Clinical biomechanics (Bristol, Avon) · 2025
Safety and efficacy of vibrotactile feedback for adults with transtibial amputation: A randomized controlled cross-over trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Penasso Harald, Peternell Gerfried, Schultheis Rainer, Pitschl Aaron, Leskovar Ruth, Gardetto Alexander, Ernst Jennifer, Schmid-Zalaudek Karin, Schaden Wolfgang
Аннотация
BACKGROUND: Pain, social integration, and walking safely with divided attention challenge people with lower-limb amputation. Tactile feedback systems aim to improve sensations and rehabilitation by facilitating prosthesis utility and embodiment. The non-invasive vibrotactile feedback device Suralis® (Saphenus Medical Technology, Vienna, Austria) aims to improve gait, postural control, and pain treatment. This randomized controlled cross-over trial investigated 60-day effects of vibrotactile ground-contact feedback on gait performance and quality of life in adults with unilateral transtibial amputation without targeted reinnervation.
METHODS: We conducted gait assessments before and after the unblinded intervention period and compared within-period changes to the control period without intervention, separated by a one-week washout. The primary outcome substitute was affected-leg stance time, and secondary outcome measures included instrumented-walkway gait speed and four-square-step-test. The trial enrolled 18 participants during the COVID-19 pandemic and ended prematurely due to limitations in recruitment and integrity of the substituted primary outcome between-leg stance time difference.
FINDINGS: Five participants ended the study prematurely, the dropouts were unrelated to adverse events where one experienced concentration difficulties. Analyzing 13 participants showed that participants walking slower than 1.41 ms-1 [1.34 ms-1, 1.49 ms-1] [95 % highest-density interval] with affected-leg stance times above 0.64 s [0.58 s, 0.69 s] responded most positively. Four-square-step-test times had the largest within-period effect size (mean 0.89; [0.44, 1.34] for 0.5 s [0 s, 1 s] improvement), followed by period-one (-0.37; [-0.56, -0.18]), and treatment (0.28; [0.095, 0.46]). Affected-leg stance time did not change (0.21; [-0.26, 0.66]).
INTERPRETATION: Despite the learning effects present, vibrotactile feedback had a small positive effect on functional balance and gait performance in slower-walking participants.
TRIAL REGISTRATION: The trial funded by the Austrian workers' compensation board AUVA and supported by Saphenus Medical Technology was retrospectively registered on clinicaltrials.gov (no. NCT05895253; registration date: 19.05.2023) after a premature termination due to the limited availability of participants during the COVID 19 pandemic.
METHODS: We conducted gait assessments before and after the unblinded intervention period and compared within-period changes to the control period without intervention, separated by a one-week washout. The primary outcome substitute was affected-leg stance time, and secondary outcome measures included instrumented-walkway gait speed and four-square-step-test. The trial enrolled 18 participants during the COVID-19 pandemic and ended prematurely due to limitations in recruitment and integrity of the substituted primary outcome between-leg stance time difference.
FINDINGS: Five participants ended the study prematurely, the dropouts were unrelated to adverse events where one experienced concentration difficulties. Analyzing 13 participants showed that participants walking slower than 1.41 ms-1 [1.34 ms-1, 1.49 ms-1] [95 % highest-density interval] with affected-leg stance times above 0.64 s [0.58 s, 0.69 s] responded most positively. Four-square-step-test times had the largest within-period effect size (mean 0.89; [0.44, 1.34] for 0.5 s [0 s, 1 s] improvement), followed by period-one (-0.37; [-0.56, -0.18]), and treatment (0.28; [0.095, 0.46]). Affected-leg stance time did not change (0.21; [-0.26, 0.66]).
INTERPRETATION: Despite the learning effects present, vibrotactile feedback had a small positive effect on functional balance and gait performance in slower-walking participants.
TRIAL REGISTRATION: The trial funded by the Austrian workers' compensation board AUVA and supported by Saphenus Medical Technology was retrospectively registered on clinicaltrials.gov (no. NCT05895253; registration date: 19.05.2023) after a premature termination due to the limited availability of participants during the COVID 19 pandemic.