Cerebrovascular Accident (CVA)NCT03054064
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
A study testing Indego Exoskeleton in people with Cerebrovascular Accident (CVA) and Stroke, run by Parker Hannifin Corporation at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident (CVA), Stroke, Hemiplegia
- What is being tested?
- Indego Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Feb 2017to 17 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Failure to meet all inclusion criteria
- Pregnancy
- Colostomy bag
- Uncontrolled/untreated hyper- or hypotension
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Shepherd Center
Atlanta, Georgia, 30309
Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
Chicago, Illinois, 60611
TIRR Memorial Hermann
Houston, Texas, 77030
Cedars-Sinai Health System
Los Angeles, California, 90048
Sheltering Arms Physical Rehabilitation Centers
Mechanicsville, Virginia, 23116
St. Charles Hospital
Port Jefferson, New York, 11777
Kessler Foundation
West Orange, New Jersey, 07052
About this study
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).
- Conditions
- Cerebrovascular Accident (CVA), Stroke, Hemiplegia
- Being tested
- Indego Exoskeleton
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indego ExoskeletonDevice
Six study sessions including five Indego training sessions over two weeks.
| Study group | Role | What they receive |
|---|---|---|
| All Enrolled Subjects | Experimental | All enrolled subjects will receive gait training with the Indego. Receives: Device: Indego Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events
Measured: 2 weeks
Secondary outcomes (4)
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
Spasticity measured with Modified Ashworth Scale (MAS)
0 - No increase in muscle tone
1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 - More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 - Considerable increase in muscle tone, passive movement difficult 4 - Affected part(s) rigid in flexion or extension
Measured: 2 weeks
Activity Measured by Functional Ambulation Category
Activity measured by Functional Ambulation Category (FAC)
- unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from > 1 person
- requires manual contact of one person during ambulation on level surfaces/manual contact is continuous and necessary to support body weight and/or to maintain balance or assist coordination
- requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination
- ambulation occurs on level surfaces without manual contact of another person/requires stand-by guarding of one person because of poor judgment, questionable cardiac status, or the need for verbal cuing to complete the task
- ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces
- ambulation is independent on unlevel and level surfaces, stairs and inclines
Measured: 2 weeks
Gait Speed (Without Indego) Measured With 10 Meter Walk Test
10 Meter Walk Test (MWT) without Indego to measure gait speed
Measured: 2 weeks
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile
- occasional grimace or frown, withdrawn, disinterested
- frequent to constant frown, clenched jaw, quivering chin
Legs 0: normal position or relaxed
- uneasy, restless, tense
- kicking, or legs drawn up
Activity 0: lying quietly, normal position, moves easily
- squirming, shifting back and forth, tense
- arched, rigid, or jerking
Cry 0: no cry (awake or asleep)
- moans or whimpers, occasional complaint
- crying steadily, screams or sobs, frequent complaints
Consolability 0: content, relaxed
- reassured by occasional touching, hugging, or being talked to, distractable
- difficult to console or comfort
Minimum score: 0 Maximum Score: 10
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start21 Feb 2017
- Primary completion28 Dec 2017
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrovascular Accident (CVA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Hannifin Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shepherd Center, Atlanta GA, Cedars-Sinai Medical Center, Sheltering Arms Physical Rehabilitation Hospitals, Shirley Ryan AbilityLab, Kessler Foundation, St. Charles Hospital, TIRR Memorial Hermann, Rusk Rehabilitation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054064
- Sponsor's protocol ID
- PHIND_CVA01
- Status last verified
- Mar 2020
- First submitted
- 13 Feb 2017
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
- ClinicalTrials.gov ID
- NCT03054064
- Acronym / sponsor ID
- PHIND_CVA01
- Conditions
- Cerebrovascular Accident (CVA), Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Parker Hannifin CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Shepherd Center, Atlanta GA, Cedars-Sinai Medical Center, Sheltering Arms Physical Rehabilitation Hospitals, Shirley Ryan AbilityLab, Kessler Foundation, St. Charles Hospital, TIRR Memorial Hermann, Rusk Rehabilitation
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Enrolled Subjects | Experimental | Device: Indego ExoskeletonAll enrolled subjects will receive gait training with the Indego. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- Failure to meet all inclusion criteria
- Pregnancy
- Colostomy bag
- Uncontrolled/untreated hyper- or hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indego ExoskeletonSix study sessions including five Indego training sessions over two weeks. | Device | All Enrolled Subjects |
Primary outcome
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
4 secondary outcomes
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
Time frame: 2 weeks
Activity Measured by Functional Ambulation Category
Time frame: 2 weeks
Gait Speed (Without Indego) Measured With 10 Meter Walk Test
Time frame: 2 weeks
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indego Exoskeleton in people with Cerebrovascular Accident (CVA) and Stroke, run by Parker Hannifin Corporation at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.