NCT05038566

Dexterous Partial Hand Prosthesis Outcomes

Completed NA Results posted Last updated 17 January 2025

What this trial tests

NA trial testing Pointdexter in Amputation in 4 participants. Completed in 28 April 2022.

Timeline

15 July 2021

Primary endpoint
28 April 2022

28 April 2022

Quick facts

Lead sponsor	Liberating Technologies, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	device feasibility
Enrollment	4
Start date	15 July 2021
Primary completion	28 April 2022
Estimated completion	28 April 2022
Sites	2 locations across United States

Drugs / interventions tested

• Pointdexter

Conditions studied

• Amputation — all drugs for Amputation →
• Amputation; Traumatic, Hand — all drugs for Amputation; Traumatic, Hand →
• Limb; Absence, Congenital, Upper — all drugs for Limb; Absence, Congenital, Upper →
• Prosthesis User — all drugs for Prosthesis User →

Sponsor

Liberating Technologies, Inc.

Who can join

Eligibility, any sex, with Amputation or Amputation; Traumatic, Hand. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Jebsen-Taylor Small Common Objects Functional Test Primary · 4 hours at a single site visit

During the in-lab portion of the study, subjects will be asked to complete the 'small common objects' subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. The maximum time allotted for each task was 120 seconds, at which point the subject was told to stop the task and the time was reported as the maximum 120 seconds. This test will be used to evaluate the feasibility of the device design as compared with a baseline condition

Turning a Card Over

Group	Value	95% CI
Comparator Baseline	34.8	± 20.5
Pointdexter	26.1	± 4.5

Small Common Objects

Group	Value	95% CI
Comparator Baseline	97.2	± 32.2
Pointdexter	62.1	± 2.2

Stacking Checkers

Group	Value	95% CI
Comparator Baseline	37.5	± 43.1
Pointdexter	28	± 21.8

Manipulating Cloth

Group	Value	95% CI
Comparator Baseline	5.4	± 1.5
Pointdexter	5.8	± 1.7

Holding a Screw

Group	Value	95% CI
Comparator Baseline	24.1	± 1.8
Pointdexter	65.7	± 34.7

9-Hole Out

Group	Value	95% CI
Comparator Baseline	11.4	± 8.1
Pointdexter	23.3	± 19

9-Hole In

Group	Value	95% CI
Comparator Baseline	120	± 0
Pointdexter	63.8	± 57.3

Removing Pen Cap

Group	Value	95% CI
Comparator Baseline	5.8	± 2.3
Pointdexter	7.1	± 4.2

Sponsor's own description

Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participants' existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.