Upper Limb AmputationNCT02136238
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
A study testing Hosmer 5XA voluntary opening hook and TRS Grip 3 voluntary closing hook in people with Upper Limb Amputation, run by University of South Florida at 1 site in United States.
Trial summary
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Amputation
- What is being tested?
- Hosmer 5XA voluntary opening hook and TRS Grip 3 voluntary closing hook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2014
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral transradial or wrist-disarticulation amputee
- 18 to 85 years of age
- At least 1 year from date of amputation
- Be able to independently provide informed consent
- Be willing to comply with study procedures Exclusion criteria
- History of acute or chronic skin breakdown on the residual limb
Show all 18Show fewer
- Prosthetic socket adjustment within 90 days
- Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
- Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
- Unwillingness/inability to follow instructions Inclusion criteria for able-bodied subjects
- 18 to 85 years of age
- Able to provide independent, informed consent
- Independent function by self-report
- Free of any health ailment that would impair physical function Exclusion criteria for able-bodied subjects
- Younger than 18 or older than 85 years of age
- Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
- No injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
- Unwillingness/inability to follow instructions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The specific aims of this clinical trial are to:
- Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity.
- Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.
Read the detailed description
To evaluate the performance of the prehensors, subjects will complete a randomized A-B crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.) healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or are interested in using a body-powered prosthesis. We anticipate data collection data with 10 non-amputee subject, and 8 amputee subjects.
- Conditions
- Upper Limb Amputation
- Being tested
- Hosmer 5XA voluntary opening hook, TRS Grip 3 voluntary closing hook
- Keywords
- amputation, transradial, prosthesis, terminal device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hosmer 5XA voluntary opening hookDevice
Voluntary opening prosthetic terminal device ("hand")
TRS Grip 3 voluntary closing hookDevice
Voluntary closing prosthetic terminal device ("hand")
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic hand 1 (Hosmer 5XA) | Active comparator | This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1 Receives: Device: Hosmer 5XA voluntary opening hook |
| Prosthetic hand 2 (TRS Grip 3) | Active comparator | This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2 Receives: Device: TRS Grip 3 voluntary closing hook |
| Non-amputee controls | No intervention | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal Displacement During Towel Folding Task
Distance sternum is displaced while folding a towel was measured in meters.
Measured: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Physical Function Performance 10 Test Score
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
Measured: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionNov 2014
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 Upper Limb AmputationStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida High Tech Corridor Council, TRS, Inc.
- Responsible party
- Principal investigator, Jason Highsmith, University of South Florida
- Investigators
- Jason Highsmith, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136238
- Sponsor's protocol ID
- Pro0013189
- Status last verified
- Dec 2023
- First submitted
- 17 Feb 2014
- Last updated
- 28 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices
- ClinicalTrials.gov ID
- NCT02136238
- Acronym / sponsor ID
- Pro0013189
- Conditions
- Upper Limb Amputation
- Keywords
- amputation, transradial, prosthesis, terminal device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Florida High Tech Corridor Council, TRS, Inc.
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Posted 29 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The specific aims of this clinical trial are to:
- Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity.
- Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.
Detailed description
To evaluate the performance of the prehensors, subjects will complete a randomized A-B crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.) healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or are interested in using a body-powered prosthesis. We anticipate data collection data with 10 non-amputee subject, and 8 amputee subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prosthetic hand 1 (Hosmer 5XA) | Active comparator | Device: Hosmer 5XA voluntary opening hookThis arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1 |
| Prosthetic hand 2 (TRS Grip 3) | Active comparator | Device: TRS Grip 3 voluntary closing hookThis arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2 |
| Non-amputee controls | No intervention | –This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Unilateral transradial or wrist-disarticulation amputee
- 18 to 85 years of age
- At least 1 year from date of amputation
- Be able to independently provide informed consent
- Be willing to comply with study procedures Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hosmer 5XA voluntary opening hookVoluntary opening prosthetic terminal device ("hand") | Device | Prosthetic hand 1 (Hosmer 5XA) |
| TRS Grip 3 voluntary closing hookVoluntary closing prosthetic terminal device ("hand") | Device | Prosthetic hand 2 (TRS Grip 3) |
Primary outcome
Sternal Displacement During Towel Folding Task
Time frame: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Distance sternum is displaced while folding a towel was measured in meters.
Physical Function Performance 10 Test Score
Time frame: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- 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.
Jason Highsmith, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hosmer 5XA voluntary opening hook and TRS Grip 3 voluntary closing hook in people with Upper Limb Amputation, run by University of South Florida 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 18 inclusion and 0 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 28 Dec 2023. 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 29 Apr 2015). 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?
Sternal Displacement During Towel Folding Task (time frame: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.). The study lists 2 primary outcomes in all. 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 28 Dec 2023.