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

Summary

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.

Conditions

• Stroke
• Stroke, Acute
• Balance; Distorted
• Balance; Impairment
• Gait, Unsteady

Interventions

DEVICE

Body weight support system control group

Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.

DEVICE

Body weight support system with balance perturbations

Participants will complete the physical therapy exercises as described previously, while experiencing intermittent, therapist induced, balance perturbations aimed at training the participant's balance-control and balance-reactions. With the ZeroG BWSS integrated TRiP module, therapist's are able to induce safe lateral, anterior, or posterior perturbations via a Wi-Fi-enabled handheld device. The force, or level, of perturbation can be adjusted from 1 (least amount of force) up to 10 (highest amount of force) using the same handheld device,

Sponsors & Collaborators

• Medstar Health Research Institute

  collaborator OTHER

• St. Luke's Rehabilitation Institute

  collaborator OTHER

• Spaulding Rehabilitation Hospital

  collaborator OTHER

• Gaylord Hospital, Inc

  lead OTHER

Principal Investigators

• Pete Grevelding, MSPT · Gaylord Hospital, Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-15

Primary Completion

2023-11-06

Completion

2023-11-06

FDA Device

Yes

Countries

• United States

Study Locations