Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation

ConditionsAmputation Prosthesis Use

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVirginia Commonwealth University

About this trial

Different ways of controlling an upper-limb prosthesis can affect how easy it is to use and how helpful it is in everyday activities. One common method, called direct control, uses signals from two muscles and can make switching between movements difficult. Another clinically available option, called pattern recognition control, uses signals from several muscles to better understand the user's intended movement and may feel more natural to use. This study compares these two control methods to see how they affect function for adults with below-the-elbow limb loss.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Unilateral transradial limb loss

At least 6 months since loss

Previous or current use of a myoelectric device for 3 months or longer

Disqualifiers

Any health condition that would prevent safely completing trial activities

Discontinued use of a myoelectric prosthesis due to non-financial reasons

Trial design

Design model

Crossover

Treatments tested in this trial

Training with PRC
Device
All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).
Training with DC
Device
All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).
PRC Device use in community and home
Device
After the training sessions, all subjects will use the PRC device in their homes, just in a different order.
DC Device use in community and home
Device
After the training sessions, all subjects will use the DC device in their homes, just in a different order.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Pattern recognition controller (PRC) arm method intervention first and then the DC interventionActive comparator 4 interventions

Group B: DC intervention first and then the Pattern recognition controller (PRC) arm method interventionActive comparator 4 interventions

Trial outcomes

Primary outcomes

Refined Clothespin Relocation Test (rCRT)

The rCRT measures upper limb prosthesis performance. The test requires participants to rotate each clothespin 90° before placing it onto the vertical bar, which necessitates use of more than one joint motion. Faster completion times are indicative of superior prosthesis control and dexterity.

Time frame