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Microprocessor controlled knee ankle foot orthosis (KAFO) versus stance control versus locked KAFO: a randomized controlled trial
Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, Semik P, Heinemann AW, Jayaraman A
Archives of Physical Medicine and Rehabilitation 2021 Feb;102(2):233-244
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the potential of a microprocessor swing and stance controlled knee-ankle-foot orthosis (MPO) to improve balance, functional mobility, and quality of life in individuals with lower-extremity impairments as compared to a stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO) over a use-period of a month. DESIGN: Randomized crossover study. SETTING: Ambulatory research laboratory and home and community for community-dwelling adults. PARTICIPANTS: Persons (N = 18) who actively used a unilateral KAFO or SCO for impairments due to neurologic or neuromuscular disease, orthopedic disease, or trauma. Intervention: Participants were trained to acclimate and use SCO and MPO. MAIN OUTCOME MEASURES: The 6-minute walk test (6MWT), 10-m walk test, Berg Balance Scale (BBS), Functional Gait Assessment (FGA), Hill Assessment Index, Stair Assessment Index (SAI), Five Times Sit to Stand Test, Crosswalk Test, Modified Falls Efficacy Scale, Orthotic and Prosthetic User's Survey (OPUS), and World Health Organization Quality of Life (WHQOL)-BREF Scale. RESULTS: Significant changes were observed in participants' self-selected gait speed (p = 0.023), BBS (p = 0.01), FGA (p = 0.002), and SAI (p < 0.001) between baseline and post-MPO assessment. Similar significant differences were seen when comparing post-MPO with post-SCO data. During the 6MWT, persons using the MPO walked significantly longer (p = 0.013) than when using their baseline device. Participants reported higher quality of life scores in the OPUS (p = 0.02) and physical health domain of the WHOQOL-BREF (p = 0.037) after using the MPO. Participants reported fewer falls when wearing the MPO (5) versus an SCO (38) or locked KAFO (15). CONCLUSIONS: The MPO may contribute to improved quality of life and health status of persons with lower-extremity impairments by providing the ability to have better walking speed, endurance, and functional balance.

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