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SoftHand Comparison Study

Primary Purpose

Upper Extremity Injury, Upper Extremity Deformities, Congenital, Amputation, Traumatic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SoftHand Pro
Ossur i-Limb
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Extremity Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis);
  2. the individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable;
  3. the individual is a user of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic.

Exclusion Criteria:

  1. individuals who have had transradial amputation for less than 6 months;
  2. individuals who have been fit and trained to use a prosthesis but chose not to use one;
  3. individuals who use the i-Limb Quantum myoelectric prosthesis;
  4. clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy;
  5. orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed);
  6. visual problems that would interfere with the grasping;
  7. co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history;
  8. limited range of motion as assessed through range of motion testing;
  9. inability to follow study instructions;
  10. use of medications that might affect sensory and/or motor functions.

Sites / Locations

  • Marco Santello
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial Assignment: SoftHand Pro

Initial Assignment: Ossur i-Limb

Arm Description

This arm of the crossover design will begin the trial using the SoftHand Pro.

This arm of the crossover design will begin the trial using the i-Limb.

Outcomes

Primary Outcome Measures

Upper Extremity Functional Ability [1]
Change in upper extremity function, as measured by the Activities Measure for Upper Limb Amputees (AM-ULA). Participants complete 17 tasks, rated on task completion, speed of completion, movement quality, skillfulness of prosthesis use, and independence from the use of other assistive devices or adaptive environments with the prosthesis. The scale is 0 to 4, with a higher number representing higher performance in each category. Scores in each category are averaged for a Grade in each task. Grades for the 17 tasks are averaged and multiplied by 40 for a final score of 0 - 40, with a higher number representing higher overall function.

Secondary Outcome Measures

Upper Extremity Functional Ability [2]
Change in upper extremity function, as measured by the Action Research Arm Test (ARAT). Participants perform up to 19 tasks categorized by grasp, grip, pinch, and gross movement. The scale is 0 to 3, with a higher number representing higher performance in each category. Categories are scored separately.
Upper Extremity Manual Dexterity
Change in upper extremity gross manual dexterity, as measured by the Box and Blocks test. Participants are tested in a timed transfer of blocks from one side of a box to another side over a low partition. A higher number of blocks successfully transferred during the timed episode represents a higher level of upper extremity manual dexterity.
Hand Motor Function
Change in fine and gross motor hand function, as measured by the Jebsen-Taylor Hand Function Test. Participants are timed in seven activities of daily living closely involving use of the hand, with a lower number of seconds required to complete the task representing a higher level of motor hand function.
Occupational Performance
Change in participants' perceived occupational performance, as measured by the Canadian Occupational Performance Measure (COPM). Participants choose up to 5 occupational performance problems; their perception of their own performance and their satisfaction with their performance regarding each problem is measured on a 1 to 10 scale, with higher scores representing higher performance and satisfaction. The difference in performance and satisfaction is calculated, and then the differences for all problems together are totaled and averaged, with the average divided by the number of problems establishing the final score for each performance and satisfaction. Higher averages represent better perceived performance and satisfaction.
Quality of Life
Change in participants' perceived quality of life, as measured by the the World Health Organization Quality of Life Disabilities Module (WHOQOL-DIS). Participants answer qualitative questions regarding patient activities, independence, and overall quality of life on a 1 to 5 scale, with a higher number indicating a higher concurrence or frequency related to the item in question, and totaled for a score which categorizes patient quality of life.
Upper Extremity Function and Pain
Change in participants' perceived levels of upper extremity physical function and symptoms, as measured by the Disabilities of the Arm, Shoulder, and Hand Score (QuickDASH). Participants rate their difficulty with examples of physical function and their severity of physical symptoms on a 1 to 5 scale, with higher values representing more severe difficulties and symptoms. The scores are combined in a calculation which results in an overall score, with higher scores representing more severe overall difficulties and symptoms.
Overall Functional Performance
Change in participants' perceived functional performance, as measured by the Patient-Specific Functional Scale. Participants select 5 or more activities for which they perceive a problem, rating their own performance of that activity on a scale of 0 to 10, with higher values representing greater ability to perform the activity. The scores are totaled and divided by the number of tasks for an average score, with higher values representing better performance.
Prosthesis Overall Functional Utility
Change in participants' perception of the utility of their currently-used prosthesis, as measured by the Orthotics Prosthetics Users Survey - Upper Extremity Functional Status (OPUS). Participants rate the prosthetic's ease of use for a variety of daily activities, 23 of which are scored, on a 0 to 4 scale, with higher values representing easier use. Scores are totaled and converted to a 0 to 92 scale, with higher overall scores representing better functional utility with the prosthesis.

Full Information

First Posted
April 7, 2022
Last Updated
May 15, 2023
Sponsor
Mayo Clinic
Collaborators
Arizona State University, Hanger Clinic: Prosthetics & Orthotics
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1. Study Identification

Unique Protocol Identification Number
NCT05328934
Brief Title
SoftHand Comparison Study
Official Title
Toward Use of the Synergy-based SoftHand Pro for Activities of Daily Living by Persons With Transradial Limb Loss: A Multi-site Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Arizona State University, Hanger Clinic: Prosthetics & Orthotics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.
Detailed Description
This study will measure improvements in outcomes obtained from laboratory testing of the SHP and i-Limb from baseline to after 8 weeks of daily use. A secondary analysis will incorporate the subjects' existing prosthetic hands. Finally, surveys and usage data collected through the SHP and i-Limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Injury, Upper Extremity Deformities, Congenital, Amputation, Traumatic, Amputation, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover design with first intervention randomized.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Initial Assignment: SoftHand Pro
Arm Type
Experimental
Arm Description
This arm of the crossover design will begin the trial using the SoftHand Pro.
Arm Title
Initial Assignment: Ossur i-Limb
Arm Type
Active Comparator
Arm Description
This arm of the crossover design will begin the trial using the i-Limb.
Intervention Type
Device
Intervention Name(s)
SoftHand Pro
Intervention Description
Performance assessments utilizing the SoftHand Pro over an 8-week period.
Intervention Type
Device
Intervention Name(s)
Ossur i-Limb
Intervention Description
Performance assessments utilizing the i-Limb over an 8-week period.
Primary Outcome Measure Information:
Title
Upper Extremity Functional Ability [1]
Description
Change in upper extremity function, as measured by the Activities Measure for Upper Limb Amputees (AM-ULA). Participants complete 17 tasks, rated on task completion, speed of completion, movement quality, skillfulness of prosthesis use, and independence from the use of other assistive devices or adaptive environments with the prosthesis. The scale is 0 to 4, with a higher number representing higher performance in each category. Scores in each category are averaged for a Grade in each task. Grades for the 17 tasks are averaged and multiplied by 40 for a final score of 0 - 40, with a higher number representing higher overall function.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Upper Extremity Functional Ability [2]
Description
Change in upper extremity function, as measured by the Action Research Arm Test (ARAT). Participants perform up to 19 tasks categorized by grasp, grip, pinch, and gross movement. The scale is 0 to 3, with a higher number representing higher performance in each category. Categories are scored separately.
Time Frame
8 Weeks
Title
Upper Extremity Manual Dexterity
Description
Change in upper extremity gross manual dexterity, as measured by the Box and Blocks test. Participants are tested in a timed transfer of blocks from one side of a box to another side over a low partition. A higher number of blocks successfully transferred during the timed episode represents a higher level of upper extremity manual dexterity.
Time Frame
8 Weeks
Title
Hand Motor Function
Description
Change in fine and gross motor hand function, as measured by the Jebsen-Taylor Hand Function Test. Participants are timed in seven activities of daily living closely involving use of the hand, with a lower number of seconds required to complete the task representing a higher level of motor hand function.
Time Frame
8 Weeks
Title
Occupational Performance
Description
Change in participants' perceived occupational performance, as measured by the Canadian Occupational Performance Measure (COPM). Participants choose up to 5 occupational performance problems; their perception of their own performance and their satisfaction with their performance regarding each problem is measured on a 1 to 10 scale, with higher scores representing higher performance and satisfaction. The difference in performance and satisfaction is calculated, and then the differences for all problems together are totaled and averaged, with the average divided by the number of problems establishing the final score for each performance and satisfaction. Higher averages represent better perceived performance and satisfaction.
Time Frame
8 Weeks
Title
Quality of Life
Description
Change in participants' perceived quality of life, as measured by the the World Health Organization Quality of Life Disabilities Module (WHOQOL-DIS). Participants answer qualitative questions regarding patient activities, independence, and overall quality of life on a 1 to 5 scale, with a higher number indicating a higher concurrence or frequency related to the item in question, and totaled for a score which categorizes patient quality of life.
Time Frame
8 Weeks
Title
Upper Extremity Function and Pain
Description
Change in participants' perceived levels of upper extremity physical function and symptoms, as measured by the Disabilities of the Arm, Shoulder, and Hand Score (QuickDASH). Participants rate their difficulty with examples of physical function and their severity of physical symptoms on a 1 to 5 scale, with higher values representing more severe difficulties and symptoms. The scores are combined in a calculation which results in an overall score, with higher scores representing more severe overall difficulties and symptoms.
Time Frame
8 Weeks
Title
Overall Functional Performance
Description
Change in participants' perceived functional performance, as measured by the Patient-Specific Functional Scale. Participants select 5 or more activities for which they perceive a problem, rating their own performance of that activity on a scale of 0 to 10, with higher values representing greater ability to perform the activity. The scores are totaled and divided by the number of tasks for an average score, with higher values representing better performance.
Time Frame
8 Weeks
Title
Prosthesis Overall Functional Utility
Description
Change in participants' perception of the utility of their currently-used prosthesis, as measured by the Orthotics Prosthetics Users Survey - Upper Extremity Functional Status (OPUS). Participants rate the prosthetic's ease of use for a variety of daily activities, 23 of which are scored, on a 0 to 4 scale, with higher values representing easier use. Scores are totaled and converted to a 0 to 92 scale, with higher overall scores representing better functional utility with the prosthesis.
Time Frame
8 Weeks
Other Pre-specified Outcome Measures:
Title
Prosthesis User Preference
Description
Changes in participants' perception of the utility, functional performance, ergonomics, and ease of use of their currently-used prosthesis, as measured by a custom Active Use questionnaire. Participants rate the extent to which they agree to 12 to 14 statements (depending of which prosthesis) on a 1 to 10 scale, with higher ratings representing closer agreement. Individual statements are assessed separately (no overall score).
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis); the individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable; the individual is a user of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic. Exclusion Criteria: individuals who have had transradial amputation for less than 6 months; individuals who have been fit and trained to use a prosthesis but chose not to use one; individuals who use the i-Limb Quantum myoelectric prosthesis; clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy; orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed); visual problems that would interfere with the grasping; co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history; limited range of motion as assessed through range of motion testing; inability to follow study instructions; use of medications that might affect sensory and/or motor functions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Santello, Ph.D.
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marco Santello
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281-9709
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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SoftHand Comparison Study

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