Stopped: Interim analysis showed that there was no added benefit to participants, so recruitment was terminated for patient safety.
ZeroG is an FDA-listed robotic body weight support system (BWSS). Mounted on an overhead track, patients are fitted in a harness system tethered to said track, and are able to practice gait and balance activities without the risk of falling. This compensates for ineffective postural control permitting intensive therapy sessions earlier in recovery. The purpose of this study is to determine if inducing effective and safe balance perturbations during standing and walking in the BWSS more effectively improve postural control than the BWSS without perturbations. The target population are those patients in the post-acute phase of stroke admitted for inpatient rehabilitation of balance impairments. Site investigators and/or research staff will obtain names of potential subjects from internal reporting identifying inpatients who may qualify for the study based on the inclusion criteria. Trained site investigators will meet with potential subjects to explain the study, complete a screening interview for exclusion and inclusion criteria, answer any questions, obtain informed consent and HIPAA authorization, and schedule the study therapy sessions involving the protocol. Based on the randomization scheme provided by the lead site, consented subjects will be randomized to either the BWSS with perturbations (BWSS-P) or standard BWSS control without perturbations. Subjects will perform 2 to 6 sessions in their designated intervention using a structured protocol for each session. To compare differences between treatment groups, outcome measures will be collected at baseline before any BWSS sessions are performed and within 48 hours after completing the final treatment session.
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Berg Balance Scale Pre-intervention Assessment Scores
Timeframe: Baseline (within 72 hours of admission)
Berg Balance Scale Post-intervention Assessment Scores
Timeframe: The post-assessment BBS will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.
Difference in Berg Balance Scale Pre-Intervention and Post-Intervention Assessment Scores
Timeframe: The baseline pre-assessment BBS score will be collected within 72 hours of admission, as part of their normal care. The post-assessment will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.