NCT04069793

Functional Importance of a Powered Multifunction Wrist Protocol

Determining the Functional Importance of a Powered Multifunction Wrist

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this project is to evaluate the functional importance of a multi function wrist compared to a single degree of freedom wrist. This will be accomplished through in laboratory testing and an 8-week home trial. The first aim will involve in-laboratory functional performance testing with a 1-DOF or a 2-DOF wrist and a one degree of freedom hand. Changes in performance will be assessed with multiple outcome measures that include both quantitative and qualitative testing of prosthesis control and functional performance. The second aim will determine how a 2-DOF wrist impacts control and home use of a one degree of freedom hand. Subjects will compete an 8 week home based trial. Participants will be instructed to complete a written home log of activities and electronic logging usage data will also be collected for each experimental condition. The investigators hypothesize that adding a wrist flexion/extension module to a wrist rotation module and a single-DOF terminal device will provide significant improvements in function for transradial amputees.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-18
• Primary completion: 2024-02-19
• Completion: 2024-02-19
• First posted: 2019-08-28
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States