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Completed

NCT Number: NCT00389012

Strength Training Effectiveness Post-Stroke (STEPS)

The purpose of this study is to determine if treadmill training with body weight-support (BWST) is more effective at improving walking in individuals post-stroke than a resisted leg-cycling exercise program. In addition, we want to determine if training programs that combine leg strength training to treadmill walking provide an additional benefit to post-stroke walking outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rancho Los Amigos, Downey, California, United States

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About this study

Impaired walking ability is a hallmark residual deficit that contributes to post-stroke walking disability . Impairment in lower extremity muscle strength is a significant contributor to decreased walking speed after stroke. No studies have combined task-specific locomotor training in combination with lower extremity strength training programs designed to improve post-stroke walking outcomes.

Participants will include individuals who are ambulatory, but walk slower than 1.0 m/sec and are at least 6 months post unilateral stroke.

Participants are stratified by initial comfortable walking speed (moderate >0.5 m/sec; severe <= 0.5 m/sec) and randomized to one of four exercise pairs: 1) body-weight supported treadmill training (BWST) and locomotor-based strength training (resistive cycling task, LBST), 2) BWST and LE muscle-specific strength training (MSST), 3) BWST and upper extremity ergometry (SHAM), and 4) LBST and SHAM. Training will occur 4 times per week for 6 weeks (24 total sessions). Exercise type in each exercise pair is alternated daily.

Primary outcomes include comfortable and fast overground walking speed, and distance walked in 6-minutes measured at baseline, after 12 and 24 treatment sessions and at a 6-month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 years or older
  • 4 months to 5 years after first-time onset of a ischemic or hemorrhagic cerebrovascular accident (CVA) confirmed by CT, MRI, or clinical criteria
  • able to ambulate at least 14 meters with assistive and/or orthotic device and one person assist (minimum Functional Ambulation Classification Level II
  • self-selected walking velocity of ≤1.0 meters/second
  • approval of primary care physician to participate.

Exclusion criteria

  • resting systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 110mmHg and/or resting heart rate greater than 100 beats/minute;
  • lower limb orthopedic conditions such as prior joint replacement or range of motion limitations;
  • spasticity management that included Botox injection (< 4 months earlier) or phenol block injection (< 12 months earlier) to affected lower extremity and intrathecal Baclofen or oral Baclofen (within past 30 days);
  • Mini-Mental State Exam score < 24;
  • currently receiving lower extremity strengthening exercises or gait training,
  • past participation in any study examining the effects of long term (>4 weeks training) body weight support treadmill training; limb loaded pedaling, or lower extremity strengthening;
  • plans to move out of the area in the next year,
  • no transportation to the study site for all evaluations and intervention sessions.

Treatment and study plan

Exercise therapy

Procedure

walking rehabilitation

Procedure

Primary outcomes

  1. walking speed (meters/second)

  2. walking distance (distance walked in 6-minutes)

Secondary outcomes

  1. Lower extremity Fugl-Meyer

  2. Berg Balance Score

  3. Lower extremity torque

  4. Stroke Impact Scale

  5. SF-36

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Physical Therapy Clinical Research Network

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Oct 17, 2006
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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