Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke

NCT04919161 | Completed Results FDA Device

• 1 other identifier: 201901Ber
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Balance; Distorted

Keywords

Stroke Rehabilitation; Postural Balance; Gait and Ambulation; Balance Perturbation; Postural Perturbation; Body Weight Support System; Occupational Therapy; Physical Therapy; Long Term Acute Care Hospital; Berg Balance Scale; Activities Specific Balance Confidence Scale; Balance Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.

• Comparison of Berg Balance Scale Assessment Score Changes

  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 using 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 score change between groups was then compared between the two treatment groups

  The pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.

• Differences in the Percent Change of Berg Balance Scale (BBS) 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 using from a chart review within 48 hours of participant discharge. The BBS percent change is calculated using the following formula: \[((Post assessement)-(Pre assessment))/(Pre assessment)\] ×100%

  The pre-assessment Berg Balance Scale score was collected during the initial physical therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment was collected within 24 hours prior to discharge.

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

  The ABC Scale subjectively measures a person's self-perceived balance-confidence to perform various tasks without losing balance or experiencing a sense of unsteadiness; it is based on a rating scale from 0% (no confidence) to 100% (completely confident); higher the score the better.

  The pre-assessment ABC is completed at participant enrollment just prior to first intervention. The post-assessment ABC is completed immediately after final intervention.

Secondary Outcomes (3)

• Toilet Transfer Score

  The pre-assessment Toilet transfer score is collected during the initial occupational therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment is collected within 24 hours prior to discharge.

• Ambulation Score

  The pre-assessment Ambulation score is collected during the initial occupational therapy assessment within 48 hours of admission, as part of their normal care. The post-assessment is collected within 24 hours prior to discharge.

• Perturbation Level Progression

  Perturbation level recordings completed for each of the 8 sessions completed over an average of 2 weeks.

Study Arms (3)

Body weight support system control group

ACTIVE COMPARATOR

In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.

Device: Body weight support system control group

Body weight support system with balance perturbations

EXPERIMENTAL

Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.

Device: Body weight support system with balance perturbations

Historical Standard of Care control

NO INTERVENTION

Retrospective anonymized Berg Balance Score data of stroke inpatients was collected from an institutional report for fiscal year 2018. 2018 was chosen as it preceded the implementation of the ZeroG body weight support system and reflects a no-intervention control baseline. This data was then filtered to show only patients with a Berg score of 21 or greater to match the study's inclusion criteria.

Interventions

Body weight support system control group DEVICE

The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.

Also known as: ZeroG; BWSS; BWSS control

Body weight support system control group

Body weight support system with balance perturbations DEVICE

The BWSS with balance perturbations group conducted the same balance and gait activities 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.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level will be set based on the participant's progress.

Also known as: ZeroG with training response in postural rehabilitation; BWSS-P; BWSS+P

Body weight support system with balance perturbations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission Berg Balance Scale score of 21 or greater
• 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)

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead

Study Sites (1)

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Related Publications (19)

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

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• Alguren B, Lundgren-Nilsson A, Sunnerhagen KS. Functioning of stroke survivors--A validation of the ICF core set for stroke in Sweden. Disabil Rehabil. 2010;32(7):551-9. doi: 10.3109/09638280903186335.

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• 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.

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• 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.

  PMID: 15213472 BACKGROUND

• 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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• 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.

  PMID: 30630753 BACKGROUND

• Mansfield A, Aqui A, Danells CJ, Knorr S, Centen A, DePaul VG, Schinkel-Ivy A, Brooks D, Inness EL, Mochizuki G. Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial. BMJ Open. 2018 Aug 17;8(8):e021510. doi: 10.1136/bmjopen-2018-021510.

  PMID: 30121600 BACKGROUND

• Hidler J, Brennan D, Black I, Nichols D, Brady K, Nef T. ZeroG: overground gait and balance training system. J Rehabil Res Dev. 2011;48(4):287-98. doi: 10.1682/jrrd.2010.05.0098.

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• Anggelis E, Powell ES, Westgate PM, Glueck AC, Sawaki L. Impact of motor therapy with dynamic body-weight support on Functional Independence Measures in traumatic brain injury: An exploratory study. NeuroRehabilitation. 2019 Dec 18;45(4):519-524. doi: 10.3233/NRE-192898.

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• Hutchinson LA, De Asha AR, Rainbow MJ, Dickinson AWL, Deluzio KJ. A comparison of centre of pressure behaviour and ground reaction force magnitudes when individuals walk overground and on an instrumented treadmill. Gait Posture. 2021 Jan;83:174-176. doi: 10.1016/j.gaitpost.2020.10.025. Epub 2020 Oct 23.

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• Abbasi A, Yazdanbakhsh F, Tazji MK, Aghaie Ataabadi P, Svoboda Z, Nazarpour K, Vieira MF. A comparison of coordination and its variability in lower extremity segments during treadmill and overground running at different speeds. Gait Posture. 2020 Jun;79:139-144. doi: 10.1016/j.gaitpost.2020.04.022. Epub 2020 May 1.

  PMID: 32408037 BACKGROUND

• 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.

  PMID: 35080495 RESULT

Related Links

• Functional Gait Assessment. Shirley Ryan Ability Lab
• Dynamic Gait Index. Shirley Ryan Ability Lab
• Berg Balance Scale. Shirley Ryan Ability Lab
• Functional Independence Measure (FIM). Physio-pedia
• Activities Specific Balance Confidence Scale. Shirley Ryan Ability Lab
• Berg Balance Scale. Physio-pedia

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This study was partly conducted during the early months of the COVID-19 pandemic (03/2020-08/2020). As such, this environment may have shortened the time participants were willing to spend in an inpatient setting. As a consequence, 40% of participants, at least once, needed to receive two sessions in the same day to complete all eight sessions due to expedited discharge timelines; in one case, a participant discharged before completing the last treatment session.

Results Point of Contact

• Title: Dr. Henry C. Hrdlicka, Research Coordinator
• Organization: Gaylord Hospital Inc.

hhrdlicka@gaylord.org

203-284-2864

Study Officials

• Amanda Meyer, MS OTR/L

  Gaylord Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants and care providers are unable to be masked to the intervention arm due to the nature of the study. As data was extracted, investigators were unable to blind the data prior to exporting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-randomized controlled pilot study evaluating the efficacy of a recently developed, not yet reported, balance perturbation module for the ZeroG body weight support system known Training Responses in Postural rehabilitation (TRiP).

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: October 3, 2019
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: August 17, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)