{"id":91,"date":"2025-11-03T01:16:39","date_gmt":"2025-11-03T01:16:39","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/stepwise\/?page_id=91"},"modified":"2025-11-03T01:34:20","modified_gmt":"2025-11-03T01:34:20","slug":"requirements","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/stepwise\/requirements\/","title":{"rendered":"Design Inputs"},"content":{"rendered":"\n
Requirement<\/strong><\/td>Specification<\/strong><\/td>Justification<\/strong><\/td><\/tr>
1. The device must allow adjustment of plantarflexion and dorsiflexion to match the patient\u2019s current phase of rehabilitation.<\/td>Three discrete, clinician-supervised ROM settings for plantarflexion and dorsiflexion<\/span><\/strong> angles.<\/td>– Current treatments progress from full immobilization (casting, walking boot) to semi-rigid bracing and then to functional rehab devices.
– Adjustable ROM improves compliance and reduces stiffness, muscle wasting, and reinjury risk compared to rigid immobilization.<\/td><\/tr>
2. The device must allow adjustment of abduction and adduction to match the patient\u2019s current phase of rehabilitation.<\/td>Three discrete, clinician-supervised ROM settings for abduction and adduction<\/span><\/strong> angles.<\/td>– Midfoot and forefoot motion (abduction\/adduction) contributes to ankle instability and functional deficits after sprain.
– Ignoring transverse control can increase the chance of reinjury.<\/td><\/tr>
3. The device must allow adjustment of inversion and eversion to match the patient\u2019s current phase of rehabilitation.<\/td>Three discrete, clinician-supervised ROM settings for inversion and eversion<\/span><\/strong> angles.<\/td>– Lateral stability and support is key for reducing risk of reinjury.
– Lateral bracing for functional recovery increases patient satisfaction.<\/td><\/tr>
4. The device must actively assist the ankle range of motion during the active recovery phase.<\/td>A) Actively support patient rehabilitation from near immobilization stage to near full mobility stage.
B) Limit assisted angular velocity.<\/td>		– Powered ankle orthoses significantly increased the patient range of motion and gait when combined with neuromuscular training.
– Managed angular velocity to prevent reinjury and assist recovery.<\/td><\/tr>
5. The device must tolerate loads without loss of structural integrity.<\/td>A) Withstand loads of up to 3-5\u00d7 patient body weight.
B) Safe use for patients up to 250 lbs.<\/td>		– Failure under normal loads would compromise ankle support and increase reinjury risk.
– Reliable load capacity is critical for safe, everyday use.<\/td><\/tr>
6. The device must be lightweight.<\/td>A) Limit device weight to less than 2 kg.
B) Limit distal weight.<\/td>		– Excessive weight alters gait patterns and can cause injuries in the knees or hips.
– Excess weight at the distal end negatively affects the metabolic cost of the swing phase.
– Lightweight devices improve compliance and user comfort.<\/td><\/tr>
7. The device must be comfortable.<\/td>A) Limit ankle-device interface pressure.
B) Continuous use for \u22648 hours per day without tissue damage.<\/td>		– Comfort and fit are among the most important factors in compliance.
– Poor comfort leads to noncompliance rates up to 80% in lower-limb orthotic users.
– Patient adherence is essential to recovery.<\/td><\/tr>
8. The device must allow fast switching between the three rehabilitation phase modes.<\/td>A) Acute Phase: Near Zero Mobility
B) Sub-Acute Phase: Partial Mobility
C) Functional Phase: Near Full Mobility
D) Time for manual clinician adjustment between modes is less than 1 minute<\/td>		– Current treatments progress from full immobilization (casting, walking boot) to semi-rigid bracing and then to functional rehab devices<\/td><\/tr>
9. The device must constrain the range of motion of the ankle to match the patient’s current phase of rehabilitation.<\/td>A) Acute Phase: 0-5\u00b0 in all axes
B) Sub-Acute Phase: Clinician Defined
C) Functional Phase:
     i. 15-20\u00b0 \/ PF 45-50\u00b0
      <\/sup>ii. Inv: 30\u00b0 \/ Ev: 30\u00b0
     iii. Abd: 15\u00b0 \/ Add: 35-40\u00b0<\/td>		– Powered ankle orthoses significantly increased the patient range of motion and gait when combined with neuromuscular training<\/td><\/tr>
10. The device must provide a controllable active element capable of assisting the patient through a prescribed range of motion during the sub-acute phase.<\/td>A) Patient rehabilitation ROM:
(Range for Set Points) 
i. DF 0-20\u00b0 \/ PF 0-50\u00b0
ii. Inv: 0-30\u00b0 \/ Ev: 0-30\u00b0
  iii. Abd: 0-15\u00b0 \/ Add: 0-40\u00b0
B) Limit assisted ankle angular velocity to \u226410\u00b0\/sec (clinician-adjustable)<\/td>		Adjustable ROM improves compliance and reduces stiffness, muscle wasting, and reinjury risk compared to rigid immobilization.<\/td><\/tr>
11. The device must allow clinicians to set a custom range of motion boundary for each plane of motion within the sub-acute phase.<\/td>A) Sub-Acute Phase: Partial Mobility
i. DF 0-20\u00b0 \/ PF 0-55\u00b0
ii. Inv: 0-30\u00b0 \/ Ev: 0-30\u00b0
iii. Abd: 0-15\u00b0 \/ Add: 0-40\u00b0 
B) Clinician-prescribed adjustment.<\/td>		– Clinician-defined ROM limits enable personalized progression based on patient tolerance and recovery metrics.<\/td><\/tr>
12. The device must include a fail-safe that prevents motion beyond clinician-set limits.<\/td>A) Independent hard-stop that physically enforces the ROM limits regardless of software\/electronics. 
B) Not exceed more than .5 degrees beyond the constrained range of motion.<\/td>		– A hard-stop provides safety independent of power, preventing over-rotation and unintended progression between phases.<\/td><\/tr>
13. The device must include an emergency shut-off mechanism that rapidly stops all powered motion.<\/td>A) One single-action control (button\/toggle) must cut power or pressure to the active components of the system.
B) Located within easy reach of the user.
C) Cuts the operation of the device within less than 5 seconds.<\/td>		– Rapid interruption of powered motion is critical for patient safety during active rehab. A clearly marked shut-off allows for immediate response to unexpected pain or malfunction.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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Requirement Specification Justification 1. The device must allow adjustment of plantarflexion and dorsiflexion to match the patient\u2019s current phase of rehabilitation. Three discrete, clinician-supervised ROM settings for plantarflexion and dorsiflexion angles. – Current treatments progress from full immobilization (casting, walking boot) to semi-rigid bracing and then to functional rehab devices.– Adjustable ROM improves compliance and […]<\/p>\n","protected":false},"author":663,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-91","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/pages\/91","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/users\/663"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/comments?post=91"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/pages\/91\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/media?parent=91"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}