Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke
Completed · Not applicable
Conditions studied: Stroke, Balance; Distorted
In brief
Strokes are neurological events that can lead to devastating physical and cognitive deficits, such as the inability to ambulate, impaired balance regulation, and loss of coordination. Due to the physical and cognitive deficits experienced following a stroke, many require admission to an inpatient rehabilitation facility to maximize their independence before returning to the home setting. The ability to walk, stand, climb stairs, and other mobility-related functional tasks, are critical components of achieving this functional independence. However, it is often difficult for post-stroke patients with balance impairments to safely practice balance and gait training without putting both therapists and patients at risk for injury. Incorporating robotic technologies to neurological rehabilitation can play a critical role in delivering safe and effective gait and balance therapy. Body-weight support systems (BWSSs) unload paretic lower limbs, patients with gait impairments can practice a higher repetition of steps in a safe, controlled manner. As participants perform gait training, these systems support the participant's body-weight, permitting those with excessive weakness and poor coordination, to ambulate and perform more intensive therapy sessions sooner in their recovery, with minimal risk injurious fall. In addition to BWSSs, balance perturbation systems, which purposefully unbalance participants so to rehabilitate their postural control, have been used to improve gait and balance-control after stroke, or other age and disease related balance impairments. The goal of this study was to evaluate the efficacy of a recently developed, not yet reported, balance perturbation module for the ZeroG BWSS. This new balance perturbation training module is directly integrated into the ZeroG BWSS and allows for the direct induction of safe lateral, anterior, and/or posterior perturbations via a Wi-Fi-enabled handheld device. During both stationary and ambulatory activities, this system was used unbalance participants in order to train their balance-control and balance-reactions. The purpose of this pilot study was to determine if this newly developed BWSS balance perturbation system more effectively rehabilitates participant gait and balance after stroke than the standard BWSS protocol without perturbations.
Key facts
- Study ID
- NCT04919161
- Run by
- Gaylord Hospital, Inc
- People needed
- 32
- Starts
- 2019-10-03
- Expected to finish
- 2020-08-28
- Last updated by the study team
- 2021-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Admission Berg Balance Scale score of 21 or greater
- 18 years of age or older
- Be able to understand and respond to simple verbal instructions in any language
- Be able to physically tolerate and actively participate in at least three, 30 minute weekly sessions in the ZeroG body weight support system
You may not qualify if…
- Cognitive deficits that would disrupt the ability to provide informed consent
- Admission Berg Balance Scale score less than 21
- Uncontrolled hypotension
- Uncontrolled hypertension
- Unstable skin structure (i.e. skin grafts, chest tubes)
- Unstable rib or lower extremity fractures
- Osteoporosis
- Active enteric infection control precautions
- New limb amputations
- Need for greater than 50% high flow oxygen
- Body weight greater than 450 pounds (structural limitations of the ZeroG body weight support system)
Where it is running
- Gaylord Hospital — Wallingford, Connecticut, United States
Full record on ClinicalTrials.gov
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