Abstract

<h3>Research Objectives</h3> To determine if inducing safe postural-perturbations with the TRiP-module during standing and ambulation exercises in the ZeroG body-weight support system, more effectively improves patient balance than ZeroG without these perturbations. <h3>Design</h3> Study was an unblinded randomized control pilot study. <h3>Setting</h3> Study was conducted at Gaylord Specialty Healthcare, a long-term acute care rehabilitation hospital located in Wallingford, Connecticut, USA. <h3>Participants</h3> Inpatient stroke rehabilitation patients were considered for the study if their Berg Balance Scale score was ≥ 21/56. Consented participants were randomly assigned to either the ZeroG or ZeroG+TRiP group. <h3>Interventions</h3> ZeroG interventions consisted of balance activities including ambulation, marching, side-stepping, retro-ambulation, step-taps, and step-ups. ZeroG+TRiP interventions included these same activities, with the addition of a sudden and brief assistive or resistive force in the lateral, anterior, or posterior direction. Participants completed eight-sessions over two-weeks, starting at TRiP level-one and progressing to level-ten based on the participant's progress and therapist's discretion. <h3>Main Outcome Measures</h3> The main study outcomes were the Activities-Specific Balance Confidence (ABC) and Berg Balance Scale assessments. <h3>Results</h3> Institutional Berg Balance data from 2018 served as a historical Standard of Care (SOC) baseline. SOC, ZeroG, and ZeroG+TRiP groups displayed improved post-intervention Berg Balance scores (p≤0.0025), however, the post-intervention scores were not different between groups. Calculating the Berg Balance score percent change [mean(SD)n], the ZeroG+TRiP [66.95%(43.78%)14] and ZeroG groups [53.29%(24.13%)15] were significantly greater than the SOC group [28.31%(17.25%)30] (p≤0.0178), with no difference between the ZeroG groups (p=0.6669). The post intervention ABC assessment scores were similarly improved (p≤0.0438), with no difference between ZeroG groups. <h3>Conclusions</h3> Participants in both ZeroG groups demonstrated similar Berg Balance Scale and ABC score improvements, indicating the TRiP Module is not detrimental to post-acute stroke rehabilitation and can be safely used. This pilot-study then provides the rationale for conducting a larger study to better assess if the TRiP protocol provides an additional benefit to stroke patients during inpatient rehabilitation. <h3>Author(s) Disclosures</h3> Aretech, LLC provided financial assistance for protected time to complete the administrative work associated with this pilot study. Authors have no other disclosures.

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