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

Conditions

• Amputation
• Prosthesis Use

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Pattern recognition controller (PRC) arm method intervention first and then the DC intervention
  Participants randomized to this condition will first try the PRC controller for 3 months. Afterwards, participants will try the DC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
• Active Comparator: DC intervention first and then the Pattern recognition controller (PRC) arm method intervention
  Participants randomized to this condition will first try the DC controller for 3 months. Afterwards, participants will try the PRC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.

Primary Outcome Measure

Refined Clothespin Relocation Test (rCRT) [ Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments ]

Central Contacts

• Shane R. Wurdeman, PhD
  281-829-4746
  [email protected]
• Bretta L. Fylstra, PhD
  512-994-6685
  [email protected]

Locations (2)

Find similar trials in Austin, TX

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