Amputation; Traumatic, HandNCT07135947
To Evaluate the Clinical Impact of the Point Powered System
A study testing Point Powered partial hand prosthetic system in people with Amputation; Traumatic, Hand, run by Point Designs at 3 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment. This study will be a single subject crossover design where one group of 10 adult partial hand amputees will be evaluated on several metrics on their existing prosthetic treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation; Traumatic, Hand
- What is being tested?
- Point Powered partial hand prosthetic system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partial unilateral hand loss with at least index and/or middle fingers amputated at the MCP level
- Intact thumb with full range of motion
- Fluent in English
- Age of 18 years or older
Who cannot join
- Patients with a residual limb that is unhealed from the amputation surgery
- Unhealed wounds
- 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 clinical evaluation
- Serious uncontrolled medical problems as judged by the project therapist
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, 80045
Stephen Huddle, 303-724-5893, STEPHEN.HUDDLE@cuanschutz.edu
Richard Weir, PhD
Point Designs
Broomfield, Colorado, 80020
Rebecca Connolly, 720-600-4753, becca@pointdesigns.com
Levin Sliker, PhD
Hanger Clinic
Lafayette, Colorado, 80026
Rebecca Connolly, 720-600-4753, becca@pointdesigns.com
About this study
The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment. This study will be a single subject crossover design where one group of 10 adult partial hand amputees will be evaluated on several metrics on their existing prosthetic treatment (Treatment 1) and the Point Powered system (Treatment 2) over a period of three months using standard two-site myoelectric control. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.
- Conditions
- Amputation; Traumatic, Hand
- Being tested
- Point Powered partial hand prosthetic system
- Keywords
- Prosthesis, Myoelectric, Digits, Fingers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point Powered partial hand prosthetic systemDevice
The Point Powered system includes 1-4 3-joint mechatronic digits, low-profile EMG electrodes, a low-profile controller, and flexible batteries. These components will be integrated into a waterproof and dustproof packaging
| Study group | Role | What they receive |
|---|---|---|
| Current/No Device | No intervention | Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device. |
| Point Powered | Experimental | Outcome measurements will be performed after the subject has been fit with the Point Powered at 3 different points in time: immediately post-fitting, ~30 days post-fitting, and ~60 days post-fitting. Receives: Device: Point Powered partial hand prosthetic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Capacity for Myoelectric Control (ACMC)
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.
Measured: Baseline (pre-fitting)
The Southampton Hand Assessment Procedure (SHAP)
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.
Measured: Baseline (pre-fitting)
PROMIS Social Isolation
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.
Measured: Baseline (pre-fitting)
PROMIS Ability to Participate
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.
Measured: Baseline (pre-fitting)
PROMIS Physical Function - Upper Extremity
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.
Measured: Baseline (pre-fitting)
PROMIS Satisfaction with Social Roles and Activities
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.
Measured: Baseline (pre-fitting)
Assessment of Capacity for Myoelectric Control (ACMC)
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.
Measured: Immediately post-fitting
The Southampton Hand Assessment Procedure (SHAP)
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.
Measured: Immediately post-fitting
PROMIS Social Isolation
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.
Measured: Immediately post-fitting
PROMIS Ability to Participate
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.
Measured: Immediately post-fitting
PROMIS Physical Function - Upper Extremity
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.
Measured: Immediately post-fitting
PROMIS Satisfaction with Social Roles and Activities
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.
Measured: Immediately post-fitting
Assessment of Capacity for Myoelectric Control (ACMC)
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.
Measured: 30 days post-fitting
The Southampton Hand Assessment Procedure (SHAP)
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.
Measured: 30 days post-fitting
PROMIS Social Isolation
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.
Measured: 30 days post-fitting
PROMIS Ability to Participate
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.
Measured: 30 days post-fitting
PROMIS Physical Function - Upper Extremity
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.
Measured: 30 days post-fitting
PROMIS Satisfaction with Social Roles and Activities
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.
Measured: 30 days post-fitting
Assessment of Capacity for Myoelectric Control (ACMC)
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.
Measured: 60 days post-fitting
The Southampton Hand Assessment Procedure (SHAP)
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.
Measured: 60 days post-fitting
PROMIS Social Isolation
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.
Measured: 60 days post-fitting
PROMIS Ability to Participate
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.
Measured: 60 days post-fitting
PROMIS Physical Function - Upper Extremity
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.
Measured: 60 days post-fitting
PROMIS Satisfaction with Social Roles and Activities
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.
Measured: 60 days post-fitting
Secondary outcomes (4)
Mean Prosthesis Wear Duration (MPWD)
We will measure the mean duration of daily prosthesis wear as a proxy for improved prosthesis acceptance. Prosthesis wear time is defined as the time from when participants don their prostheses to the time they doff their prostheses. The time points are both recorded by participants and through analysis of the activity monitors. We believe the mean prosthesis wear duration is an important metric as it is possible that participants who have higher levels of satisfaction with their prosthesis will wear their prosthesis for long periods of time. It is also possible that wear time may not necessarily be correlated with corresponding usage of the prosthetic limb. Measuring this variable will be important in its assessment in comparison with other variables.
Measured: Through study completion, an average of 3 months
Bilateral magnitude (BM)
Participants will be asked to wear accelerometers on each wrist throughout the study. From accelerometry data, we will calculate the bilateral magnitude (BM), which quantifies the intensity of activity across both arms for a given duration. A BM of 0 indicates that no activity occurs and increasing BMs indicate that more bilateral activity occurs.
Measured: Through study completion, an average of 3 months
Magnitude ratio (MR)
Participants will be asked to wear accelerometers on each wrist throughout the study. From accelerometry data, we will calculate magnitude ratio (MR), which is the ratio of acceleration between the two arms for a given duration. A MR of 0 indicates equivalent contribution of activity from both arms; positive values of MR indicate that more prosthesis-side activity occurs and negative values of MR indicate that more sound-side activity occurs.
Measured: Through study completion, an average of 3 months
Secondary activity duration variables
In addition to BM and MR, we will also calculate durations of non-injured UL activity, amputated UL activity, simultaneous UL activity, and total UL activity averaged across each day. Measurements of activity durations by UL side can provide additional insight into how much one side is used over another and with respect to bilateral use. This measure is complimentary to BM and MR measures and will help us determine if the Point Powered promotes more use of the prosthesis side relative to the standard-of-care.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Point Designs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Hanger Clinic: Prosthetics & Orthotics, University of Colorado, Denver, Infinite Biomedical Technologies
- Responsible party
- Sponsor
- Investigators
- Levin Sliker, PhD, Principal investigator, Point Designs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135947
- Sponsor's protocol ID
- 348027
- Other IDs
- R44NS122687
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Clinical Impact of the Point Powered System
- ClinicalTrials.gov ID
- NCT07135947
- Acronym / sponsor ID
- 348027
- Conditions
- Amputation; Traumatic, Hand
- Keywords
- Prosthesis, Myoelectric, Digits, Fingers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Point DesignsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Hanger Clinic: Prosthetics & Orthotics, University of Colorado, Denver, Infinite Biomedical Technologies
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment. This study will be a single subject crossover design where one group of 10 adult partial hand amputees will be evaluated on several metrics on their existing prosthetic treatment (Treatment 1) and the Point Powered system (Treatment 2) over a period of three months using standard two-site myoelectric control. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current/No Device | No intervention | –Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device. |
| Point Powered | Experimental | Device: Point Powered partial hand prosthetic systemOutcome measurements will be performed after the subject has been fit with the Point Powered at 3 different points in time: immediately post-fitting, ~30 days post-fitting, and ~60 days post-fitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Partial unilateral hand loss with at least index and/or middle fingers amputated at the MCP level
- Intact thumb with full range of motion
- Fluent in English
- Age of 18 years or older
Key exclusion criteria (7 listed)
- Patients with a residual limb that is unhealed from the amputation surgery
- Unhealed wounds
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point Powered partial hand prosthetic systemThe Point Powered system includes 1-4 3-joint mechatronic digits, low-profile EMG electrodes, a low-profile controller, and flexible batteries. These components will be integrated into a waterproof and dustproof packaging | Device | Point Powered |
Primary outcome
Assessment of Capacity for Myoelectric Control (ACMC)
Time frame: 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)
Time frame: 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 Isolation
Time frame: Baseline (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 Participate
Time frame: Baseline (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 Extremity
Time frame: Baseline (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 Activities
Time frame: Baseline (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)
Time frame: 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)
Time frame: 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 Isolation
Time frame: Immediately 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 Participate
Time frame: Immediately 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 Extremity
Time frame: Immediately 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 Activities
Time frame: Immediately 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)
Time frame: 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)
Time frame: 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 Isolation
Time frame: 30 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 Participate
Time frame: 30 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 Extremity
Time frame: 30 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 Activities
Time frame: 30 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)
Time frame: 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)
Time frame: 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 Isolation
Time frame: 60 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 Participate
Time frame: 60 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 Extremity
Time frame: 60 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 Activities
Time frame: 60 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.
4 secondary outcomes
Mean Prosthesis Wear Duration (MPWD)
Time frame: Through study completion, an average of 3 months
Bilateral magnitude (BM)
Time frame: Through study completion, an average of 3 months
Magnitude ratio (MR)
Time frame: Through study completion, an average of 3 months
Secondary activity duration variables
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Amputation; Traumatic, Hand
Recruiting
To Assess the Utility of the Point Mini in a Clinical Take-home Study
Amputation; Traumatic, Hand, Amputation, Congenital
RecruitingPhase 2
Human Upper Extremity Allotransplantation
Amputation, Traumatic, Wounds and Injuries
RecruitingObservational study
Human Upper Extremity Allotransplantation: F/U Protocol
Amputation, Traumatic, Wounds and Injury
RecruitingPhase 4
Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Amputation; Traumatic, Hand
Recruiting
DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
Amputation; Traumatic, Hand
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Levin Sliker, PhD principal investigator
Point Designs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point Powered partial hand prosthetic system in people with Amputation; Traumatic, Hand, run by Point Designs at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Connolly (720-600-4753, becca@pointdesigns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Capacity for Myoelectric Control (ACMC) (time frame: Baseline (pre-fitting)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.