A Multisite Exploration of Balance Perturbations With and Without Body Weight Support

Stopped early · Not applicable

Conditions studied: Stroke, Stroke, Acute, Balance; Distorted, Balance; Impairment, Gait, Unsteady

In brief

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.

Key facts

Study ID

NCT05110300

Run by

Gaylord Hospital, Inc

People needed

114

Starts

2021-12-15

Expected to finish

2023-11-06

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to one of the listed study locations for inpatient rehabilitation following a stroke.
• Be 18 years of age or older.
• Have at least a moderate fall risk or better, shown by an admission Berg Balance Scale (BBS) score of 21/56 or greater.
• Patients that score below 21 or are non-ambulatory will not be considered for this study.
• Patients that are emergently re-admitted to acute care and subsequently re-admitted to the stroke rehabilitation program will be reassessed for appropriateness of continuation in the study on a case by case basis.
• Patients that progress to a BBS score of 21 or greater during their stay, and have a set discharge date of 10 days or longer, can be approached for study recruitment.
• Appropriate cognition
• Able to read and understand the consent, in English or a language available by translator services, based on the judgement of the clinical team, either by using outcomes measures, i.e. SLUMS greater than or equal to 20, or through clinical evaluations and team discussion. Eligibility will ultimately be decided by the treating physician in combination with the participant's clinical team.
• Ability to tolerate and actively participate in up to six, 30-minute sessions, with physical therapy while using the BWSS.
• Weigh less than 450 pounds, per the structural limitations of the ZeroG system.

You may not qualify if…

• Active seizures
• Spinal stabilization with the use of Halos
• Uncontrolled hypertension or hypotension
• Unstable skin structures (i.e. skin grafts)
• Chest tubes
• Unstable rib or lower extremity fractures
• Severe osteoporosis
• Participants where pressure around the abdomen, thighs, groin, or shoulders in contraindicated
• Cognitive deficits that would disrupt the ability to provide informed consent as described above
• Active enteric infection control precautions
• Subjects would be eligible once precautions are lifted
• Ongoing orthostasis
• New limb amputations
• Vestibular disorders that may impact balance
• Premorbid conditions that may impact balance
• Patients requiring more than 50% high flow oxygen as consistent with inpatient therapy guidelines
• Anyone belonging to a vulnerable population, including inmates, individuals under the age of 18, and who are or might be pregnant

Where it is running

• Gaylord Hospital — Wallingford, Connecticut, United States
• MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States
• Spaulding Rehabilitation Hospital — Sandwich, Massachusetts, United States
• Providence St. Luke's Rehabilitation Medical Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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