Clinical trial NCT05328934: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Upper Extremity Injury
Upper Extremity Deformities, Congenital
Amputation, Traumatic
Amputation, Congenital
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Hanger Clinic: Prosthetics & Orthotics
First posted: 2022-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover design with first intervention randomized.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper Extremity Functional Ability [1]
timeFrame: 8 Weeks
Secondary outcomes:
measure: Upper Extremity Functional Ability [2]
timeFrame: 8 Weeks
measure: Upper Extremity Manual Dexterity
timeFrame: 8 Weeks
measure: Hand Motor Function
timeFrame: 8 Weeks
measure: Occupational Performance
timeFrame: 8 Weeks
measure: Quality of Life
timeFrame: 8 Weeks
measure: Upper Extremity Function and Pain
timeFrame: 8 Weeks
measure: Overall Functional Performance
timeFrame: 8 Weeks
measure: Prosthesis Overall Functional Utility
timeFrame: 8 Weeks
measure: Arm Pain
timeFrame: 8 Weeks
Other outcomes:
measure: Prosthesis User Preference
timeFrame: 8 Weeks
Locations:
city: Tempe
country: United States
facility: Marco Santello
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Arizona State University
name: Marco Santello, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Kristin D. Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: