To Evaluate the Clinical Impact of the Point Powered System
- Conditions
- Amputation; Traumatic, Hand
- Registration Number
- NCT07135947
- Lead Sponsor
- Point Designs
- Brief 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 (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Ability to Participate 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 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 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.
PROMIS Social Isolation 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.
- Secondary Outcome Measures
Name Time Method Mean Prosthesis Wear Duration (MPWD) Through study completion, an average of 3 months 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.
Bilateral magnitude (BM) Through study completion, an average of 3 months 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.
Magnitude ratio (MR) Through study completion, an average of 3 months 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.
Secondary activity duration variables Through study completion, an average of 3 months 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.
Trial Locations
- Locations (3)
University of Colorado Denver | Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Point Designs
🇺🇸Broomfield, Colorado, United States
Hanger Clinic
🇺🇸Lafayette, Colorado, United States
University of Colorado Denver | Anschutz Medical Campus🇺🇸Aurora, Colorado, United StatesStephen HuddleContact303-724-5893STEPHEN.HUDDLE@cuanschutz.eduRichard Weir, PhDPrincipal Investigator