StrokeNCT03431025
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity
A study testing Wearable sensors and biofeedback in people with Stroke and Hemiparesis, run by BioSensics at 1 site in United States.
Trial summary
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Wearable sensors and biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 31 Aug 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
- Mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the Fugl-Meyer scale).
Who cannot join
- Cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the Mini Mental State Examination scale)
- Severe attention deficits or hemispatial neglect (as measured by the Mesulam Cancellation test and the Line Bisection test);
- Severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the Modified Ashworth scale) that would prevent safe performance of home-based exercises;
- Proprioceptive deficits that impair their ability to process feedback (as measured using the Fugl-Meyer Assessment-upper extremity; sensory section).
- Implantable medical devices that are not compliant with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for Bluetooth compatibility. We will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. If not, they will be excluded from the study.
- Participation in upper-extremity rehabilitation program (i.e. outpatient occupational therapy, research study, ...).
- Recent (< 3 months) Botox injection in the upper-extremity or plan to undergo injections during the study timeline.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
Catherine Adans-Dester, PT, 617-952-6321, cadans-dester@partners.org
About this study
Official title: Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Wearable sensors and biofeedback
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable sensors and biofeedbackDevice
Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the Control Arm will wear sensors to monitor their upper limb movement but will not receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living. |
| Intervention | Experimental | Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living. Receives: Device: Wearable sensors and biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer during intervention
Change in Fugl-Meyer Upper Extremity Assessment Scale score from baseline (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Measured: 12 weeks
Change in Motor Activity Log Quality Score during intervention
Change in Motor Activity Log Quality Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Measured: 12 weeks
Change in Motor Activity Log Quantity Score during intervention
Change in Motor Activity Log Quantity Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Measured: 12 weeks
Change in Fugl-Meyer during washout
Change in Fugl-Meyer Upper Extremity Assessment Scale score from end of intervention to follow-up (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Measured: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quality Score during washout
Change in Motor Activity Log Quality Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Measured: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quantity Score during washout
Change in Motor Activity Log Quantity Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Measured: 12 weeks (end of intervention), 20 weeks (follow-up)
Secondary outcomes (4)
Change in Wolf Motor Function Test time-subscale during intervention
Change in Wolf Motor Function Test time-subscale score from baseline (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)
Measured: 12 weeks
Change in Wolf Motor Function Test quality-subscale during intervention
Change in Wolf Motor Function Test quality-subscale score from baseline (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)
Measured: 12 weeks
Change in Wolf Motor Function Test time-subscale during washout
Change in Wolf Motor Function Test time-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)
Measured: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Wolf Motor Function Test quality-subscale during washout
Change in Wolf Motor Function Test quality-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)
Measured: 12 weeks (end of intervention), 20 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start28 Mar 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Rehabilitation Hospital
- Responsible party
- Sponsor
- Investigators
- Joseph T Gwin, PhD, Principal investigator, BioSensicsPaolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431025
- Sponsor's protocol ID
- 2016P001688/SRH
- Status last verified
- Feb 2021
- First submitted
- 23 Jan 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study
- ClinicalTrials.gov ID
- NCT03431025
- Acronym / sponsor ID
- 2016P001688/SRH
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- Spaulding Rehabilitation Hospital
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 13 Feb 2018 (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.
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the Control Arm will wear sensors to monitor their upper limb movement but will not receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living. |
| Intervention | Experimental | Device: Wearable sensors and biofeedbackParticipants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
- Mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the Fugl-Meyer scale).
Key exclusion criteria (7 listed)
- Cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the Mini Mental State Examination scale)
- Severe attention deficits or hemispatial neglect (as measured by the Mesulam Cancellation test and the Line Bisection test);
- Severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the Modified Ashworth scale) that would prevent safe performance of home-based exercises;
- Proprioceptive deficits that impair their ability to process feedback (as measured using the Fugl-Meyer Assessment-upper extremity; sensory section).
- Implantable medical devices that are not compliant with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for Bluetooth compatibility. We will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. If not, they will be excluded from the study.
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 |
|---|---|---|
| Wearable sensors and biofeedbackParticipants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living. | Device | Intervention |
Primary outcome
Change in Fugl-Meyer during intervention
Time frame: 12 weeks
Change in Fugl-Meyer Upper Extremity Assessment Scale score from baseline (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Change in Motor Activity Log Quality Score during intervention
Time frame: 12 weeks
Change in Motor Activity Log Quality Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Change in Motor Activity Log Quantity Score during intervention
Time frame: 12 weeks
Change in Motor Activity Log Quantity Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Change in Fugl-Meyer during washout
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Fugl-Meyer Upper Extremity Assessment Scale score from end of intervention to follow-up (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Change in Motor Activity Log Quality Score during washout
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quality Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Change in Motor Activity Log Quantity Score during washout
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quantity Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
4 secondary outcomes
Change in Wolf Motor Function Test time-subscale during intervention
Time frame: 12 weeks
Change in Wolf Motor Function Test quality-subscale during intervention
Time frame: 12 weeks
Change in Wolf Motor Function Test time-subscale during washout
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Wolf Motor Function Test quality-subscale during washout
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- 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.
Joseph T Gwin, PhD principal investigator
BioSensics
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable sensors and biofeedback in people with Stroke and Hemiparesis, run by BioSensics 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 7 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Adans-Dester, PT (617-952-6321, cadans-dester@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer during intervention (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.