Spinal Cord InjuriesNCT03696927
Active Powered Prosthesis (APEX) for Spinal Cord Injury
A study testing Active Powered Prosthesis (APEX) for Spinal Cord Injury in people with Spinal Cord Injuries, run by AbiliTech Medical Inc. at 1 site in United States.
Trial summary
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Active Powered Prosthesis (APEX) for Spinal Cord Injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 29 Aug 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
- Spinal cord injury at levels C3 to C5, and AIS A, B, or C
- Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
- Ability to provide informed consent
- Age 18 or over
- Selected for participation based on investigator discretion
Who cannot join
- Unable to follow instructions
- Exhibit significant behavioral problems or impaired cognitive ability
- Inability to provide consent
- Non-English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Allina Health Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, 55407
About this study
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. The objective of this study is to perform focus groups with users and clinicians to evaluate a proof of concept active powered assistance device.
- Conditions
- Spinal Cord Injuries
- Being tested
- Active Powered Prosthesis (APEX) for Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Powered Prosthesis (APEX) for Spinal Cord InjuryDevice
The Active Powered Prosthesis (APEX) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Focus group participants will control the APEX device on a test manikin and provide feedback on the device design and function.
| Study group | Role | What they receive |
|---|---|---|
| User Focus Group Participants | Experimental | Target user population will be human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C. Receives: Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Ability to Operate the APEX Device
Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
Measured: Two hours of in-clinic prototype evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start29 Aug 2018
- Primary completion29 Aug 2018
- Study completion29 Aug 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 Spinal Cord InjuriesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbiliTech Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allina Health System, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jennifer L Theis, MS, OT/L, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696927
- Sponsor's protocol ID
- 6100003-100 Rev A
- Other IDs
- R43HD094440
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2018
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Powered Prosthesis (APEX) for Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03696927
- Acronym / sponsor ID
- 6100003-100 Rev A
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AbiliTech Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Allina Health System, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 15 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. The objective of this study is to perform focus groups with users and clinicians to evaluate a proof of concept active powered assistance device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| User Focus Group Participants | Experimental | Device: Active Powered Prosthesis (APEX) for Spinal Cord InjuryTarget user population will be human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spinal cord injury at levels C3 to C5, and AIS A, B, or C
- Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
- Ability to provide informed consent
- Age 18 or over
- Selected for participation based on investigator discretion
Key exclusion criteria (4 listed)
- Unable to follow instructions
- Exhibit significant behavioral problems or impaired cognitive ability
- Inability to provide consent
- Non-English speaker
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 |
|---|---|---|
| Active Powered Prosthesis (APEX) for Spinal Cord InjuryThe Active Powered Prosthesis (APEX) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Focus group participants will control the APEX device on a test manikin and provide feedback on the device design and function. | Device | User Focus Group Participants |
Primary outcome
User Ability to Operate the APEX Device
Time frame: Two hours of in-clinic prototype evaluation
Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jennifer L Theis, MS, OT/L principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Powered Prosthesis (APEX) for Spinal Cord Injury in people with Spinal Cord Injuries, run by AbiliTech Medical Inc. at 1 site 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 5 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 15 Nov 2022). 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?
User Ability to Operate the APEX Device (time frame: Two hours of in-clinic prototype evaluation). 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 15 Nov 2022.