To Assess the Utility of the Point Digit in a Clinical Take-home Study
Phase: NA
Conditions: Amputation; Traumatic, Hand
Sponsor: Point Designs

Cover Page 
Official Title of the Study: To Assess the Utility of the Point Digit in a Clinical Take-home Study 
Document Date: March 15, 2019 
NCT Number: NCT04755790 

Protocol Template 
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Protocol #: 
Project Title: 
The Point Digit: A Family of Ratcheting Prosthetic Finger Technology 
Principal Investigator:  Levin Sliker 
Version Date: 8/2/2018 
I. Hypotheses and Specific Aims:  The purpose of this research is to study the use of passive 
prosthetic devices.  The design of passive prosthetic devices for  amputees will be tested by 
human subjects for strength, function, and durability.  The hypothesis of the study asks whether 
certain design features can withstand activities of daily living.  Examples of activities include 
lifting objects, pouring water, turning keys, etc.    
II. Background and Significance: There are approximately 500,000 people living with minor
upper limb loss in the USA [1],[2].  Minor upper limb loss (also partial hand amputation) is defined 
as the amputation of the bones distal to the wrist joint.  While the field refers to these types of 
amputation as ‘minor,’ it can be a severe disability, especially if the amputation involves the thumb 
and/or multiple digits.  In fact, partial hand amputees self-report a higher level of disability 
compared to other major unilateral upper limb amputees [3].  Furthermore, it was reported that 
fewer than half of partial hand amputees were able to return to the same job after amputation and 
most found that the prosthetic devices were insufficient to meet the demands of their work [4]. 
Amputation can cause physical, psychosocial, and economic damage to an individual and can lead 
to depression, anxiety, loss of self-esteem, and social isolation [5],[6]. While the number of 
individuals with partial hand amputation is 10 times more than all other categories of upper limb 
amputation combined, the state of available technology for this underserved patient population is 
relatively poor [7].  
Current partial hand prostheses are limited in several ways. First, they generally lack robustness, 
and there are frequent reports of devices breaking under normal use. Second, most current options 
offer a one-size-fits-all approach, which limits the acceptance by people who want a prosthesis that 
matches their original finger size. A complete lack of prosthetic finger options can occur for women 
with smaller anatomical size. Third, rotation of the finger about the anatomical center of rotation of 
the metacarpophalangeal (MCP) joint is not possible with current options resulting in a prosthesis 
that is frequently too long. Fourth, current prostheses require the use of the opposite hand to 
operate the device. There is a need for a durable, scalable, anatomically suitable for women, 
single-handedly operable prosthetic finger. 
[1] 
K. Ziegler-Graham, E. J. MacKenzie, P. L. Ephraim, T. G. Travison, and R. Brookmeyer, 
“Estimating the prevalence of limb loss in the United States: 2005 to 2050,” Arch. Phys. Med. 
Rehabil., vol. 89, no. 3, pp. 422–429, 2008. 
[2] 
M. P. LaPlante and D. Carlson, “Disability in the United States: Prevalence and Causes, 
1992. Disability Statistics Report 7.,” Aug. 1996. 
[3] 
J. Davidson, “A comparison of upper limb amputees and patients with upper limb injuries 
using the Disability of the Arm, Shoulder and Hand (DASH),” Disabil. Rehabil., vol. 26, no. 14–15, 
pp. 917–923, Jul. 2004. 
[4] 
H. Burger, T. Maver, and Č. Marinček, “Partial hand amputation and work,” Disabil. 
Rehabil., vol. 29, no. 17, pp. 1317–1321, Jan. 2007. 
[5] 
D. Desmond and M. MacLachlan, “Psychological issues in prosthetic and orthotic practice: 
A 25 year review of psychology in Prosthetics and Orthotics International,” Prosthet. Orthot. Int., 
vol. 26, no. 3, pp. 182–188, Dec. 2002. 
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[6] 
C. M. Parkes, “Psycho-social Transitions: Comparison between Reactions to Loss of a 
Limb and Loss of a Spouse,” Br. J. Psychiatry, vol. 127, no. 3, pp. 204–210, Sep. 1975. 
[7] 
Committee on the Use of Selected Assistive Products and Technologies in Eliminating or 
Reducing the Effects of Impairments, Board on Health Care Services, Health and Medicine 
Division, and National Academies of Sciences, Engineering, and Medicine, The Promise of 
Assistive Technology to Enhance Activity and Work Participation. Washington, D.C.: National 
Academies Press, 2017. 
 
 
III. Preliminary Studies/Progress Report:   
 
IV. Research Methods 
 
A.  Outcome Measure(s):   
Outcome measures include completion rate, completion time, SHAP score, DASH score, box and 
blocks test, clothespin test, and other measures of function.  These metrics quantify the 
performance of prosthetic devices. 
 
B. Description of Population to be Enrolled:   
 
The subject population will consist of a convenient sample of people. The subjects will have various 
ethnicity, age, and gender. An estimated total of 30 subjects will be enrolled. The subjects must be 
normal intact individuals and/or persons with amputation who are able to understand and follow 
directions in English, assessed by their ability to respond during the recruitment and consent 
process. Exclusion criteria include any subjects that are not able to understand the procedures 
and/or are less than 18 years of age. 
 
C. Study Design and Research Methods   
 
The experiments will take place at the Point Designs LLC headquarters, at partner clinics, and/or at 
home. The participant will come up to 3 times for up to 4 hour sessions. During this session the 
participant will be asked to perform activities of daily living in a laboratory setting. The only 
devices/materials coming into contact with the participant will be standard of care 
orthopedic/prosthetic equipment including gauze, casting tape, medical tape, prosthetic sockets.  
Risks from the above devices are possible minor skin discomfort.  Standard of care procedures will 
be used to mount the prosthetic device. A training period will be followed by several tests to 
measure the function of the prosthetic device. Different versions of the device may be presented to 
the subject in a randomized order.  
  
D.   Description, Risks and Justification of Procedures and Data Collection Tools: 
 
Risks from the above devices are possible minor skin discomfort. If you feel that 
you have been harmed while participating in this study, you should inform Levin Sliker at 
720-600-4753 immediately. 
 
    
E.   Potential Scientific Problems:   
 
Potential scientific problems include a lack of subjects with amputation and/or a lack of ability 
to perform the activities of daily living with the prosthetic devices.   
 
F.   Data Analysis Plan:   
 
Data will be processed with standard statistical methods using MATLAB (Mathworks, 
Inc.) in order to produce the metrics described previously (completion rate, completion 
time, etc.) 

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G.  Summarize Knowledge to be Gained:   
 
The development of more functional/robust prosthetic devices will augment the quality 
of life for people with amputation. 
 
 H. References: 
 
N/A