---
title: To Assess the Utility of the Point Digit in a Clinical Take-home Study
nct_id: NCT04755790
overall_status: COMPLETED
phase: NA
sponsor: Point Designs
study_type: INTERVENTIONAL
primary_condition: Amputation; Traumatic, Hand
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04755790.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04755790"
ct_last_update_post_date: 2024-01-24
last_seen_at: "2026-05-12T06:06:25.586Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# To Assess the Utility of the Point Digit in a Clinical Take-home Study

**NCT ID:** [NCT04755790](https://clinicaltrials.gov/study/NCT04755790)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 13
- **Lead Sponsor:** Point Designs
- **Collaborators:** University of Colorado, Denver, Arm Dynamics
- **Conditions:** Amputation; Traumatic, Hand
- **Start Date:** 2020-05-18
- **Completion Date:** 2022-12-31
- **CT.gov Last Update:** 2024-01-24

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **No Prosthesis** (NO_INTERVENTION) — Baseline outcome measurements will be performed without a prosthesis
- **Prosthesis** (EXPERIMENTAL) — Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting

## Interventions

- **Point Digit** (DEVICE) — Patient is fit with Point Digit partial hand prosthetic system

## Primary Outcomes

- **Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)** _(time frame: Day 0: no prosthesis (pre-fitting))_ — Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Disability of the Arm, Shoulder and Hand (DASH)** _(time frame: Day 0: no prosthesis (pre-fitting))_ — The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
- **Southampton Hand Assessment Procedure (SHAP)** _(time frame: Day 0: no prosthesis (pre-fitting))_ — The Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **EuroQol-5 Dimension (EQ-5D-5L)** _(time frame: Day 0: no prosthesis (pre-fitting))_ — Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)** _(time frame: Day 0: with prosthesis, immediately post-fitting)_ — Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Disability of the Arm, Shoulder and Hand (DASH)** _(time frame: Day 0: with prosthesis, immediately post-fitting)_ — The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
- **Southampton Hand Assessment Procedure (SHAP)** _(time frame: Day 0: with prosthesis, immediately post-fitting)_ — The Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **EuroQol-5 Dimension (EQ-5D-5L)** _(time frame: Day 0: with prosthesis, immediately post-fitting)_ — Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)** _(time frame: ~Day 30: with prosthesis, 30 days post-fitting)_ — Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Disability of the Arm, Shoulder and Hand (DASH)** _(time frame: ~Day 30: with prosthesis, 30 days post-fitting)_ — The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
- **Southampton Hand Assessment Procedure (SHAP)** _(time frame: ~Day 30: with prosthesis, 30 days post-fitting)_ — The Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **EuroQol-5 Dimension (EQ-5D-5L)** _(time frame: ~Day 30: with prosthesis, 30 days post-fitting)_ — Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)** _(time frame: ~Day 60: with prosthesis, 60 days post-fitting)_ — Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **Disability of the Arm, Shoulder and Hand (DASH)** _(time frame: ~Day 60: with prosthesis, 60 days post-fitting)_ — The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
- **Southampton Hand Assessment Procedure (SHAP)** _(time frame: ~Day 60: with prosthesis, 60 days post-fitting)_ — The Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
- **EuroQol-5 Dimension (EQ-5D-5L)** _(time frame: ~Day 60: with prosthesis, 60 days post-fitting)_ — Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

## Locations (7)

- Point Designs, Lafayette, Colorado, United States
- Arm Dynamics, Overland Park, Kansas, United States
- Arm Dynamics, Maple Grove, Minnesota, United States
- Arm Dynamics, Portland, Oregon, United States
- Arm Dynamics, Philadelphia, Pennsylvania, United States
- Arm Dynamics, Houston, Texas, United States
- Arm Dynamics, Irving, Texas, United States

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.point designs|lafayette|colorado|united states` — added _(2026-05-12)_
- `locations.arm dynamics|overland park|kansas|united states` — added _(2026-05-12)_
- `locations.arm dynamics|maple grove|minnesota|united states` — added _(2026-05-12)_
- `locations.arm dynamics|portland|oregon|united states` — added _(2026-05-12)_
- `locations.arm dynamics|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.arm dynamics|houston|texas|united states` — added _(2026-05-12)_
- `locations.arm dynamics|irving|texas|united states` — added _(2026-05-12)_

---

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