Rehabilitation Robotics and Prosthetics Testbed
Tampa, Florida, 33617, United States
NCT Number: NCT01932892
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Tampa, Florida, 33617, United States
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:
o The Range of Motion (ROM) trials include shoulder flexion/extension, shoulder abduction/adduction, and shoulder rotation. Each RoM task will be repeated three times.
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:
o The RoM trials include shoulder flexion/extension, shoulder abduction/adduction, shoulder rotation, and elbow flexion/extension. Each RoM task will be repeated three times.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 hours
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.
Time frame: 3 hours
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.
Time frame: 3 hours
It is predicted that the range of motion of the shoulder will be statistically the same between the original and duplicate socket.
University of South Florida
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06853938
Transhumeral Amputation
Edmonton, Alberta, Canada
View Trial Details