Mobility Training Using Exoskeletons for Functional Recovery After Stroke

Running, not enrolling · Not applicable

Conditions studied: Severe Stroke or Similar Neurological Muscle Weakness

In brief

The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke. * Primary Objectives: * To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking recovery in individuals affected by severe stroke. * To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and severity (non-ambulators vs. limited house-hold ambulators) affects the improvement in gait speed and overall function following the EXTP training protocol. * To determine whether maintenance or further improvement in gait speed can be achieved by an intensive follow-up program of either a traditional rehabilitation program (TRP) or extended EXTP. * Secondary Objectives: * To determine the effect on functional walking endurance as assessed by the 6 minute walk test and 10 meter walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. * To determine the effect on functional balance, as assessed by the Berg Balance Scale, Functional Gait Assessment and Five times sit to stand measure as assessed by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. * To determine the effect on stroke recovery, as assessed by the step counter of task specific training in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting

Key facts

Study ID: NCT02128152
Run by: Shirley Ryan AbilityLab
People needed: 60
Starts: 2014-02-01
Expected to finish: 2025-12-01
Last updated by the study team: 2025-04-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must be post stroke or have similar neurological weakness (2 weeks up to 6 months post and 6 months or more post)
Subjects must be between 18-85 years of age
Subjects must be able to fit into device and have joint motion to allow ambulation in device
Subjects must be able to tolerate upright standing for 30 minutes
Subjects must have sufficient upper extremity strength and balance to allow ambulation with device
Subjects must have walking speed <0.4m/s, including non-ambulators
Subjects must be able and willing to give written consent and comply with study procedures, including follow-up visits
Mini Mental Status Exam (MMSE) score >17
Medical clearance from physician

You may not qualify if…

Subjects must not be shorter than 60 inches or taller than 74 inches
Subjects must not weight greater than 220 lbs
Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation
Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions and demonstrate learning capability
Pregnancy
Untreated deep vein thrombosis (DVT)

Where it is running

Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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