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

NCT05110300 | Terminated Results FDA Device

• 1 other identifier: 202108GRE
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Stroke Rehabilitation; Neurological Rehabilitation; Gait and Ambulation; Balance Impairment; Postural Balance Impairment; Postural Balance Perturbation; Gait Perturbation; Body Weight Support System; Activities of Daily Living; Occupational Therapy; Physical Therapy; Long-term Acute Care Hospital; Inpatient Rehabilitation Facility; Berg Balance Scale; Activity specific balance confidence scale; 10 meter walk test

Outcome Measures

Primary Outcomes (3)

• Berg Balance Scale Pre-intervention Assessment Scores

  The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible.

  Baseline (within 72 hours of admission)

• Berg Balance Scale Post-intervention Assessment Scores

  The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible.

  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

  The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible. Admission and discharge Berg scores are collected from a chart review within 48 hours of participant discharge. The change in Berg score is calculated by subtracting the participants admission or pre-assessment score from their discharge or post-assessment score: (Post assessment)-(Pre assessment)

  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.

Secondary Outcomes (12)

• Activities Specific Balance Scale (ABC) Pre-intervention Scores

  The pre-assessment ABC Scale will be collected within 48 hours of the first study session.

• Activities Specific Balance Scale (ABC) Post-intervention Scores

  The post-assessment ABC Scale will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.

• Difference in Activities-Specific Balance Confidence (ABC) Scale Score Change

  The pre-assessment ABC Scale will be conducted within 48 hours prior to the first study session. The post-assessment ABC scale will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.

• 10 Meter Walk Test (10MWT) Pre-intervention Scores

  The pre-assessment 10MWT will be conducted by site investigators within 48 hours prior to the first study session.

• 10 Meter Walk Test (10MWT) Post-intervention Scores

  The post-assessment 10MWT will be collected within 48 hours of the last study session or discharge from the health system, on average, 17 days.

Study Arms (2)

Body weight support system control group

ACTIVE COMPARATOR

The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.

Device: Body weight support system control group

Body weight support system with balance perturbations

EXPERIMENTAL

The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).

Device: Body weight support system with balance perturbations

Interventions

Body weight support system control group DEVICE

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

Also known as: ZeroG, BWSS, BWSS control, Zero G

Body weight support system control group

Body weight support system with balance perturbations DEVICE

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,

Also known as: ZeroG with training response in postural rehabilitation, ZeroG - TriP, ZeroG TriP, BWSS-P, BWSS+P, Zero G TRiP, Zero G - TRiP, TRiP

Body weight support system with balance perturbations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead
• Medstar Health Research Institute: collaborator
• St. Luke's Rehabilitation Institute: collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (4)

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Spaulding Rehabilitation Hospital

Sandwich, Massachusetts, 02537, United States

Location

Providence St. Luke's Rehabilitation Medical Center

Spokane, Washington, 99202, United States

Location

Related Publications (15)

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• Esmaeili V, Juneau A, Dyer JO, Lamontagne A, Kairy D, Bouyer L, Duclos C. Intense and unpredictable perturbations during gait training improve dynamic balance abilities in chronic hemiparetic individuals: a randomized controlled pilot trial. J Neuroeng Rehabil. 2020 Jun 17;17(1):79. doi: 10.1186/s12984-020-00707-0.

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• Landers MR, Oscar S, Sasaoka J, Vaughn K. Balance Confidence and Fear of Falling Avoidance Behavior Are Most Predictive of Falling in Older Adults: Prospective Analysis. Phys Ther. 2016 Apr;96(4):433-42. doi: 10.2522/ptj.20150184. Epub 2015 Aug 20.

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  PMID: 18566951 BACKGROUND

• Chien JE, Hsu WL. Effects of Dynamic Perturbation-Based Training on Balance Control of Community-Dwelling Older Adults. Sci Rep. 2018 Nov 22;8(1):17231. doi: 10.1038/s41598-018-35644-5.

  PMID: 30467355 BACKGROUND

• Shimada H, Obuchi S, Furuna T, Suzuki T. New intervention program for preventing falls among frail elderly people: the effects of perturbed walking exercise using a bilateral separated treadmill. Am J Phys Med Rehabil. 2004 Jul;83(7):493-9. doi: 10.1097/01.phm.0000130025.54168.91.

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• Steib S, Klamroth S, Gassner H, Pasluosta C, Eskofier B, Winkler J, Klucken J, Pfeifer K. Perturbation During Treadmill Training Improves Dynamic Balance and Gait in Parkinson's Disease: A Single-Blind Randomized Controlled Pilot Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):758-768. doi: 10.1177/1545968317721976. Epub 2017 Jul 31.

  PMID: 28758519 BACKGROUND

• Schinkel-Ivy A, Huntley AH, Aqui A, Mansfield A. Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? J Stroke Cerebrovasc Dis. 2019 Apr;28(4):935-943. doi: 10.1016/j.jstrokecerebrovasdis.2018.12.011. Epub 2019 Jan 7.

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• Meyer A, Hrdlicka HC, Cutler E, Hellstrand J, Meise E, Rudolf K, Grevelding P, Nankin M. A Novel Body Weight-Supported Postural Perturbation Module for Gait and Balance Rehabilitation After Stroke: Preliminary Evaluation Study. JMIR Rehabil Assist Technol. 2022 Mar 1;9(1):e31504. doi: 10.2196/31504.

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Related Links

• Data and Safety Monitoring Board (DSMB) Guidelines \| National Institute of Dental and Craniofacial Research
• Stroke Facts, Centers for Disease Control
• Unblinded Quasi-Randomized Pilot Study Exploring the Benefits of the ZeroG TRiP System to Improve Patient Balance Following an Acute Stroke; NCT04919161

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Corbett
• Organization: Gaylord Specialty Healthcare

jcorbett@gaylord.org

2032943224

Study Officials

• Pete Grevelding, MSPT

  Gaylord Hospital, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, subjects and investigators will not be able to be masked to the intervention. The assessor will not be able to be masked to group assignments, as the presence or absence of certain variables in the dataset, namely the perturbation level, will immediately reveal group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a multisite, randomized, active-comparator controlled clinical trial.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 5, 2021
• Study Start: December 15, 2021
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: November 14, 2025
• Results First Posted: April 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)