NCT01391949

Brief Summary

This purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2 stroke

Timeline
Completed

Started Jul 2011

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

3.9 years

First QC Date

July 11, 2011

Last Update Submit

May 17, 2022

Conditions

Keywords

disabilitywalkingfeedbackexercise

Outcome Measures

Primary Outcomes (1)

  • Walking speed

    Fastest safe walking speed over 10 meters

    three months

Secondary Outcomes (1)

  • Distance walked in 3 minutes

    three months

Study Arms (2)

Detailed feedback

EXPERIMENTAL

Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.

Behavioral: Detailed feedback

Basic feedback

ACTIVE COMPARATOR

Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.

Behavioral: Basic feedback

Interventions

Once a week subjects will receive feedback about the total time spent cycling and walking in the previous week. Subjects in this intervention group will also receive feedback about average cycling speed, distance pedaled, average walking speed, and distance walked in the previous week.

Detailed feedback
Basic feedbackBEHAVIORAL

Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.

Basic feedback

Eligibility Criteria

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

You may qualify if:

  • diagnosis of stroke
  • no major contraindications to participating in light-to-moderate exertion
  • able to follow and retain verbal directions to carry out simple lower extremity repetitive exercises
  • planned discharge to home with family available to assist

You may not qualify if:

  • pre-morbid limitations in walking related to another medical disease
  • body mass index \>30
  • fractures or contractures that prevent use of an extremity for pedaling
  • impairment in cognition that precludes a full understanding of the risks and benefits of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Andrew Dorsch, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Bruce Dobkin, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations