Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke

VA Office of Research and Development16 enrolled

Overview

The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.

In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (\>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping. The complete study results are published.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Locomotor trainingBEHAVIORAL

This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of cerebrovascular accident * Single event * Unilateral hemiplegia * Locomotor disability * Ability to walk independently 25' on level ground (may use an assistive device \[cane or walker\]; may NOT use a brace) * Cognitive ability to follow 3-step commands Exclusion Criteria: * Unstable or uncontrolled blood pressure * Uncontrolled seizures * Severe cognitive impairment

Locations (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Self-selected Overground Walking Speed

Overground walking speed determined as rate of walking over a 10 meter distance.

Time frame: 4 weeks (s/p 12 sessions of locomotor training)

Secondary Outcomes

Fast Walking Speed

Fastest comfortable walking speed measured while walking overground

Time frame: 4 weeks (s/p 12 training sessions)

Six Minute Walk

distance, in meters, walked overground over a six minute interval.

Time frame: 4 weeks

Step Length Ratio (Abs)

measure of step length symmetry, calculated as = ABS \[1 - (Pstep length / NPstep length)\]

Time frame: 4 weeks

Lower Extremity Fugl-Meyer Motor Assessment

Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.

Time frame: 4 weeks

Short Physical Performance Battery

Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.

Time frame: 4 weeks

Berg Balance Scale

Clinical measure of balance

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.