The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device.
Traditional physical therapist driven gait training.
Kessler Foundation
West Orange, New Jersey, United States
Functional Independence Measure (FIM)
a conventional assessment measure of motor function
Time frame: 6 months
TUG
time up and go (TUG) test
Time frame: 6 months
BBA
Berg Balance Assessment (BBA)
Time frame: 6 months
ROM
range of motion (ROM)- conventional assessment performed by a physical therapist
Time frame: 6 months
strength
conventional assessment performed by a physical therapist
Time frame: 6 months
temporal spatial parameters
collected though motion capture camera system
Time frame: 6 months
plantar loading
use of shoe insoles to gather information about foot pressure
Time frame: 6 months
electromyography (EMG)
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
Time frame: 6 months
SIS
stroke impact scale (SIS). questionnaire about quality of life post-stroke
Time frame: 6 months
LIFE-H
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
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Time frame: 6 months
SSQoL
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
Time frame: 6 months