NCT00428480

Brief Summary

The primary purpose of this study is to determine the effects of reinforcement of walking speed on recovery of walking speed over the course of inpatient rehabilitation for people after stroke. The study will also examine the relationship between short distance walking speed and walking distance over a fixed time.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started May 2007

Geographic Reach
10 countries

24 active sites

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

First Submitted

Initial submission to the registry

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 11, 2011

Status Verified

July 1, 2009

Enrollment Period

1.8 years

First QC Date

January 29, 2007

Last Update Submit

November 10, 2011

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Gait speed

    Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months

Secondary Outcomes (3)

  • Distance walked in 3 minutes

    4 weeks, discharge, 3 months, 6 months

  • Functional Ambulation Classification (FAC)

    Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months

  • Number of falls post inpatient rehabilitation

    3 months, 6 months

Study Arms (2)

1

EXPERIMENTAL

Daily reinforcement of walking speed

Behavioral: Daily reinforcement of walking speed (DRS)

2

ACTIVE COMPARATOR

No reinforcement of walking speed

Behavioral: No reinforcement of walking speed (NRS)

Interventions

Daily reinforcement of walking speed (DRS)BEHAVIORAL

Inpatients are encouraged to walk faster and given feedback on their walking speed during a daily 10-meter walk as part of their usual physical therapy.

Also known as: DRS
1
No reinforcement of walking speed (NRS)BEHAVIORAL

Inpatients complete a 10-meter walk as part of their daily physical therapy but are not given any encouragement to walk faster or feedback on their walking speed.

Also known as: NRS
2

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • suffered a stroke from any cause that is unlikely to progress or recur within 2 years of onset (thrombotic infarct, cardioembolus, intracerebral hemorrhage)
  • unilateral hemiparesis with strength of the proximal leg muscles ≤4/5
  • able to follow simple instructions and understand verbal reinforcement about walking speed
  • able to take 5 steps with not more than the assistance of one person

You may not qualify if:

  • premorbid walking difficulty in the community, such as a prior stroke with residual impairment, arthritis with pain on stepping, dyspnea or angina on modest exertion, limited walking endurance due to cardiopulmonary or other disease
  • history of dementia
  • current medical disease that will limit physical therapy at the time of randomization, such as critical illness myopathy/neuropathy, serious infection, thrombophlebitis, orthostatic hypertension, decubitus ulcer, congestive heart failure, chronic obstructive lung disease, organ transplantation, recent surgery (including coronary bypass), or pain with weigh bearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

The Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Kernan Hospital

Baltimore, Maryland, United States

Location

St. Luke's and Whiteside Institute for Clinical Research

Duluth, Minnesota, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

Kessler Medical Rehabilitation Research and Education Corporation

West Orange, New Jersey, United States

Location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Location

Rehabilitation Hospital of Rhode Island

North Smithfield, Rhode Island, 02896, United States

Location

Vanderbilt Stallworth Rehabilitation Hospital

Nashville, Tennessee, United States

Location

Hospital Hochzirl

Zirl, Austria

Location

St. Mauritius Therapieklinik

Düsseldorf, Germany

Location

Father Muller Medical College

Mangalore, Karnataka, India

Location

All India Institute of Medical Sciences

New Dehli, India

Location

Fondazione Instituto San Raffaele-Giglio

Cefalù, 90015, Italy

Location

University of Salute, San Raffaele Hospital

Milan, Italy

Location

I.R.C.C.S San Camillo

Venezia, Italy

Location

Morinomia Hospital

Osaka, Japan

Location

Federal Medical Center

Abeokuta, Nigeria

Location

Chonnam National Medical School & Hospital

Gwangju, South Korea

Location

University Hospital of Vigo

Vigo, Spain

Location

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bruce H Dobkin, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 11, 2011

Record last verified: 2009-07

Locations

DE(1)IN(2)KR(1)TU(2)ES(1)JP(1)IT(3)US(11)NG(1)AU(1)