SoftHand Comparison Study

NCT05328934 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 21-005070
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 Weeks

Secondary Outcomes (9)

• Upper Extremity Functional Ability [2]

  8 Weeks

• Upper Extremity Manual Dexterity

  8 Weeks

• Hand Motor Function

  8 Weeks

• Occupational Performance

  8 Weeks

• Quality of Life

  8 Weeks

Other Outcomes (1)

• Prosthesis User Preference

  8 Weeks

Study Arms (2)

Initial Assignment: SoftHand Pro

EXPERIMENTAL

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

Device: SoftHand Pro; Device: Ossur i-Limb

Initial Assignment: Ossur i-Limb

ACTIVE COMPARATOR

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

Device: SoftHand Pro; Device: Ossur i-Limb

Interventions

SoftHand Pro DEVICE

Performance assessments utilizing the SoftHand Pro over an 8-week period.

Initial Assignment: Ossur i-Limb; Initial Assignment: SoftHand Pro

Ossur i-Limb DEVICE

Performance assessments utilizing the i-Limb over an 8-week period.

Initial Assignment: Ossur i-Limb; Initial Assignment: SoftHand Pro

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 proficient owner of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic.

You may not qualify if:

• 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;
• symptomatic brachial plexopathy, cervical radiculopathy or polyneuropathy (observed);
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Arizona State University: collaborator
• Hanger Clinic: Prosthetics & Orthotics: collaborator

Study Sites (2)

Arizona State University

Tempe, Arizona, 85281-9709, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Arm Injuries; Upper Extremity Deformities, Congenital; Amputation, Traumatic; Amputation, Congenital

Condition Hierarchy (Ancestors)

Wounds and Injuries; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marco Santello, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Kristin D. Zhao, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover design with first intervention randomized.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: April 28, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)