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StrokeNCT07557940

Real World Upper Extremity Activity of Stroke Survivors

An observational study of Stroke, run by Shirley Ryan AbilityLab.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

  1. 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)
  1. 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)

  2. 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.

  1. First posted30 Apr 2026
  2. Study startNov 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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)
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

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.

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