The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.
This study will systematically compare various commercially available REs and aid in identifying the appropriate devices for gait training prescription in individuals post-stroke based on their deficits. The objective of this study is to evaluate and compare the four groups (3 REs and standard of care treatment) using biomechanical, functional and community participation \& quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
Standard of Care
Kessler Foundation
West Orange, New Jersey, United States
RECRUITING10MWT (Aim 1)
10 meter walk test to evaluate walking speed after stroke and in response to the intervention.
Time frame: Change from Baseline 10MWT at 4 weeks
6MWT (Aim 1)
6 minute walking test to evaluate endurance after stroke and in response to the intervention
Time frame: Change from Baseline 6MWT at 4 weeks
TUG (Aim 1)
Timed up and go (TUG) test to measure functional balance and walking ability after stroke and in response to the intervention.
Time frame: Change from Baseline TUG at 4 weeks
DGI (Aim 1)
Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after stroke and in response to the intervention.
Time frame: Change from Baseline DGI at 4 weeks
Berg Balance Scale (Aim 1)
Measure to assess static and dynamic balance and fall risk after stroke and in response to the intervention.
Time frame: Change from Baseline Berg at 4 weeks
Joint Range of Motion (kinematics) (Aim 2)
Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes.
Time frame: Change from Baseline at 4 weeks
Temporospatial Loading (Aim 2)
Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and insoles.
Time frame: Change from Baseline at 4 weeks
Balance (Aim 2)
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Static and dynamic balance in standing and seated positions after stroke and in response to the intervention (using Hunova (Movendo Inc, Genova, Italy) plaform).
Time frame: Change from Baseline at 4 weeks
Survey for Community Participation (Aim 3)
The Community Participation Indicators (CPI) is a self-reported 48 item objective measure survey.
Time frame: Change from Baseline at 4 weeks
Survey for Quality of Life (Aim 3)
The SS-QOL survey assesses health-related quality of life (QOL) specific to stroke survivors with 49 items across 12 domains.
Time frame: Change from Baseline at 4 weeks