Task-oriented Training for Stroke: Impact on Function Mobility

NCT01322607 | Completed Results DMC

• 1 other identifier: O7194-W
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.

Conditions

Cerebrovascular Accident; Stroke

Keywords

Exercise; Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (1)

• Economy of Gait

  Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.

  3 months

Secondary Outcomes (3)

• Muscular Strength

  3 months

• Muscular Endurance

  3 months

• Balance

  3 months

Study Arms (2)

Arm 1: High-Intensity Program

OTHER

High-intensity treadmill-based exercise

Behavioral: High-intensity Treadmill Exercise

Arm 2: Low-Intensity Program

OTHER

Low-intensity lifestyle intervention (group exercise)

Behavioral: Low-intensity Lifestyle Intervention

Interventions

High-intensity Treadmill Exercise BEHAVIORAL

High-intensity treadmill walking program

Arm 1: High-Intensity Program

Low-intensity Lifestyle Intervention BEHAVIORAL

A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.

Arm 2: Low-Intensity Program

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke \> 6 months prior with residual hemiparetic gait in women or men aged 40-85 years.
• Completion of all regular post-stroke physical therapy
• Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent.
• Able to rise from a chair unaided.
• Able to walk 10 meters without human assistance.

You may not qualify if:

• Regular structured aerobic exercise (\> 2x week).
• Alcohol consumption \> 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report.
• Clinical history of
• unstable angina,
• recent (\< 3 months) myocardial infarction or congestive heart failure (NYHA category II),
• hemodynamically significant valvular dysfunction,
• Peripheral Arterial Obstructive Disease with claudication,
• major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise,
• pulmonary or renal failure,
• poorly controlled hypertension (\>190/110), measured on at least two separate occasions
• recent hospitalization for severe disease or surgery
• severe or global receptive aphasia which confounds reliable testing and training.
• Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of \>16 and confirmed by clinical interview.
• Pregnancy.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• Liu X, Zhang Y, Li F, Liu L, Du J, Song WQ. Test-retest reliability and practice effects of shape trail test in stroke patients. Top Stroke Rehabil. 2025 Oct;32(7):779-788. doi: 10.1080/10749357.2025.2457282. Epub 2025 Mar 13.

  PMID: 40079581 DERIVED

• Stookey AD, Macko RF, Ivey FM, Katzel LI. Evaluating Test-Retest Reliability of Fatigability in Chronic Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105895. doi: 10.1016/j.jstrokecerebrovasdis.2021.105895. Epub 2021 Jul 7.

  PMID: 34242857 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Research Specilist
• Organization: Baltimore VA Medical Center (VAHMCS)

alyssa.stookey@va.gov

410-605-7156

Study Officials

• Alyssa D Stookey, PhD MS

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 6, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-03

Locations

US (1)