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Functional Importance of a Powered Multifunction Wrist Protocol

NCT04069793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-07-04

No results posted yet for this study

Summary

The focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. This study will enable the investigator to quantify the relative functional value of powered wrist flexion during both in-laboratory testing and home use. In addition, the investigators will address the effectiveness of different hand-wrist combinations to enhance patient-centered clinical decision making.

Conditions

  • Upper Limb Amputation at the Hand
  • Upper Limb Amputation at the Wrist
  • Amputation
  • Amputation; Traumatic, Limb

Interventions

DEVICE

Commercially available device

A commercially available and registered with the FDA prosthesis equipped with a powered single-degree of freedom wrist and powered hand.

DEVICE

Non FDA registered device

An experimental, non FDA registered prosthesis equipped with a multi function wrist and a powered hand.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Levi Hargrove · Shirley Ryan AbilityLab

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2024-02-19
Completion
2024-02-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069793 on ClinicalTrials.gov