NCT07557940

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10.3 years until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

September 25, 2015

Last Update Submit

April 22, 2026

Conditions

Keywords

upper extremityaccelerometry

Outcome Measures

Primary Outcomes (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.

    change from baseline to post 30 days, and discharge from inpatient hospitalization up to 12 weeks)

Secondary Outcomes (2)

  • Stroke Impact Scale (SIS)

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

  • Accelerometry metrics

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas Hornby

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

September 25, 2015

First Posted

April 30, 2026

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 30, 2026

Record last verified: 2026-04