CompletedNot Applicable

To Assess the Utility of the Point Digit in a Clinical Take-home Study

United States13 participantsStarted 2020-05-18

Plain-language summary

This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met. * Fluent in English * Individuals aged 18 or greater Exclusion Criteria: * Significant cognitive deficits as determined upon clinical evaluation * Significant neurological deficits as determined upon clinical evaluation * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation * Serious uncontrolled medical problems as judged by the project therapist.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)

Timeframe: Day 0: no prosthesis (pre-fitting)

Disability of the Arm, Shoulder and Hand (DASH)

Timeframe: Day 0: no prosthesis (pre-fitting)

Southampton Hand Assessment Procedure (SHAP)

Timeframe: Day 0: no prosthesis (pre-fitting)

EuroQol-5 Dimension (EQ-5D-5L)

Timeframe: Day 0: no prosthesis (pre-fitting)

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)

Timeframe: Day 0: with prosthesis, immediately post-fitting

Disability of the Arm, Shoulder and Hand (DASH)

Timeframe: Day 0: with prosthesis, immediately post-fitting

Southampton Hand Assessment Procedure (SHAP)

Timeframe: Day 0: with prosthesis, immediately post-fitting

Trial details

NCT IDNCT04755790

SponsorPoint Designs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2023-10-28

View on ClinicalTrials.gov More Amputation; Traumatic, Hand trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)

Timeframe: Day 0: no prosthesis (pre-fitting)

Disability of the Arm, Shoulder and Hand (DASH)

Timeframe: Day 0: no prosthesis (pre-fitting)

Southampton Hand Assessment Procedure (SHAP)

Timeframe: Day 0: no prosthesis (pre-fitting)

EuroQol-5 Dimension (EQ-5D-5L)

Timeframe: Day 0: no prosthesis (pre-fitting)

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)

Timeframe: Day 0: with prosthesis, immediately post-fitting

Disability of the Arm, Shoulder and Hand (DASH)

Timeframe: Day 0: with prosthesis, immediately post-fitting

Southampton Hand Assessment Procedure (SHAP)

Timeframe: Day 0: with prosthesis, immediately post-fitting