Strength Training Effectiveness Post-Stroke (STEPS)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00389012
• Date of registration: 16/10/2006
• Primary sponsor: University of Southern California
• Public title: Strength Training Effectiveness Post-Stroke (STEPS)
• Scientific title: Strength Training Effectiveness Post-Stroke (STEPS)
• Date of first enrolment: May 2004
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00389012
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David A Brown, PhD, PT
• Affiliation: Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

• Name: Katherine J Sullivan, PhD, PT
• Affiliation: Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California

• Name: Sara Mulroy, PhD, PT
• Affiliation: Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebrovascular Accident

Intervention(s)

Procedure: exercise therapy

Procedure: walking rehabilitation

Primary Outcome(s)

walking distance (distance walked in 6-minutes)

walking speed (meters/second)

Secondary Outcome(s)

Berg Balance Score

Lower extremity Fugl-Meyer

Lower extremity torque

SF-36

Stroke Impact Scale

Secondary ID(s)

025024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Physical Therapy Clinical Research Network