StrokeNCT07557940
Real World Upper Extremity Activity of Stroke Survivors
An observational study of Stroke, run by Shirley Ryan AbilityLab.
Trial summary
The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of Upper Extremity (UE) activity and see if these improve over the course of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jan 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Diagnosis of unilateral stroke, according to ICD-9 criteria, resulting in residual upper extremity hemiparesis * At least 18 years of age * Receiving occupational therapy in outpatient or day rehabilitation setting * Motricity Index Score between 29-91 points * Ability to follow a 1 step command as indicated by a score of 0 to 1 on the command items of the National Institute of Health Stroke Scale (NIHSS) * All subject must have the ability to provide signed, informed consent
Who may be able to join
- Diagnosis of unilateral stroke, according to ICD-9 criteria, resulting in residual upper extremity hemiparesis
- At least 18 years of age
- Receiving occupational therapy in outpatient or day rehabilitation setting
- Motricity Index Score between 29-91 points
- Ability to follow a 1 step command as indicated by a score of 0 to 1 on the command items of the National Institute of Health Stroke Scale (NIHSS)
- All subject must have the ability to provide signed, informed consent
Who cannot join
- • A history of other diagnosed neurological condition
- A history of other diagnosed psychiatric condition
- Inability to follow 1 step command
- Currently pregnant or seeking pregnancy
About this study
The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of Upper Extremity (UE) activity and see if these improve over the course of therapy.
Read the detailed description
Occupational therapists utilize a battery of standardized assessments at evaluation and throughout the duration of services. These performance-based assessments measure abilities at impairment and activity levels (e.g. grip strength and the Action Research Arm Test). The assumption is made that improved performance on these in-clinic assessments correlates to increased UE activity outside the clinic in daily life. This assumption however, is unsupported by current evidence. Currently, self report measures (e.g. Stroke Impact Scale, Motor Activity Log) are used in both clinical and research settings to gather data on activity outside of therapy time. These measures however, are subject to bias, particularly for physical activity. Social desirability, or the tendency of individuals to portray themselves in keeping up with norms, has been linked specifically to the bias of self report measures. It was found that durations of light and moderate activity were over reported by as much as 79 min/day. These numbers indicate that participants tend to overestimate the amount of activity throughout their day in order to please their provider according to their perceived acceptable norms.
In recent years, accelerometry has been established as an objective, unbiased tool for measuring real world UE activity. Accelerometers have been used to track UE activity in the inpatient rehabilitation setting and then compared to healthy controls. This comparison indicated that healthy individuals use their dominant and non-dominant arms 8-9 hours per day. Individuals with stroke demonstrate significantly less UE use; using their affected arm approximately 3.3 hours and their unaffected arm 6.0 hours per day. A recent study with community dwelling healthy individuals confirmed that healthy individuals use their dominant hand 9 hours and their non-dominant hand 8.6 hours per day. These newer data indicate that regardless of dominance, patients post stroke use their affected limb significantly less than healthy individuals in the community.
Using the framework from previous accelerometry studies, the proposed research study will address the critical need to understand real world UE activity in stroke survivors undergoing standard outpatient occupational therapy. The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of UE activity and see if these improve over the course of therapy. These data will help clinicians understand actual UE usage during everyday activities outside of prescribed therapy time. Clinicians will be able to tell if the interventions they are providing are increasing activity in the real world, and not just increasing patient performance in the clinic.
- Conditions
- Stroke
- Keywords
- upper extremity, accelerometry
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Action research arm test
the ARAT, two sections of the Stroke Impact Scale will be administered via interview format. The two sections (hand and participation in activities at home) will capture each subject's perceived participation related to UE activity.
Measured: change from baseline to post 30 days, and discharge from inpatient hospitalization up to 12 weeks)
Secondary outcomes (2)
Stroke Impact Scale (SIS)
Two sections of the Stroke Impact Scale will be administered via interview format. The two sections (hand and participation in activities at home) will capture each subject's perceived participation related to UE activity.
Measured: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)
Accelerometry metrics
The accelerometers track UE movement along three axes. Data are recorded as a time-series of numbers (in activity counts, where 1 count = 0.016318 g), collected every second over the 24-48 hour wearing period. The second outcome is counts (number of repetitions)
Measured: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
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.
- More trials run by Shirley Ryan AbilityLabThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas G Hornby, Shirley Ryan AbilityLab
- Investigators
- Thomas Hornby, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557940
- Sponsor's protocol ID
- STU00103287
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2015
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Upper Extremity Activity of Stroke Survivors
- ClinicalTrials.gov ID
- NCT07557940
- Acronym / sponsor ID
- STU00103287
- Conditions
- Stroke
- Keywords
- upper extremity, accelerometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Apr 2026 (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.
The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of Upper Extremity (UE) activity and see if these improve over the course of therapy.
Detailed description
Occupational therapists utilize a battery of standardized assessments at evaluation and throughout the duration of services. These performance-based assessments measure abilities at impairment and activity levels (e.g. grip strength and the Action Research Arm Test). The assumption is made that improved performance on these in-clinic assessments correlates to increased UE activity outside the clinic in daily life. This assumption however, is unsupported by current evidence. Currently, self report measures (e.g. Stroke Impact Scale, Motor Activity Log) are used in both clinical and research settings to gather data on activity outside of therapy time. These measures however, are subject to bias, particularly for physical activity. Social desirability, or the tendency of individuals to portray themselves in keeping up with norms, has been linked specifically to the bias of self report measures. It was found that durations of light and moderate activity were over reported by as much as 79 min/day. These numbers indicate that participants tend to overestimate the amount of activity throughout their day in order to please their provider according to their perceived acceptable norms.
In recent years, accelerometry has been established as an objective, unbiased tool for measuring real world UE activity. Accelerometers have been used to track UE activity in the inpatient rehabilitation setting and then compared to healthy controls. This comparison indicated that healthy individuals use their dominant and non-dominant arms 8-9 hours per day. Individuals with stroke demonstrate significantly less UE use; using their affected arm approximately 3.3 hours and their unaffected arm 6.0 hours per day. A recent study with community dwelling healthy individuals confirmed that healthy individuals use their dominant hand 9 hours and their non-dominant hand 8.6 hours per day. These newer data indicate that regardless of dominance, patients post stroke use their affected limb significantly less than healthy individuals in the community.
Using the framework from previous accelerometry studies, the proposed research study will address the critical need to understand real world UE activity in stroke survivors undergoing standard outpatient occupational therapy. The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of UE activity and see if these improve over the course of therapy. These data will help clinicians understand actual UE usage during everyday activities outside of prescribed therapy time. Clinicians will be able to tell if the interventions they are providing are increasing activity in the real world, and not just increasing patient performance in the clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Diagnosis of unilateral stroke, according to ICD-9 criteria, resulting in residual upper extremity hemiparesis * At least 18 years of age * Receiving occupational therapy in outpatient or day rehabilitation setting * Motricity Index Score between 29-91 points * Ability to follow a 1 step command as indicated by a score of 0 to 1 on the command items of the National Institute of Health Stroke Scale (NIHSS) * All subject must have the ability to provide signed, informed consent
Key inclusion criteria (6 listed)
- Diagnosis of unilateral stroke, according to ICD-9 criteria, resulting in residual upper extremity hemiparesis
Key exclusion criteria (4 listed)
- • A history of other diagnosed neurological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Action research arm test
Time frame: change from baseline to post 30 days, and discharge from inpatient hospitalization up to 12 weeks)
the ARAT, two sections of the Stroke Impact Scale will be administered via interview format. The two sections (hand and participation in activities at home) will capture each subject's perceived participation related to UE activity.
2 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)
Accelerometry metrics
Time frame: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)
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 30 Apr 2026.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
Thomas Hornby principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Shirley Ryan AbilityLab.
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 6 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Action research arm test (time frame: change from baseline to post 30 days, and discharge from inpatient hospitalization up to 12 weeks)). 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 30 Apr 2026.