Very Intensive Variable Repetitive AmbulatioN Training

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: exercise

• Registration Number: NCT02507466
• Lead Sponsor: Shirley Ryan AbilityLab

Brief Summary

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.

Detailed Description

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the independent and combined (paired) contributions of intensity and variability of stepping training on locomotor function, with secondary measures of health and community mobility. For Aim 2, we will evaluate the independent and combined effects of intensity and variability of stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness of providing these interventions to accelerate motor recovery and health. Our central hypothesis is that results of this study will provide a theoretical foundation for implementation of physical therapy interventions which can facilitate short-term gains in locomotor function, and contribute to long-term improvements in health, function and participation through increased community mobility.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• history unilateral stroke > 6 months duration
• walks without physical assistance at speeds < 1.0 m/s

Exclusion Criteria

• no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Variable high-intensity Training	exercise	high intensity variable stepping exercise on a treadmill and overground
Constant High Intensity Training	exercise	high intensity constant (forward) stepping exercise on a treadmill and overground
Variable low-intensity training	exercise	low intensity variable stepping exercise on a treadmill and overground

Primary Outcome Measures

Name	Time	Method
Change in peak walking speed	At baseline, following 8 weeks of training and a 2 month follow-up	fastest comfortable walking speed overground

Secondary Outcome Measures

Name	Time	Method
Change in 5X sit-to-stand transfer time	At baseline, following 8 weeks of training and a 2 month follow-up	non-walking functional mobility task
Change in Functional Gait Assessment	At baseline, following 8 weeks of training and a 2 month follow-up	dynamic balance activities

Trial Locations

Locations (1)

Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States