NCT02128152Active, not recruiting
Mobility Training Using Exoskeletons for Functional Recovery After Stroke
Effect of Mobility Training Using Robotic Exoskeletons on Functional Recovery in Individuals With Severe Stroke
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Feb 2014
- Start date
- 1 Feb 2014
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Shirley Ryan AbilityLab
- Diseases
- Stroke
- NCT number
- NCT02128152
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Feb 2014 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
- Untreated deep vein thrombosis (DVT)
Other
- 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)
- Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions and demonstrate learning capability
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rehabilitation Institute of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.