NCT02995213

Brief Summary

The investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to: i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in individuals chronic post-stroke, ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs, and iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use. iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

December 14, 2016

Last Update Submit

September 25, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Accelerometer based paretic arm amount of use

    3 week period

Study Arms (1)

Feedback Intervention

EXPERIMENTAL
Behavioral: Accelerometer based feedback about paretic arm use

Interventions

Accelerometer based feedback about paretic arm useBEHAVIORAL
Feedback Intervention

Eligibility Criteria

Age25 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects post-stroke
  • chronic post ischemic or hemorrhagic cortical or subcortical stroke
  • years old
  • upper extremity impairment
  • Subjects will need to be able to flex their paretic shoulder and their elbow \> 40° without assist
  • able to follow 2-step commands
  • community dwelling with or without assistance
  • intact superficial light touch sensation in both upper extremities
  • must also have some movement in both arms

You may not qualify if:

  • can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, Parkinson disease or multiple sclerosis
  • no upper extremity injury within the last 3 months

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 16, 2016

Study Start

November 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share