Change from Baseline after 6 weeks of training
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Measured: Change from Baseline after 6 weeks of training
Action Research Arm Test (ARAT)
Measured: Change from Baseline to 1 month following training completion
Wolf Motor Function Test (WMFT)
Measured: Change from Baseline to 1 month following training completion
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Measured: Change from Baseline to 1 month following training completion
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Measured: Change from Baseline to 1 month following training completion
Secondary outcomes (4)
Hand Kinematics
hand kinematics were measured explicitly with a CyberGlove (CyberGlove Systems LLC, San Jose, CA). From an initially relaxed, resting posture, participants were asked to extend the digits fully ("open") and then flex fully ("close") their affected hand into a fist. The CyberGlove measured joint displacement for each digit during task performance.
Measured: Change from Baseline after 6 weeks of training and 1 month follow up
3-point (palmar) Pinch Strength (PPS)
using a pinch gauge (PG-60, B\&L Engineering)
Measured: Change from Baseline after 6 weeks of training and 1 month follow up
Lateral Pinch Strength (LPS)
using a pinch gauge (PG-60, B\&L Engineering)
Measured: Change from Baseline after 6 weeks of training and 1 month follow up
Grip Strength (GS)
JAMAR 5030J1 Hand Dynamometer
Measured: Change from Baseline after 6 weeks of training and 1 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 posted26 Feb 2014 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Illinois Institute of Technology
- Responsible party
- Principal investigator, Derek Kamper, Shirley Ryan AbilityLab
- Investigators
- Derek G Kamper, PhD, Principal investigator, Illinois Institute of Technology / Rehabilitation Institute of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072369
- Sponsor's protocol ID
- STU00032058
- Other IDs
- H133E070013, MARS
- Status last verified
- Jun 2017
- First submitted
- 20 Feb 2014
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382.
PubMed 22275586Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.
PubMed 19964456
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Home Therapy Program for the Hand After Stroke
- ClinicalTrials.gov ID
- NCT02072369
- Acronym / sponsor ID
- STU00032058
- Conditions
- Stroke
- Keywords
- stroke, hand, fingers, rehabilitation, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Illinois Institute of Technology
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- 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.
The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand.
Detailed description
Stroke survivors with chronic hemiparesis of the upper extremity undertook 18 one-hour training sessions over a 6-week period. Participants received occupational therapy focusing on grasp-and-release using a task-oriented protocol developed at the Rehabilitation Institute of Chicago by Dr. Mary Ellen Stoykov. Over 90% of all repetitions performed during each session were focused on functional activities, as opposed to active exercise. The skills and strategies developed in therapy were then implemented into activities identified as goals by the participant, such as donning socks. Difficulty of the task, activity, or exercise was progressed for each participant to provide optimal challenge to enhance skill.
Subjects were assigned to one of two groups by casting lots. One group (VAEDA Glove) performed all tasks while wearing a custom Voice And EMG-Driven Actuated glove, the VAEDA Glove. The other group (No-Glove) performed the same types of tasks without use of the VAEDA Glove. The VAEDA Glove is a portable active-assistance glove, designed to assist digit extension in order to allow repeated practice of specified tasks. The glove contains cables traversing the dorsal side of the digits in order to provide extension and resist flexion. Forces are transmitted through the cables from a servomotor located remotely to the digits. The servomotor controls torque or displacement in the cable. Along the digits, the cables traverse through custom plastic blocks, which serve both to guide the cable and to prevent joint hyperextension.
The VAEDA Glove can be controlled with up to 3 channels of electromyography (EMG). For this study, electrodes were placed above flexor digitorum superficialis (FDS) and extensor digitorum communis (EDC). The group using the J-Glove could receive assistance during hand opening, but only if appropriate EMG activity was detected. The EDC EMG activity had to reach a prescribed threshold before extension assistance would be provided. Similarly, FDS EMG activity had to surpass a threshold level during hand closing before the user was allowed to flex the digits. Feedback of muscle activity was available to the user through a custom graphical user interface.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAEDA Glove | Experimental | Other: VAEDA Glove, Other: Occupational TherapyVoice And EMG-Driven Actuated glove used during hand occupational therapy training |
| No-glove | Active comparator | Other: Occupational Therapyhand occupational therapy sessions without assistive device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke)
- moderate hand impairment classified as Stage 4 on the Chedoke McMaster Stroke Assessment
Key exclusion criteria (4 listed)
- anti-spasticity medications/injections taken less than 6 month prior to enrollment
- contractures greater than 20 degrees
- inability to follow single-step commands
- significant upper extremity pain (self-reported pain of greater than 6 on a 10-point 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 |
|---|---|---|
| VAEDA GloveVoice And EMG-Driven Actuated glove used during training | Other | VAEDA Glove |
| Occupational Therapynovel upper extremity occupational therapy focused on the hand | Other | No-glove, VAEDA Glove |
Primary outcome
The Action Research Arm Test (ARAT)
Time frame: Change from Baseline after 6 weeks of training
Wolf Motor Function Test (WMFT)
Time frame: Change from Baseline after 6 weeks of training
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Time frame: Change from Baseline after 6 weeks of training
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Time frame: Change from Baseline after 6 weeks of training
Action Research Arm Test (ARAT)
Time frame: Change from Baseline to 1 month following training completion
Wolf Motor Function Test (WMFT)
Time frame: Change from Baseline to 1 month following training completion
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Time frame: Change from Baseline to 1 month following training completion
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Time frame: Change from Baseline to 1 month following training completion
4 secondary outcomes
Hand Kinematics
Time frame: Change from Baseline after 6 weeks of training and 1 month follow up
3-point (palmar) Pinch Strength (PPS)
Time frame: Change from Baseline after 6 weeks of training and 1 month follow up
Lateral Pinch Strength (LPS)
Time frame: Change from Baseline after 6 weeks of training and 1 month follow up
Grip Strength (GS)
Time frame: Change from Baseline after 6 weeks of training and 1 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 27 Jun 2017.
- Background: PubMed 22275586Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382.
- Background: PubMed 19964456Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.
- Individual participant dataSharing planned: No
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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.
Derek G Kamper, PhD principal investigator
Illinois Institute of Technology / Rehabilitation Institute of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAEDA Glove and Occupational Therapy in people with Stroke, run by Shirley Ryan AbilityLab 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 2 inclusion and 4 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 27 Jun 2017. 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?
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?
The Action Research Arm Test (ARAT) (time frame: Change from Baseline after 6 weeks of training). The study lists 8 primary outcomes in all. 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 NCT02072369, which also lists 2 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 27 Jun 2017.