SoftHand Comparison Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-28

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover design with first intervention randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Initial Assignment: SoftHand Pro

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

Group Type EXPERIMENTAL

SoftHand Pro

Intervention Type DEVICE

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

Ossur i-Limb

Intervention Type DEVICE

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

Initial Assignment: Ossur i-Limb

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

Group Type ACTIVE_COMPARATOR

SoftHand Pro

Intervention Type DEVICE

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

Ossur i-Limb

Intervention Type DEVICE

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

Interventions

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SoftHand Pro

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

Intervention Type DEVICE

Ossur i-Limb

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No