Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity

February 26, 2021 updated by: BioSensics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Recruiting
        • Spaulding Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
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.
Experimental: Intervention
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.
Device: Wearable sensors and biofeedback
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
12 weeks
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)
12 weeks
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)
12 weeks
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).
12 weeks (end of intervention), 20 weeks (follow-up)
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)
12 weeks (end of intervention), 20 weeks (follow-up)
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)
12 weeks (end of intervention), 20 weeks (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Wolf Motor Function Test time-subscale during intervention
Time Frame: 12 weeks
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)
12 weeks
Change in Wolf Motor Function Test quality-subscale during intervention
Time Frame: 12 weeks
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)
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 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)
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)
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)
12 weeks (end of intervention), 20 weeks (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioSensics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spaulding Rehabilitation Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph T Gwin, PhD, BioSensics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P001688/SRH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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