N/A
N=48
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Cerebrovascular Accident (CVA) · Stroke · Hemiplegia
Bottom Line
View on ClinicalTrials.gov: NCT03054064 ↗Enrolled (actual)
48
Serious AEs
6.3%
Results posted
Apr 2020
Primary outcome: Primary: Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events — 3; 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indego Exoskeleton (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Parker Hannifin Corporation
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events |
3; 0 | — |
| SECONDARY Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Activity Measured by Functional Ambulation Category |
5; 5 | — |
| SECONDARY Gait Speed (Without Indego) Measured With 10 Meter Walk Test |
24.4; 19.4 | — |
| SECONDARY Pain Measured With Face, Legs, Activity, Cry, Consolability Scale |
0; 0 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03054064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.