Strength Training Effectiveness Post-Stroke (STEPS)

Cerebrovascular Accident Clinical Trial

Official title:

Strength Training Effectiveness Post-Stroke (STEPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389012
• Other study ID #: 025024
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2006
• Last updated: April 4, 2017
• Start date: May 2004
• Est. completion date: October 31, 2010

Study information

• Verified date: April 2010
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2010
• Est. primary completion date: October 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Procedure:
• exercise therapy

• walking rehabilitation

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Rancho Los Amigos	Downey	California
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Physical Therapy Clinical Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking speed (meters/second)
Primary	walking distance (distance walked in 6-minutes)
Secondary	Lower extremity Fugl-Meyer
Secondary	Berg Balance Score
Secondary	Lower extremity torque
Secondary	Stroke Impact Scale
Secondary	SF-36