AmputationNCT07254247
A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss
A study testing Novel Prosthetic Hook in people with Amputation, run by Little Room Innovations, LLC at 1 site in United States.
Trial summary
We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices. The primary goal of this study is to validate the performance of the device against the commercial state-of-the-art in upper limb terminal devices. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Novel Prosthetic Hook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to 10 Apr 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are between the ages of 18-80 Are proficient in English Able to demonstrate proper functioning and safety of the terminal device
Who cannot join
- Have visual or mental impairments Have history of neurological or musculoskeletal disorders
Trial locations and contacts
1 site in 1 country.
About this study
We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices. The primary goal of this study is to validate the performance of the device against the commercial state-of-the-art in upper limb terminal devices.
- Conditions
- Amputation
- Being tested
- Novel Prosthetic Hook, Control Hook (Light Spring), Control Hook (Heavy Spring)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Prosthetic HookDevice
The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.
Control Hook (Light Spring)Device
The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring.
Control Hook (Heavy Spring)Device
The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring.
| Study group | Role | What they receive |
|---|---|---|
| Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) | Experimental | In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a light return spring, then the Control Hook with a heavy return spring. Receives: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring) |
| Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring) | Experimental | In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a heavy return spring, then the Control Hook with a light return spring. Receives: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring) |
| Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook | Experimental | In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Control Hook with a heavy return spring, and then the Novel Prosthetic Hook. Receives: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring) |
| Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook | Experimental | In this arm, participants will first complete the tests with the Control Hook with a heavy return spring, then the Control Hook with a light return spring, and then the Novel Prosthetic Hook. Receives: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring) |
| Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring) | Experimental | In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Novel Prosthetic Hook, and then the Control Hook with a heavy return spring, Receives: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring) |
| Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring) | Experimental | In this arm, participants will first complete the tests with the the Control Hook with a heavy return spring, then Novel Prosthetic Hook, and then the Control Hook with a light return spring. Receives: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified SHAP Average Completion Time
This is the average task completion time across all tasks performed in a modified version of the Southampton Hand Assessment Protocol (SHAP). The SHAP has been modified in this study to include only the relevant assessments to the prosthetic hooks being tested. A lower average score indicates better performance.
Measured: through study completion, an average of 1 day
Secondary outcomes (3)
Clothespin Relocation Task Average Time
This is a functional hand assessment that measures the time it takes to reposition clothespins of differing stiffnesses. Lower completion times indicate better performance.
Measured: through study completion, an average of 1 day
Borg Rating of Perceived Exertion (RPE)
This is a scale of 0 to 10 with 0 indicated by the participate as a measure of how difficult a task is.
Measured: through study completion, an average of 1 day
NASA Task Load Index
The NASA Task Load Index method assesses work load. The aggregate score reported scales from 0 to 100, where 100 indicates the maximum (hardest) workload.
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Little Room Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254247
- Sponsor's protocol ID
- R43HD115423
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss
- ClinicalTrials.gov ID
- NCT07254247
- Acronym / sponsor ID
- R43HD115423
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Little Room Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 28 Nov 2025 (actual)
- 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.
We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices. The primary goal of this study is to validate the performance of the device against the commercial state-of-the-art in upper limb terminal devices.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) | Experimental | Device: Novel Prosthetic Hook, Device: Control Hook (Light Spring), Device: Control Hook (Heavy Spring)In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a light return spring, then the Control Hook with a heavy return spring. |
| Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring) | Experimental | Device: Novel Prosthetic Hook, Device: Control Hook (Light Spring), Device: Control Hook (Heavy Spring)In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a heavy return spring, then the Control Hook with a light return spring. |
| Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook | Experimental | Device: Novel Prosthetic Hook, Device: Control Hook (Light Spring), Device: Control Hook (Heavy Spring)In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Control Hook with a heavy return spring, and then the Novel Prosthetic Hook. |
| Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook | Experimental | Device: Novel Prosthetic Hook, Device: Control Hook (Light Spring), Device: Control Hook (Heavy Spring)In this arm, participants will first complete the tests with the Control Hook with a heavy return spring, then the Control Hook with a light return spring, and then the Novel Prosthetic Hook. |
| Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring) | Experimental | Device: Novel Prosthetic Hook, Device: Control Hook (Light Spring), Device: Control Hook (Heavy Spring)In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Novel Prosthetic Hook, and then the Control Hook with a heavy return spring, |
| Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring) | Experimental | Device: Novel Prosthetic Hook, Device: Control Hook (Light Spring), Device: Control Hook (Heavy Spring)In this arm, participants will first complete the tests with the the Control Hook with a heavy return spring, then Novel Prosthetic Hook, and then the Control Hook with a light return spring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Are between the ages of 18-80 Are proficient in English Able to demonstrate proper functioning and safety of the terminal device
Key exclusion criteria (1 listed)
- Have visual or mental impairments Have history of neurological or musculoskeletal disorders
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 |
|---|---|---|
| Novel Prosthetic HookThe Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. | Device | Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook, Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring), Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook, Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring), Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring), Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) |
| Control Hook (Light Spring)The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. | Device | Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook, Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring), Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook, Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring), Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring), Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) |
| Control Hook (Heavy Spring)The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. | Device | Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook, Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring), Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook, Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring), Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring), Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) |
Primary outcome
Modified SHAP Average Completion Time
Time frame: through study completion, an average of 1 day
This is the average task completion time across all tasks performed in a modified version of the Southampton Hand Assessment Protocol (SHAP). The SHAP has been modified in this study to include only the relevant assessments to the prosthetic hooks being tested. A lower average score indicates better performance.
3 secondary outcomes
Clothespin Relocation Task Average Time
Time frame: through study completion, an average of 1 day
Borg Rating of Perceived Exertion (RPE)
Time frame: through study completion, an average of 1 day
NASA Task Load Index
Time frame: through study completion, an average of 1 day
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 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Prosthetic Hook in people with Amputation, run by Little Room Innovations, LLC at 1 site in United States.
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 1 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Modified SHAP Average Completion Time (time frame: through study completion, an average of 1 day). 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 31 Aug 2026.