NCT02906956

Brief Summary

The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for early_phase_1 stroke

Timeline
Completed

Started Sep 2016

Shorter than P25 for early_phase_1 stroke

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

September 13, 2016

Last Update Submit

July 12, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of sessions of practice

    4 weeks

  • Duration of sessions of practice

    4 weeks

  • Number of minutes of practice

    4 weeks

Secondary Outcomes (4)

  • Canadian Occupational Performance Measure

    Baseline and no more than one week post intervention period

  • Motor Activity Log

    Baseline and no more than one week post intervention period

  • Western Aphasia Battery - Revised

    Baseline

  • Cognitive Linguistic Quick Test

    Baseline

Other Outcomes (2)

  • Qualitative Feedback Interview

    No more than 3 weeks post intervention period

  • Intensity of Practice

    4 weeks

Study Arms (1)

Preferred Music Playlist

EXPERIMENTAL

All participants will have this phase twice in the protocol. See description in intervention section.

Behavioral: Preferred music playlist

Interventions

Client will be instructed in a home program based on repetitive task practice principles and will complete this program with and without the use of a preferred music playlist during practice.

Preferred Music Playlist

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 40-85
  • Mild to Moderate hemiparesis as determined by a score of 21 to 50 on the FM- UE
  • At least 6 months post stroke
  • American English as primary language

You may not qualify if:

  • Significant visual impairment as determined by "aphasia-friendly" and age appropriate screening
  • Significant hearing impairment as determined by self-report
  • Actively receiving occupational or physical therapy services for upper extremity motor recovery
  • Severe auditory comprehension impairment such that they cannot understand one-step directions as indicated by a WAB-R score below 8/10 on Sequential Commands Subtest
  • Sitting or standing blood pressure of 180/110 or HE \> 100 bpm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University Speech, Hearing, Language Clinic

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Elena V Donoso Brown, PhD

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations