Below Elbow AmputationRFIDIBTNCT01967004
Enhancing Upper Limb Prostheses With Radio Frequency Identification
A study testing Morph in people with Below Elbow Amputation, run by Infinite Biomedical Technologies at 2 sites in United States.
Trial summary
The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Below Elbow Amputation
- What is being tested?
- Morph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or greater.
- Below elbow amputation, unilateral or bilateral.
- Chronic stable amputation: > 6 months from amputation.
- Stable prosthesis prescription: > 3 months since last major prosthesis modification.
- Cognitively intact, as determined by Mini-Mental Status Examination score > 24.
- Able to provide informed consent and available to participate in study activities.
- No severe residual limb motor/sensory impairment or pain likely to interfere with treatment.
- Expected to be medically and psychiatrically stable for study duration.
Who cannot join
- Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.
- Patients with poor skin integrity.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Eastern Campus
Baltimore, Maryland, 21218-3637
Johns Hopkins Eastern Campus
Baltimore, Maryland, 21218
About this study
Official title: Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)
The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.
- Conditions
- Below Elbow Amputation
- Being tested
- Morph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphDevice
Also called Myoelectrically-Operated RFID Prosthetic Hand
Morph is a small electric controller that is retrofit into existing myoelectric prostheses to equip them with wireless identification capabilities. Specifically, Morph allows the prosthesis to react to RFID tags in the environment.
| Study group | Role | What they receive |
|---|---|---|
| Functional Assessment | Experimental | Participant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects. Receives: Device: Morph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to perform different functional tasks
Each participant will perform functional tests on the first visit. These tests consist of moving objects from one location to another, and performing certain muscle contraction patterns when prompted. The participant will then take the prosthesis, installed with morph, home for 3 months at most, and then return to perform another set of timed trials.
Measured: 12 weeks
Secondary outcomes (1)
Questionnaires on prosthesis function and satisfaction
The questionnaires offer the participant the opportunity to express their experience and satisfaction with their prosthesis, during different tasks and at home.
Measured: 20 minutes per questionnaire, total of 3 different questionnaires administered twice each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Below Elbow AmputationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infinite Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967004
- Sponsor's protocol ID
- RFID-IBT-3600
- Acronym
- RFIDIBT
- Status last verified
- Oct 2013
- First submitted
- 26 Sep 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)
- ClinicalTrials.gov ID
- NCT01967004
- Acronym / sponsor ID
- RFIDIBT / RFID-IBT-3600
- Conditions
- Below Elbow Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Infinite Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
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 determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Assessment | Experimental | Device: MorphParticipant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or greater.
- Below elbow amputation, unilateral or bilateral.
- Chronic stable amputation: > 6 months from amputation.
- Stable prosthesis prescription: > 3 months since last major prosthesis modification.
- Cognitively intact, as determined by Mini-Mental Status Examination score > 24.
Key exclusion criteria (2 listed)
- Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.
- Patients with poor skin integrity.
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 |
|---|---|---|
| MorphAlso: Myoelectrically-Operated RFID Prosthetic HandMorph is a small electric controller that is retrofit into existing myoelectric prostheses to equip them with wireless identification capabilities. Specifically, Morph allows the prosthesis to react to RFID tags in the environment. | Device | Functional Assessment |
Primary outcome
Time required to perform different functional tasks
Time frame: 12 weeks
Each participant will perform functional tests on the first visit. These tests consist of moving objects from one location to another, and performing certain muscle contraction patterns when prompted. The participant will then take the prosthesis, installed with morph, home for 3 months at most, and then return to perform another set of timed trials.
1 secondary outcome
Questionnaires on prosthesis function and satisfaction
Time frame: 20 minutes per questionnaire, total of 3 different questionnaires administered twice each
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morph in people with Below Elbow Amputation, run by Infinite Biomedical Technologies at 2 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
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?
Time required to perform different functional tasks (time frame: 12 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 5 Mar 2014.