Transhumeral AmputationNCT01932892
Quantifying Prosthetic Socket Interface Movement
An observational study of Transhumeral Amputation, run by University of South Florida at 1 site in United States.
Trial summary
This study will quantify motion occurring at the socket interface of transhumeral prosthesis users during common tasks. Participants in the study will use a body powered prosthesis with a hosmer hook terminal device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transhumeral Amputation
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Transhumeral amputee
- Uses prosthesis
- Used same socket without documented skin condition for at least 2 months
Who cannot join
- Current skin condition on part of residual limb
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Robotics and Prosthetics Testbed
Tampa, Florida, 33617
About this study
This study will quantify motion occurring at the socket interface of transhumeral prosthesis users during common tasks. Participants in the study will use a body powered prosthesis with a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded into the socket wall will record the amount of movement between the residual limb and socket of the prosthesis. Participants will complete range of motion and functional tasks. The range of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion. The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is expected that the more weight at the terminal device the more rotation at the interface, as well as more slip between residual limb and device. It is also expected that the soft tissues of the residual limb can be modeled as a nonlinear spring and the amount of movement at the interface can be predicted based off the force in the system.
Read the detailed description
Participation in the study will begin at the socket duplication stage/initial testing phase and end no more than a week later after the second collection day is complete. Subjects will meet individually with the PI at lab on testing day one to have their socket duplicated and do some initial testing. Socket duplication will consist of filling the inside volume of the socket with a plaster mixture to form a positive mold. Once set, this positive mold can be removed and used by a contractor to form the clear thermoplastic socket over it. After the mold has been made, the subject will perform a series of tasks while being recorded by an 8 camera Vicon motion analysis system and 2 digital video cameras. Thirty reflective markers will be placed on the subject using an adhesive collar. There is slight risk of skin irritation due to the adhesive tape, similar to wearing a Band-Aid. Some discomfort may arise while removing the markers. A tight fitting shirt will be worn by participants to limit undesired motion of the markers due to loose clothing. Subjects will complete:
- Range of Motion Trials (without prosthesis)
- The Range of Motion (ROM) trials include shoulder flexion/extension, shoulder abduction/adduction, and shoulder rotation. Each RoM task will be repeated three times.
- Trinity Amputation and Prosthesis Experience Scales (TAPES)
- This questionnaire looks at different aspects of having and using a prosthesis.
- Results of this questionnaire will be compared to performance in the laboratory setting to see the correlation between how the user rates the device and how the perform with it.
The first collection day will last about 1-2 hours. For the second collection day, subjects will be randomized into group A or B to determine the order of sockets tested during data collection on the second day. Subjects in group A will use their original prosthesis in the first collection while group B subjects will use their duplicate socket prosthesis. Subjects will switch to the other socket for the second collection session. The second day is expected to last about 3-4 hours. Each session will consist of the following:
- Range of Motion Trials (with prosthesis)
- The RoM trials include shoulder flexion/extension, shoulder abduction/adduction, shoulder rotation, and elbow flexion/extension. Each RoM task will be repeated three times.
- Functional Tasks
- Unilateral lift
- Subject will pick and place a series of weights from one spot on a 3' high shelf to another spot 3' away on the same shelf. The participant must hold the object above the shelf (cannot drag the object) during the transfer and the weight of the object will be varied from 5 to 25lbs in 5lbs increments.
- Amount of movement at the socket interface and time to complete each transfer will be evaluated using this task. We expect that more socket interface movement will
- Bilateral lift
- Subject will lift a basket containing a series of weights from the floor to a 3' high shelf, and then back to the original position. The weight in the basket will be varied from 10 to 50lbs in 10lbs increments.
- Maximum load transferred, and time to complete each transfer will be evaluated using this task. We expect time to complete task will translate to ability to appropriately position the devise. Weight lifted serve as a strength control for the unilateral lift.
- Walk and Carry
- Participants will walk on a treadmill for 1 minute while carrying a 15 pound bag.
- The amount of slip and socket rotation will be recorded.
- Cut play-dough with knife and fork
- Participants sit in front of a table with a plate of play-dough. Participants will be allowed to pick up and use the knife and fork however they desire, but must cut the play dough into three roughly even pieces. This task will be repeated 3 times.
- The time to complete the task, and which hand is used to hold the knife, will be used to determine capability for dexterous manipulation.
- Folding a towel
- Participants will stand before a bath towel laid flat on a table. Subjects will fold the towel in half lengthwise, then in half widthwise, then in half lengthwise. This task will be repeated 3 times.
- The time to complete the task will be used to determine capability for dexterous manipulation.
- Modified Box and Blocks Test
- 16 blocks will be placed in 4 rows on one side of a box with a partition in the middle. The objective is to move one block at a time to the other side going over the partition. Participants will be instructed to start at the lower right corner and complete that row before moving to the next. Subjects will move each block to the matching spot on the opposite half of the box. Participants will have 1 minute to move as many blocks as they can. Participants will repeat this task 4 times. The box will start placed so the blocks start on the same side as the participants prosthesis.
- Outcomes from this test will include the number of blocks moved in the allotted time or the time required to move all 16 blocks, whichever occurs first.
- Conditions
- Transhumeral Amputation
- Keywords
- transhumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transhumeral prosthesis user | Transhumeral body-powered prosthesis user |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of prosthetic socket rotation and slip
Motion capture data and optical sensor data will be used to calculate the amount of prosthetic socket rotation and slip. It is predicted that current socket designs will have some degree of socket movement during normal activities due to soft tissue deformation.
Measured: 3 hours
Secondary outcomes (3)
Magnitude of prosthetic socket movement relative to end effector loading
Motion capture data and optical sensor data will be used to calculate the amount of socket movement compared to the terminal device loading for the various tasks. It is predicted that tasks which have more load at the terminal device will result in more socket movement.
Measured: 3 hours
Magnitude of prosthetic socket movement relative to the amount of residual limb rotation.
The amount of socket movement will be compared to the amount of residual limb rotation for each task. Residual limb rotation is the angle between the upper arm segment and the scapula segment. It is hypothesized the greater the residual limb angle, the greater the amount of socket movement.
Measured: 3 hours
Difference in range of motion of the shoulder joint between no prosthesis, the original prosthetic socket, and the duplicate socket
It is predicted that the range of motion of the shoulder will be statistically the same between the original and duplicate socket.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transhumeral 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Carey, PhD, Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932892
- Sponsor's protocol ID
- 20130075
- Status last verified
- Jun 2014
- First submitted
- 8 May 2013
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Prosthetic Socket Interface Movement
- ClinicalTrials.gov ID
- NCT01932892
- Acronym / sponsor ID
- 20130075
- Conditions
- Transhumeral Amputation
- Keywords
- transhumeral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Aug 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.
This study will quantify motion occurring at the socket interface of transhumeral prosthesis users during common tasks. Participants in the study will use a body powered prosthesis with a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded into the socket wall will record the amount of movement between the residual limb and socket of the prosthesis. Participants will complete range of motion and functional tasks. The range of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion. The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is expected that the more weight at the terminal device the more rotation at the interface, as well as more slip between residual limb and device. It is also expected that the soft tissues of the residual limb can be modeled as a nonlinear spring and the amount of movement at the interface can be predicted based off the force in the system.
Detailed description
Participation in the study will begin at the socket duplication stage/initial testing phase and end no more than a week later after the second collection day is complete. Subjects will meet individually with the PI at lab on testing day one to have their socket duplicated and do some initial testing. Socket duplication will consist of filling the inside volume of the socket with a plaster mixture to form a positive mold. Once set, this positive mold can be removed and used by a contractor to form the clear thermoplastic socket over it. After the mold has been made, the subject will perform a series of tasks while being recorded by an 8 camera Vicon motion analysis system and 2 digital video cameras. Thirty reflective markers will be placed on the subject using an adhesive collar. There is slight risk of skin irritation due to the adhesive tape, similar to wearing a Band-Aid. Some discomfort may arise while removing the markers. A tight fitting shirt will be worn by participants to limit undesired motion of the markers due to loose clothing. Subjects will complete:
- Range of Motion Trials (without prosthesis)
- The Range of Motion (ROM) trials include shoulder flexion/extension, shoulder abduction/adduction, and shoulder rotation. Each RoM task will be repeated three times.
- Trinity Amputation and Prosthesis Experience Scales (TAPES)
- This questionnaire looks at different aspects of having and using a prosthesis.
- Results of this questionnaire will be compared to performance in the laboratory setting to see the correlation between how the user rates the device and how the perform with it.
The first collection day will last about 1-2 hours. For the second collection day, subjects will be randomized into group A or B to determine the order of sockets tested during data collection on the second day. Subjects in group A will use their original prosthesis in the first collection while group B subjects will use their duplicate socket prosthesis. Subjects will switch to the other socket for the second collection session. The second day is expected to last about 3-4 hours. Each session will consist of the following:
- Range of Motion Trials (with prosthesis)
- The RoM trials include shoulder flexion/extension, shoulder abduction/adduction, shoulder rotation, and elbow flexion/extension. Each RoM task will be repeated three times.
- Functional Tasks
- Unilateral lift
- Subject will pick and place a series of weights from one spot on a 3' high shelf to another spot 3' away on the same shelf. The participant must hold the object above the shelf (cannot drag the object) during the transfer and the weight of the object will be varied from 5 to 25lbs in 5lbs increments.
- Amount of movement at the socket interface and time to complete each transfer will be evaluated using this task. We expect that more socket interface movement will
- Bilateral lift
- Subject will lift a basket containing a series of weights from the floor to a 3' high shelf, and then back to the original position. The weight in the basket will be varied from 10 to 50lbs in 10lbs increments.
- Maximum load transferred, and time to complete each transfer will be evaluated using this task. We expect time to complete task will translate to ability to appropriately position the devise. Weight lifted serve as a strength control for the unilateral lift.
- Walk and Carry
- Participants will walk on a treadmill for 1 minute while carrying a 15 pound bag.
- The amount of slip and socket rotation will be recorded.
- Cut play-dough with knife and fork
- Participants sit in front of a table with a plate of play-dough. Participants will be allowed to pick up and use the knife and fork however they desire, but must cut the play dough into three roughly even pieces. This task will be repeated 3 times.
- The time to complete the task, and which hand is used to hold the knife, will be used to determine capability for dexterous manipulation.
- Folding a towel
- Participants will stand before a bath towel laid flat on a table. Subjects will fold the towel in half lengthwise, then in half widthwise, then in half lengthwise. This task will be repeated 3 times.
- The time to complete the task will be used to determine capability for dexterous manipulation.
- Modified Box and Blocks Test
- 16 blocks will be placed in 4 rows on one side of a box with a partition in the middle. The objective is to move one block at a time to the other side going over the partition. Participants will be instructed to start at the lower right corner and complete that row before moving to the next. Subjects will move each block to the matching spot on the opposite half of the box. Participants will have 1 minute to move as many blocks as they can. Participants will repeat this task 4 times. The box will start placed so the blocks start on the same side as the participants prosthesis.
- Outcomes from this test will include the number of blocks moved in the allotted time or the time required to move all 16 blocks, whichever occurs first.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transhumeral prosthesis user | – | –Transhumeral body-powered prosthesis user |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Transhumeral amputee
- Uses prosthesis
- Used same socket without documented skin condition for at least 2 months
Key exclusion criteria (1 listed)
- Current skin condition on part of residual limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Magnitude of prosthetic socket rotation and slip
Time frame: 3 hours
Motion capture data and optical sensor data will be used to calculate the amount of prosthetic socket rotation and slip. It is predicted that current socket designs will have some degree of socket movement during normal activities due to soft tissue deformation.
3 secondary outcomes
Magnitude of prosthetic socket movement relative to end effector loading
Time frame: 3 hours
Magnitude of prosthetic socket movement relative to the amount of residual limb rotation.
Time frame: 3 hours
Difference in range of motion of the shoulder joint between no prosthesis, the original prosthetic socket, and the duplicate socket
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Center for Assistive Rehabilitation Robotic TechnologiesLink provided by the sponsor.
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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.
Stephanie Carey, PhD study director
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?
An observational study of Transhumeral 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 3 inclusion and 1 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 20 Jun 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Magnitude of prosthetic socket rotation and slip (time frame: 3 hours). 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 20 Jun 2014.