Locomotor Training (Walking Therapy) Post Stroke

NCT00715299 | Completed Results

• 1 other identifier: B3983-R
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to examine a new type of walking therapy for people after they have had a stroke. We will study how people move and how their muscles work to see how the therapy helps people to walk better and to see how the therapy can be improved.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.

  Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.

  Pre and post Treatment

Study Arms (1)

Locomotor Training Group

OTHER

persons who have sustained a stroke within greater than 6 months ago and less than 5 years.

Behavioral: locomotor training

Interventions

locomotor training BEHAVIORAL

Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.

Locomotor Training Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18,
• stroke within past 6 months to 5 years,
• residual paresis in the lower extremity (Fugl-Meyer LE motor score \< 34),
• ability to sit unsupported for 30 seconds,
• ability to walk at least 10 feet with maximum 1 person assist,
• self selected 10 meter gait speed less than 0.8 m/s,
• ability to follow a three step command,
• provision of informed consent, and
• successful completion of an exercise tolerance test

You may not qualify if:

• Lived in nursing home prior to stroke,
• Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters,
• Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded,
• History of serious chronic obstructive pulmonary disease or oxygen dependence,
• Severe weight bearing pain,
• Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, or previous stroke with residual neurological deficits,
• History of major head trauma,
• Lower extremity amputation,
• Non-healing ulcers on the lower extremity,
• Renal dialysis or end stage liver disease,
• Legal blindness or severe visual impairment,
• A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, schizophrenia or medication refractory depression,
• Life expectancy less than one year,
• Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10, knee flexion ROM \< 90, hip flexion contracture \> 25, and ankle plantar flexion contracture \> 15,
• History of sustained alcoholism or drug abuse in the last six months,

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Steve Kautz, PhD, Principal Investigator
• Organization: VAHSRD and Medical University of South Carolina

kautz@musc.edu

843-792-3867

Study Officials

• Steve A. Kautz, PhD MS BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 15, 2008
• Study Start: June 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 5, 2015
• Results First Posted: March 5, 2015

Record last verified: 2015-02

Locations

US (1)