{"id":149,"date":"2025-10-10T04:03:40","date_gmt":"2025-10-10T04:03:40","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/rehabglove\/?page_id=149"},"modified":"2026-05-05T01:49:33","modified_gmt":"2026-05-05T01:49:33","slug":"design-inputs-new-test","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/rehabglove\/design-inputs-new-test\/","title":{"rendered":"Design Inputs"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
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Requirement<\/strong><\/div>\n<\/td>\n
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Specification(s)<\/strong><\/div>\n<\/td>\n
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Verification Activity<\/strong><\/div>\n<\/td>\n
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Validation Activity<\/strong><\/div>\n<\/td>\n<\/tr>\n
1.<\/strong> The device must measure hand and wrist positions.<\/td>\n1.<\/strong> The device must have \u2264 8 mm3<\/sup><\/td>\n1.<\/strong> Using a silicone hand model, compare device acquired position to a known distance using a ruler. <\/td>\n1.<\/strong> User survey if position data is representative and present after the hand is moved.<\/td>\n<\/tr>\n
1. <\/strong><\/strong>Accurate position measurements is essential for deriving secondary kinematic data, such as joint angles and velocity.<\/td>\n<\/tr>\n
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2.<\/strong> The device must measure hand and wrists joints range of motion (ROM)<\/div>\n<\/td>\n
2.1<\/strong> Angular accuracy < \u00b15\u00b0 per joint<\/td>\n\n
2.<\/strong> Compare device measured angles to known angles (0\u00b0 to 180\u00b0) set by a precision goniometer<\/div>\n<\/td>\n
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2.<\/strong> Joint exercise and ROM tests for human subjects<\/span><\/p>\n<\/td>\n<\/tr>\n

2.2<\/strong> Angular resolution \u2264 1\u00b0 for fingers, \u2264 2\u00b0 for wrist joints<\/td>\n<\/tr>\n
2. <\/strong>Accurate ROM measurements is essential for therapists to track progress and adjust rehabilitation programs.<\/td>\n<\/tr>\n
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3.<\/strong> The device must calculate velocity of joint movement.<\/div>\n<\/td>\n
3.1<\/strong> Linear velocity of 0-50 cm\/s \u00b1 1 cm\/s<\/span><\/td>\n3.<\/strong> Compare device calculated linear and angular velocities against linear actuator and motorized goniometer reference values<\/span><\/td>\n\n
3.<\/strong> User performing tendon gliding exercises, testing if velocities are reported<\/div>\n<\/td>\n<\/tr>\n
3.2<\/strong> Angular velocity calculation of 0-20 deg\/s \u00b1 1 deg\/s<\/span><\/td>\n<\/tr>\n
3.<\/strong> To detect abnormal timing\/rhythm, ensure safe exercise intensity, and aid in providing corrective feedback<\/td>\n<\/tr>\n
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4.<\/strong> The device must have an adjustable resistance mechanism to increase difficulty for finger movement.<\/div>\n<\/td>\n
4.1<\/strong> Must have finger flexion resistance force range 0 to 40 N<\/td>\n\n
4.<\/strong> Tensile testing to measure max resistance force, compared to specification with a safety factor.<\/div>\n<\/td>\n
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4.<\/strong> Confirming that human subjects can independently adjust the resistance mechanism during supervised testing<\/span><\/p>\n<\/td>\n<\/tr>\n

4.2<\/strong> Must have finger extension resistance force range 0 to 22 N<\/td>\n<\/tr>\n
4.3<\/strong> Have resistive element adjustable by user<\/td>\n<\/tr>\n
4.<\/strong> To personalize therapy intensity to patient needs, recovery stages, and therapeutic goals.<\/td>\n<\/tr>\n
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5.<\/strong> The device must provide feedback during exercises performed by user.<\/div>\n<\/td>\n
5.1<\/strong> Visual, auditory, or tactile message sent to user if cadence or ROM exceeds therapeutic thresholds or to continue exercises<\/td>\n5.1<\/strong> Use of a hand model or user\u2019s hand within and beyond exercise thresholds to record if appropriate feedback signals are generated<\/td>\n\n

5.<\/strong> Confirming that the device provides real-time corrective or reinforcing feedback while subjects perform exercises<\/span><\/p>\n<\/td>\n<\/tr>\n

5.2<\/strong> Feedback latency \u2264 250 ms (near real time)<\/td>\n5.2<\/strong> Measure the time delay between when the threshold was reached and the feedback response<\/td>\n<\/tr>\n
5.<\/strong> Feedback has been shown to reduce errors and support motor learning during rehabilitation.<\/td>\n<\/tr>\n
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6.<\/strong> The device must fit adult arthritis\/hand injury patient<\/div>\n<\/td>\n
6.1<\/strong> Accommodates hand circumference 15cm \u2013 25cm<\/td>\n\n
6. <\/strong>N\/A<\/div>\n<\/td>\n
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6.<\/strong> Fit testing across a range of hand sizes will confirm the device can accommodate different hand sizes without discomfort or restriction<\/span><\/p>\n<\/td>\n<\/tr>\n

6.2<\/strong> Accommodates hand breadth 6cm \u2013 11cm<\/td>\n<\/tr>\n
6.3<\/strong> Accommodates hand length 15cm-24cm<\/td>\n<\/tr>\n
6.<\/strong> To accommodate natural variations in hand dimensions as well as patients with hand swelling, arthritis deformations, or anatomical changes.<\/td>\n<\/tr>\n
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7.<\/strong> The device must allow users to independently don and doff the glove quickly.<\/div>\n<\/td>\n
7.1<\/strong> Unassisted donning system<\/td>\n\n
7. <\/strong>N\/A<\/div>\n<\/td>\n
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7.<\/strong> Usability testing will validate that participants can independently don and doff the device within 60 seconds<\/span><\/p>\n<\/td>\n<\/tr>\n

7.2<\/strong> Donning time \u2264 60 seconds<\/td>\n<\/tr>\n
7.<\/strong> Ease of donning and doffing is consistently identified as a major barrier to use in rehab gloves.<\/td>\n<\/tr>\n
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8.<\/strong> The hand component of device must be lightweight.<\/div>\n<\/td>\n
8.1<\/strong> The device must have a mass of \u2264500g on the hand<\/td>\n\n
8.<\/strong> Weigh the complete hand-worn device using a precision digital scale. Determine and compare the CoM of the device attached to hand to the CoM of a hand.<\/div>\n<\/td>\n
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8.<\/strong> N\/A<\/div>\n<\/td>\n<\/tr>\n
8.2<\/strong> The device must alter the natural center of mass of the hand by \u2264 10% of hand length<\/td>\n<\/tr>\n
8.<\/strong> Avoids adding excess mass that would restrict natural hand motion and\/or increase strain on the user.<\/td>\n<\/tr>\n
9.<\/strong> The device must meet IEC 60601-1 standards and limit electrical leakage for safe skin contact<\/td>\n9.<\/strong> The device must have \u22640.1 mA of leakage current1<\/span><\/td>\n9.<\/strong> Measure device leakage currents connected to simulated human conditions under normal and single fault conditions<\/td>\n9<\/strong>. No validation activity is performed for this input<\/td>\n<\/tr>\n
 9.<\/strong> Addresses safety concerns regarding potential body contact with electrical components<\/td>\n<\/tr>\n
10.<\/strong> The device must meet ANSI\/AAMI ST98 <\/span>standards to withstand routine disinfection \u00b9<\/span><\/td>\n10.<\/strong> Must maintain integrity after \u2265 70% isopropyl alcohol wipes<\/td>\n10.<\/strong> Apply artificial soil and perform standardized ST98 cleaning cycles to confirm that visible residue is removed and materials do not degrade<\/td>\n10.<\/strong> Confirming that device function and appearance remain unchanged after at least 15 sanitation cycles<\/td>\n<\/tr>\n
10.<\/strong> Addresses safety concerns and performance concerns regarding contact with water\/sweat<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Requirement Specification(s) Verification Activity Validation Activity 1. The device must measure hand and wrist positions. 1. The device must have \u2264 8 mm3 1. Using a silicone hand model, compare device acquired position to a known distance using a ruler.  1. User survey if position data is representative and present after the hand is moved. … <\/p>\n

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