SoftHand Comparison Study

Mayo Clinic

Status: Active, not recruiting

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

Treatments: Device: SoftHand Pro; Device: Ossur i-Limb

Study type: Interventional

Funder types: Other

Identifiers

NCT05328934

21-005070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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 proficient owner 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. symptomatic brachial plexopathy, cervical radiculopathy or polyneuropathy (observed);
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Initial Assignment: SoftHand Pro

Experimental group

Description:

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

Treatment:

Device: Ossur i-Limb

Device: SoftHand Pro

Initial Assignment: Ossur i-Limb

Active Comparator group

Description:

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

Treatment:

Device: Ossur i-Limb

Device: SoftHand Pro