Upper Limb Amputation Below Elbow (Injury)SoftHandNCT02274532
Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study
A study testing SoftHand in people with Upper Limb Amputation Below Elbow (Injury), run by Karen L. Andrews, M.D..
Trial summary
A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Amputation Below Elbow (Injury)
- What is being tested?
- SoftHand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2014to 17 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Subjects > 18 years of age.
Who cannot join
- Patients with an amputation for less than 6 months.
- Patients who have been fit and trained to use a prothesis but chose not to do so.
- Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy and persistent weakness.
- 5) Visual problems that would interfere with our grasp task.
- 6) Co-existing central nervous system disease (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) that would interfere with our grasp task
- 7) Significant spasticity/rigidity as assessed through range of motion testing that would interfere with our grasp task.
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- 8) Active psychiatric illness.
- 9) Cognitive impairments which would interfere with following study instructions and filling out surveys (at the investigator's discretion).
- 10) Use of medications that might affect sensory and/or motor functions.
About this study
A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for activities of daily living (ADL).
Read the detailed description
Preliminary data suggest that the SoftHand Pro (SHpro) is extremely versatile and can be used to grasp and manipulate common objects. We will perform extensive testing of the myoelectric SHpro by asking subjects to perform a wide variety of ADL tasks in a structured environment onsite at Mayo Clinic Rochester. These data will be used by the Mayo Clinic, ASU, and the IIT research teams to modify the SHpro design to adapt it for use by people with amputations while focusing on the SHpro socket design, surface electromyography (EMG)-based control (typically used in commercially available prostheses today).
We will quantify the ability of patients with below-elbow amputation to perform the above tasks using the prosthetic terminal device version of the SHpro. We hypothesize that people with amputations will learn to use the SHpro and perform grasp and manipulation tasks to a greater level than that allowed by their current terminal devices.
The long-term objectives of this exploratory study are to design and build a low-cost, high-performance prosthetic hand terminal device that will be accepted by patients with below-elbow amputation and allow them to perform a wider range of ADL tasks than allowed by today's commercially available prostheses. The data collected through the proposed studies will provide an important foundation for optimizing the design of the SHpro for future testing on a large number of people with limb loss. Future studies will also assess the extent to which the SHpro's functionality and acceptance might benefit from embedding additional synergistic hand motion patterns in the SHpro.
- Being tested
- SoftHand
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftHandDevice
Also called SH, SHpro
Biomechanical, ADL, and functional testing.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Testing will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 5 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability, with the option with patients for a 1-week period of take-home testing and associated pre- and post-assessments. Receives: Device: SoftHand |
| Control | Other | Testing will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 4 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability. Control subjects will participate in two sessions, including a pre- and post-training assessments. Receives: Device: SoftHand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional assessments
DASH score, the Jebsen Taylor Test of Hand Function, and biomechanical measures (including total grip force, load force sharing between the thumb and finger(s), time to peak grip force, and net torque exerted by the subject at object lift onset).
Measured: 1 week
Secondary outcomes (1)
ADL tests
The AM-ULA ADL assessment will be used as secondary outcome measures to identify specific grasping tasks or task component(s) that a control or people with amputations subject might have difficulty performing.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start24 Oct 2014
- Primary completion17 May 2016
- Study completion17 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation Below Elbow (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen L. Andrews, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, University of Pisa
- Responsible party
- Sponsor-investigator, Karen L. Andrews, M.D., Mayo Clinic
- Investigators
- Karen L. Andrews, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274532
- Sponsor's protocol ID
- 13-008649
- Acronym
- SoftHand
- Status last verified
- Jan 2018
- First submitted
- 22 Oct 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02274532
- Acronym / sponsor ID
- SoftHand / 13-008649
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Karen L. Andrews, M.D.University, hospital or other
- Collaborators
- Arizona State University, University of Pisa
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for activities of daily living (ADL).
Detailed description
Preliminary data suggest that the SoftHand Pro (SHpro) is extremely versatile and can be used to grasp and manipulate common objects. We will perform extensive testing of the myoelectric SHpro by asking subjects to perform a wide variety of ADL tasks in a structured environment onsite at Mayo Clinic Rochester. These data will be used by the Mayo Clinic, ASU, and the IIT research teams to modify the SHpro design to adapt it for use by people with amputations while focusing on the SHpro socket design, surface electromyography (EMG)-based control (typically used in commercially available prostheses today).
We will quantify the ability of patients with below-elbow amputation to perform the above tasks using the prosthetic terminal device version of the SHpro. We hypothesize that people with amputations will learn to use the SHpro and perform grasp and manipulation tasks to a greater level than that allowed by their current terminal devices.
The long-term objectives of this exploratory study are to design and build a low-cost, high-performance prosthetic hand terminal device that will be accepted by patients with below-elbow amputation and allow them to perform a wider range of ADL tasks than allowed by today's commercially available prostheses. The data collected through the proposed studies will provide an important foundation for optimizing the design of the SHpro for future testing on a large number of people with limb loss. Future studies will also assess the extent to which the SHpro's functionality and acceptance might benefit from embedding additional synergistic hand motion patterns in the SHpro.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Device: SoftHandTesting will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 5 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability, with the option with patients for a 1-week period of take-home testing and associated pre- and post-assessments. |
| Control | Other | Device: SoftHandTesting will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 4 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability. Control subjects will participate in two sessions, including a pre- and post-training assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Subjects > 18 years of age.
Key exclusion criteria (9 listed)
- Patients with an amputation for less than 6 months.
- Patients who have been fit and trained to use a prothesis but chose not to do so.
- Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy and persistent weakness.
- 5) Visual problems that would interfere with our grasp task.
- 6) Co-existing central nervous system disease (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) that would interfere with our grasp task
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoftHandAlso: SH, SHproBiomechanical, ADL, and functional testing. | Device | Control, Patient |
Primary outcome
Functional assessments
Time frame: 1 week
DASH score, the Jebsen Taylor Test of Hand Function, and biomechanical measures (including total grip force, load force sharing between the thumb and finger(s), time to peak grip force, and net torque exerted by the subject at object lift onset).
1 secondary outcome
ADL tests
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L. Andrews, M.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing SoftHand in people with Upper Limb Amputation Below Elbow (Injury), run by Karen L. Andrews, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessments (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.