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OpenTrials
Completed

NCT Number: NCT07557940

Real World Upper Extremity Activity of Stroke Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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. Accelerometry metrics

    Time frame: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)

    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)

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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