Functional Importance of a Powered Multifunction Wrist Protocol

NCT04069793 | Completed

• 2 other identifiers: STU002065315R01HD094861-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transradial Amputee

Outcome Measures

Primary Outcomes (1)

• Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance

  Measuring the function of upper limb prostheses is challenging and requires multiple test formats. A toolkit of functional outcome tests recommend by the Academy of Prosthetics and Orthotics ULPOM committee will be used to measure functional effectiveness of prosthetic treatment will be used as the primary outcome measure. The outcome measures to evaluate prosthesis use includes both quantitative and qualitative testing of prosthesis control and functional performance.

  Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B

Secondary Outcomes (8)

• SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.

  Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B

• Modified Box and Blocks Test of Manual Dexterity

  Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B

• Jebsen-Taylor Hand Function Test

  Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B

• Assessment of Capacity for Myoelectric Control (ACMC)

  Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B

• Orthotics and Prosthetics User Survey - Upper Extremity Function Status

  Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B

Study Arms (2)

Home Trial Condition A

ACTIVE COMPARATOR

Subject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand.

Device: Commercially available device

Home Trial Condition B

EXPERIMENTAL

Subject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand.

Device: Non FDA registered device

Interventions

Commercially available device DEVICE

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

Home Trial Condition A

Non FDA registered device DEVICE

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

Home Trial Condition B

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-95
• A unilateral upper limb amputation or absence below the elbow
• English speaking

You may not qualify if:

• Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
• Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
• Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Study Officials

• Levi Hargrove

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Bionic Medicine

Model Details: Study Design includes using the subjects to complete both aims in a balanced randomized cross-over study. Using blocked randomization, which will be achieve using a simple randomization script written in Matlab. The two study conditions that will be analyzed are: Condition A-a single DOF terminal device with a 1-DOF (rotation) wrist Condition B-a single DOF terminal device with a 2-DOF (rotation + flexion/extension) wrist Condition A is the control condition in this project as it represents the state-of-the-art in clinical care. Condition B is the experimental arm.

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 28, 2019
• Study Start: January 18, 2018
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)