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Functional Importance of a Powered Multifunction Wrist Protocol

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Commercially available device
Non FDA registered device
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Upper Limb Amputation at the Hand focused on measuring Transradial Amputee

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Home Trial Condition A

Home Trial Condition B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.
An objective test of unilateral hand function that can be used to evaluate functionality of passive, mechanical, or myoelectric hands without bias to type [31]. Movement of abstract objects (classified into six prehension patterns) and activities of daily living are timed by the subject. Scores are compared to a normalized, able-bodied control score of 100.
Modified Box and Blocks Test of Manual Dexterity
A timed test that evaluates gross manual dexterity. Small (1-inch) blocks are moved one at a time from one side of a box to the other over a wooden partition. The final score is the number of blocks transferred in 1 minute, typically averaged over three trials. For this test, only opening and closing of the terminal device is required, although subjects with transradial amputations do typically use compensatory movements. It is possible that a 2-DOF wrist may move inadvertently and impair performance on this task. As a result, we would view either an improvement or no change in this score to be a positive finding.
Jebsen-Taylor Hand Function Test
A standardized test of manual dexterity that evaluates hand function during performance of seven hand-related tasks using common items such as cards, cans, paper clips, and coins [32]. Subjects are evaluated by the time required to complete each task
Assessment of Capacity for Myoelectric Control (ACMC)
An observational assessment tool that measures the subject's ability to control a myoelectric hand. The ability to control gripping, holding, releasing, and coordinating 30 items is scored on a 4-point capability scale. The prosthetic hand is used in an active assist or passive support role. Rasch analysis is used to convert capability ratings to a single measure of each subject's functional ability. Both Ms Turner and Dr. Miller are trained to complete this assessment.
Orthotics and Prosthetics User Survey - Upper Extremity Function Status
A 19- item, self-reported measure of an individual's ability to perform self-care and upper limb-based daily living tasks (e.g. button shirt, tie shoelaces) using a 5-point scale [35]. Rasch analysis of the questionnaire ratings is used to calculate an overall measure of each subject's functional ability.
Patient Specific Functional Scale
A questionnaire that asks patients to list up to five tasks they have difficulty with and rate the difficulty on an 11-point numerical scale [36]. Difficulty ratings can be averaged for each participant.
Clothespin Relocation Test
A test of prosthetic function that requires the user to move three clothespins from a vertical bar to a horizontal bar (thereby requiring use of the elbow, terminal device, and wrist rotator). This test has been in use by CBM as a measure of prosthesis function for over a decade.
Virtual Testing: Target Achievement Control Test
For the TAC Test, participants must move the virtual hand into a target posture and hold it there for a preset period of time. The TAC Test can require movement of from one to all available degrees of freedom (e.g. hand grasp plus wrist motion). Results are measured in terms of classification accuracy, completion rate, completion time, and path efficiency. This test will be used to ensure that subjects have satisfactory PR control over all DOFs prior to starting their home trial.

Full Information

First Posted
August 9, 2019
Last Updated
June 13, 2023
Sponsor
Shirley Ryan AbilityLab
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04069793
Brief Title
Functional Importance of a Powered Multifunction Wrist Protocol
Official Title
Determining the Functional Importance of a Powered Multifunction Wrist
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Amputation at the Hand, Upper Limb Amputation at the Wrist, Amputation, Amputation; Traumatic, Limb
Keywords
Transradial Amputee

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Trial Condition A
Arm Type
Active Comparator
Arm Description
Subject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand.
Arm Title
Home Trial Condition B
Arm Type
Experimental
Arm Description
Subject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand.
Intervention Type
Device
Intervention Name(s)
Commercially available device
Intervention Description
A commercially available and registered with the FDA prosthesis equipped with a powered single-degree of freedom wrist and powered hand.
Intervention Type
Device
Intervention Name(s)
Non FDA registered device
Intervention Description
An experimental, non FDA registered prosthesis equipped with a multi function wrist and a powered hand.
Primary Outcome Measure Information:
Title
Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
Description
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.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Secondary Outcome Measure Information:
Title
SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.
Description
An objective test of unilateral hand function that can be used to evaluate functionality of passive, mechanical, or myoelectric hands without bias to type [31]. Movement of abstract objects (classified into six prehension patterns) and activities of daily living are timed by the subject. Scores are compared to a normalized, able-bodied control score of 100.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Modified Box and Blocks Test of Manual Dexterity
Description
A timed test that evaluates gross manual dexterity. Small (1-inch) blocks are moved one at a time from one side of a box to the other over a wooden partition. The final score is the number of blocks transferred in 1 minute, typically averaged over three trials. For this test, only opening and closing of the terminal device is required, although subjects with transradial amputations do typically use compensatory movements. It is possible that a 2-DOF wrist may move inadvertently and impair performance on this task. As a result, we would view either an improvement or no change in this score to be a positive finding.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Jebsen-Taylor Hand Function Test
Description
A standardized test of manual dexterity that evaluates hand function during performance of seven hand-related tasks using common items such as cards, cans, paper clips, and coins [32]. Subjects are evaluated by the time required to complete each task
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Assessment of Capacity for Myoelectric Control (ACMC)
Description
An observational assessment tool that measures the subject's ability to control a myoelectric hand. The ability to control gripping, holding, releasing, and coordinating 30 items is scored on a 4-point capability scale. The prosthetic hand is used in an active assist or passive support role. Rasch analysis is used to convert capability ratings to a single measure of each subject's functional ability. Both Ms Turner and Dr. Miller are trained to complete this assessment.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Orthotics and Prosthetics User Survey - Upper Extremity Function Status
Description
A 19- item, self-reported measure of an individual's ability to perform self-care and upper limb-based daily living tasks (e.g. button shirt, tie shoelaces) using a 5-point scale [35]. Rasch analysis of the questionnaire ratings is used to calculate an overall measure of each subject's functional ability.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Patient Specific Functional Scale
Description
A questionnaire that asks patients to list up to five tasks they have difficulty with and rate the difficulty on an 11-point numerical scale [36]. Difficulty ratings can be averaged for each participant.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Clothespin Relocation Test
Description
A test of prosthetic function that requires the user to move three clothespins from a vertical bar to a horizontal bar (thereby requiring use of the elbow, terminal device, and wrist rotator). This test has been in use by CBM as a measure of prosthesis function for over a decade.
Time Frame
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Title
Virtual Testing: Target Achievement Control Test
Description
For the TAC Test, participants must move the virtual hand into a target posture and hold it there for a preset period of time. The TAC Test can require movement of from one to all available degrees of freedom (e.g. hand grasp plus wrist motion). Results are measured in terms of classification accuracy, completion rate, completion time, and path efficiency. This test will be used to ensure that subjects have satisfactory PR control over all DOFs prior to starting their home trial.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levi Hargrove
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Functional Importance of a Powered Multifunction Wrist Protocol

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