Evaluating the Point Powered partial hand prosthetic system
This study is testing a new device called the Point Powered partial hand prosthetic system. It's designed for people who have lost part of their hand due to amputation, specifically at least their index and/or middle fingers at the MCP (knuckle) level, while still having a fully functional thumb. The study aims to see how well this new system works compared to your current prosthetic treatment. Researchers will measure things like how well you can use your hand, your personal experience, and how much you wear the prosthesis. To join, you need to be at least 18 years old, speak English fluently, and have a healed residual limb. The study is looking for 10 participants.
- Study design
- This study will involve 10 adult participants with partial hand amputations. It uses a crossover design, meaning you will try both your current prosthetic and the Point Powered system.
- What's involved
- You will be evaluated on your existing prosthetic treatment and the Point Powered system over a period of three months. This will include in-clinic functional measures, subjective assessments, and tracking of bilateral hand use and prosthesis wear time.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, such as the Assessment of Capacity for Myoelectric Control (ACMC) and The Southampton Hand Assessment Procedure (SHAP), are measured at Baseline (pre-fitting).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
To Evaluate the Clinical Impact of the Point Powered System
At a glance
Conditions
NCT07135947
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hanger Clinic
Lafayette, Coloradostudy coordinator listed
Point Designs
Broomfield, Coloradostudy coordinator listed
University of Colorado Denver | Anschutz Medical Campus
Aurora, Coloradostudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Levin Sliker, PhD · PRINCIPAL_INVESTIGATOR · Point Designs
Who to contact
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Inclusion
Exclusion
What this trial measures
- Assessment of Capacity for Myoelectric Control (ACMC)Baseline (pre-fitting)
The proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. ACMC is the only measure that has been validated for individuals with upper limb (UL) loss who use myoelectric control and has been shown to demonstrate good test-retest reliability.
- The Southampton Hand Assessment Procedure (SHAP)Baseline (pre-fitting)
The SHAP is a time based test of a standardized protocol of 26 timed activities of daily living (ADL) tasks. The SHAP has a set of "common objects" representative of everyday items for the user to pick up. The results of the SHAP is a score which directly compares the abilities of the subject with those of intact able-bodied individuals as well as more refined scores for six prehensile patterns. A SHAP score of 100 is what an intact person is expected to achieve. This test has been validated for normative data.
- PROMIS Social IsolationBaseline (pre-fitting)
PROMIS Social Isolation is a self-reported person-centered measure that focuses on perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Ability to ParticipateBaseline (pre-fitting)
PROMIS Ability to Participate is a self-reported person-centered measure that focuses on perceived ability to perform one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Physical Function - Upper ExtremityBaseline (pre-fitting)
PROMIS Physical Function - Upper Extremity is a self-reported person-centered measure that focuses on capability to perform activities that require use of the upper extremity including shoulder, arm, and hand. Examples include writing, using buttons, or opening containers. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Satisfaction with Social Roles and ActivitiesBaseline (pre-fitting)
PROMIS Satisfaction with Social Roles and Activities is a self-reported person-centered measure that focuses on satisfaction with performing one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- Assessment of Capacity for Myoelectric Control (ACMC)Immediately post-fitting
The proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. ACMC is the only measure that has been validated for individuals with upper limb (UL) loss who use myoelectric control and has been shown to demonstrate good test-retest reliability.
- The Southampton Hand Assessment Procedure (SHAP)Immediately post-fitting
The SHAP is a time based test of a standardized protocol of 26 timed activities of daily living (ADL) tasks. The SHAP has a set of "common objects" representative of everyday items for the user to pick up. The results of the SHAP is a score which directly compares the abilities of the subject with those of intact able-bodied individuals as well as more refined scores for six prehensile patterns. A SHAP score of 100 is what an intact person is expected to achieve. This test has been validated for normative data.
- PROMIS Social IsolationImmediately post-fitting
PROMIS Social Isolation is a self-reported person-centered measure that focuses on perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Ability to ParticipateImmediately post-fitting
PROMIS Ability to Participate is a self-reported person-centered measure that focuses on perceived ability to perform one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Physical Function - Upper ExtremityImmediately post-fitting
PROMIS Physical Function - Upper Extremity is a self-reported person-centered measure that focuses on capability to perform activities that require use of the upper extremity including shoulder, arm, and hand. Examples include writing, using buttons, or opening containers. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Satisfaction with Social Roles and ActivitiesImmediately post-fitting
PROMIS Satisfaction with Social Roles and Activities is a self-reported person-centered measure that focuses on satisfaction with performing one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- Assessment of Capacity for Myoelectric Control (ACMC)30 days post-fitting
The proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. ACMC is the only measure that has been validated for individuals with upper limb (UL) loss who use myoelectric control and has been shown to demonstrate good test-retest reliability.
- The Southampton Hand Assessment Procedure (SHAP)30 days post-fitting
The SHAP is a time based test of a standardized protocol of 26 timed activities of daily living (ADL) tasks. The SHAP has a set of "common objects" representative of everyday items for the user to pick up. The results of the SHAP is a score which directly compares the abilities of the subject with those of intact able-bodied individuals as well as more refined scores for six prehensile patterns. A SHAP score of 100 is what an intact person is expected to achieve. This test has been validated for normative data.
- PROMIS Social Isolation30 days post-fitting
PROMIS Social Isolation is a self-reported person-centered measure that focuses on perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Ability to Participate30 days post-fitting
PROMIS Ability to Participate is a self-reported person-centered measure that focuses on perceived ability to perform one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Physical Function - Upper Extremity30 days post-fitting
PROMIS Physical Function - Upper Extremity is a self-reported person-centered measure that focuses on capability to perform activities that require use of the upper extremity including shoulder, arm, and hand. Examples include writing, using buttons, or opening containers. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Satisfaction with Social Roles and Activities30 days post-fitting
PROMIS Satisfaction with Social Roles and Activities is a self-reported person-centered measure that focuses on satisfaction with performing one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- Assessment of Capacity for Myoelectric Control (ACMC)60 days post-fitting
The proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. ACMC is the only measure that has been validated for individuals with upper limb (UL) loss who use myoelectric control and has been shown to demonstrate good test-retest reliability.
- The Southampton Hand Assessment Procedure (SHAP)60 days post-fitting
The SHAP is a time based test of a standardized protocol of 26 timed activities of daily living (ADL) tasks. The SHAP has a set of "common objects" representative of everyday items for the user to pick up. The results of the SHAP is a score which directly compares the abilities of the subject with those of intact able-bodied individuals as well as more refined scores for six prehensile patterns. A SHAP score of 100 is what an intact person is expected to achieve. This test has been validated for normative data.
- PROMIS Social Isolation60 days post-fitting
PROMIS Social Isolation is a self-reported person-centered measure that focuses on perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Ability to Participate60 days post-fitting
PROMIS Ability to Participate is a self-reported person-centered measure that focuses on perceived ability to perform one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Physical Function - Upper Extremity60 days post-fitting
PROMIS Physical Function - Upper Extremity is a self-reported person-centered measure that focuses on capability to perform activities that require use of the upper extremity including shoulder, arm, and hand. Examples include writing, using buttons, or opening containers. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.
- PROMIS Satisfaction with Social Roles and Activities60 days post-fitting
PROMIS Satisfaction with Social Roles and Activities is a self-reported person-centered measure that focuses on satisfaction with performing one's usual social roles and activities. Responses are scored on a scale of 1 to 5. Individual response scores are summed to get a raw score, which can be converted to a standardized T-score with a mean of 50 and standard deviation of 10.