Clinical trial NCT04755790: To Assess the Utility of the Point Digit in a Clinical Take-home Study
Official title: To Assess the Utility of the Point Digit in a Clinical Take-home Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation; Traumatic, Hand
Lead sponsor: Point Designs
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Denver
name: Arm Dynamics
First posted: 2021-02-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
timeFrame: Day 0: no prosthesis (pre-fitting)
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: Day 0: no prosthesis (pre-fitting)
measure: Southampton Hand Assessment Procedure (SHAP)
timeFrame: Day 0: no prosthesis (pre-fitting)
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Day 0: no prosthesis (pre-fitting)
measure: Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
timeFrame: Day 0: with prosthesis, immediately post-fitting
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: Day 0: with prosthesis, immediately post-fitting
measure: Southampton Hand Assessment Procedure (SHAP)
timeFrame: Day 0: with prosthesis, immediately post-fitting
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Day 0: with prosthesis, immediately post-fitting
measure: Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
timeFrame: ~Day 30: with prosthesis, 30 days post-fitting
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: ~Day 30: with prosthesis, 30 days post-fitting
measure: Southampton Hand Assessment Procedure (SHAP)
timeFrame: ~Day 30: with prosthesis, 30 days post-fitting
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: ~Day 30: with prosthesis, 30 days post-fitting
measure: Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
timeFrame: ~Day 60: with prosthesis, 60 days post-fitting
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: ~Day 60: with prosthesis, 60 days post-fitting
measure: Southampton Hand Assessment Procedure (SHAP)
timeFrame: ~Day 60: with prosthesis, 60 days post-fitting
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: ~Day 60: with prosthesis, 60 days post-fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Point Designs
state: Colorado
city: Overland Park
country: United States
facility: Arm Dynamics
state: Kansas
city: Maple Grove
country: United States
facility: Arm Dynamics
state: Minnesota
city: Portland
country: United States
facility: Arm Dynamics
state: Oregon
city: Philadelphia
country: United States
facility: Arm Dynamics
state: Pennsylvania
city: Houston
country: United States
facility: Arm Dynamics
state: Texas
city: Irving
country: United States
facility: Arm Dynamics
state: Texas
Study officials:
References: