Very Intensive Variable Repetitive AmbulatioN Training

Study Overview
=================
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.

Official Title
-----------------
Very Intensive Variable Repetitive AmbulatioN Training

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 arm RCT - high intensity variable, high intensity forward, low intensity variable
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Variable high-intensity Training<br>high intensity variable stepping exercise on a treadmill and overground | Behavioral: exercise<br>* Variable conditions of stepping practice<br>|
| Active Comparator: Variable low-intensity training<br>low intensity variable stepping exercise on a treadmill and overground | Behavioral: exercise<br>* Variable conditions of stepping practice<br>|
| Active Comparator: Constant High Intensity Training<br>high intensity constant (forward) stepping exercise on a treadmill and overground | Behavioral: exercise<br>* Variable conditions of stepping practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak walking speed | fastest comfortable walking speed overground | At baseline, following 8 weeks of training and a 2 month follow-up | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
locomotion