NCT03054064CompletedNot Applicable
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Parker Hannifin Corporation14 sites in 1 country48 target enrollmentStarted: February 21, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Parker Hannifin Corporation
- Enrollment
- 48
- Locations
- 14
- Primary Endpoint
- Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length)
- •Weight 250 pounds or less
- •History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis
- •Manual Muscle Test (MMT) 4/5 in at least upper extremity
- •No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training
- •No other brain abnormalities or neurological diseases/disorders
- •Has not been diagnosed with more than one stroke
- •Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait
- •Skin intact where interfaces with Indego device
- •Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities
- •Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training
- •Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater
Exclusion Criteria
- •Failure to meet all inclusion criteria
- •Pregnancy
- •Colostomy bag
- •Uncontrolled/untreated hyper- or hypotension
Outcomes
Primary Outcomes
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Time Frame: 2 weeks
Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events
Secondary Outcomes
- Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale(2 weeks)
- Pain Measured With Face, Legs, Activity, Cry, Consolability Scale(2 weeks)
- Activity Measured by Functional Ambulation Category(2 weeks)
- Gait Speed (Without Indego) Measured With 10 Meter Walk Test(2 weeks)
Investigators
Study Sites (14)
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