Functional Importance of a Powered Multifunction Wrist Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2024-02-19

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Home Trial Condition A

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

Group Type ACTIVE_COMPARATOR

Commercially available device

Intervention Type 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 B

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

Group Type EXPERIMENTAL

Non FDA registered device

Intervention Type DEVICE

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

Interventions

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Commercially available device

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

Intervention Type DEVICE

Non FDA registered device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No