Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke
NCT ID: NCT04919161
Last Updated: 2021-08-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2019-10-03
2020-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multisite Exploration of Balance Perturbations With and Without Body Weight Support
NCT05110300
Walking Balance Training Post-Stroke
NCT06090604
Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
NCT07113041
Gait Perturbations to Improve Balance Post-stroke
NCT04314830
Retraining the Walking Pattern After Stroke
NCT03813342
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
For this study, the BWSS used was the FDA listed ZeroG Gait and Balance System (Aretech, LLC, Ashburn, VA). ZeroG was first introduced to the investigators institution in September 2019. Unlike some BWSSs, this device is mounted on an overhead track that follows users during ambulation. Like other BWSSs, this system is designed to unload the users of up-to 200 pounds of their body weight while simultaneously protecting patients from falling. For this study, 10 pounds of participants' body-weight, the system minimum required to engage the BWSS, was continuously displaced. If a participant were to fall, the system would detect the change, decelerate, and stop the descent after a set distance; the fall distance was set between 8 to 12 inches for the purpose of this study. Unlike other BWSSs, a newly developed balance perturbation module known as the Training Responses in Postural rehabilitation or TRiP, is directly integrated to the ZeroG BWSS. This perturbation module is different than other systems as the balance perturbations are elicited directly through the BWSS and do not require a treadmill, tilt-table/shaking platform, or manual exertion by a. Further, they can be induced during normal gait and balance exercises during therapy. 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. The BWSS with perturbation (BWSS-P) intervention group performed the same activities as the control group, with the addition of lateral, anterior, and posterior perturbations. Assistive devices and equipment were used during intervention sessions as recommended by the participant's primary therapist, including: canes, rolling walkers, hemi-walkers, and ankle-foot-orthoses (AFO), ankle support braces, and upper extremity slings.
Investigators administered perturbations using a Wi-Fi-enabled handheld device linked to the BWSS and these consisted of a sudden and brief assistive or resistive force in the desired direction. Lateral perturbations were issued while participants were in a static stance, while anterior and posterior perturbations were issued during ambulation; eight perturbations, two in each direction, were completed each session. All participants started at perturbation level "one" and progressed up to a maximum perturbation level of "ten" through the course of the study. The amount of force exerted at each perturbation level is pre-set by the manufacturer. The perturbation level (i.e. intensity or force) used each session was based on the participant's progress and observational analysis made by the investigator of the participants' response to the perturbation level. If the participant was able to tolerate the initial perturbation level without exhibiting a balance reaction, the perturbation level was incrementally increased until an appropriate balance reaction was exhibited. If a participant was unable to recover and elicited a fall response in the system, the perturbation level was decreased by one level to ensure patient safety, and the exercise repeated to reinforce the exercise mechanics and participant confidence.
Participants in both study groups received a total of eight treatment sessions over two weeks. As necessary, participants received up to two sessions in one day to ensure they completed the required eight sessions before discharge. These sessions were incorporated into the participants' regular care. Treatment sessions were broken into 30 minute blocks as it standard at the host facility. This time includes participant transportation, equipment set-up, and in the case of this study, donning the BWSS harness. On average, participants received 20 minutes of active time in the BWSS for each 30 minute treatment block. All sessions were analyzed equally despite the length of time in the BWSS.
Missing data:
When outcome measurements are missing due to early participant withdrawal, if the participant completed 50% or less of the study sessions, that participant's data was removed. If the participant completed greater than 50%, then that participant's data was analyzed as normal.
Data Analysis:
Data was analyzed using GraphPad Prism version 9.0.0 (GraphPad Software, San Diego, CA). To compare the observed proportion of males and females in the BWSS groups, a Binomial Test and Fisher's exact test were used. The 95% confidence intervals reported the proportion of males and females in the BWSS-P group were calculated using the Wilson-Brown Method. Berg Balance Scale (BBS) and Activities specific Balance Confidence measurement changes between the pre- and post-intervention were compared directly, as well as between groups. The degree of change made by each individual was shown by calculating the percent change: \[((Post assessment) - (Pre assessment)) / (Pre assessment)\] ×100% .
BBS data of stroke rehabilitation patients from fiscal year 2018 served as a historical standard of care (SOC) baseline control. The SOC data was sorted to consist of patients with initial BBS scores of 21 or greater and who were admitted and discharged before the launch of the institution's BWSS in September 2018. This resulted in the inclusion of retrospective BBS data from 30 patients. Shapiro-Wilk testing was first used to test for normality; if one or more of the data-sets in the group failed (p\<0.05), nonparametric tests were used going forward. For hypothesis testing between two groups, unpaired or paired two-tailed Student's t-test were conducted as appropriate. When indicated by an F-test for variance (p\<0.05), Welch's correction was applied for unequal standard deviations between groups. When comparing three or more groups, if one or more groups were abnormally distributed, non-parametric Kruskal-Wallis analysis of variation (ANOVA) test and Dunn's multiple comparison test for statistical hypothesis testing were used. When normally distributed, an Ordinary one-way ANOVA with a Tukey's multiple comparisons test for statistical hypothesis testing was used. If Brown-Forsythe's test for variance indicated the variance of the groups were significantly different (p\<0.05), a Brown-Forsythe correction was applied and Dunnett's T3 multiple comparisons test for statistical hypothesis testing was used instead.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Body weight support system control group
In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.
Body weight support system control group
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.
Body weight support system with balance perturbations
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.
Body weight support system with balance perturbations
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.
Historical Standard of Care control
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Body weight support system control group
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.
Body weight support system with balance perturbations
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gaylord Hospital, Inc
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amanda Meyer, MS OTR/L
Role: PRINCIPAL_INVESTIGATOR
Gaylord Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gaylord Hospital
Wallingford, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Chen N, Xiao X, Hu H, Chen Y, Song R, Li L. Identify the Alteration of Balance Control and Risk of Falling in Stroke Survivors During Obstacle Crossing Based on Kinematic Analysis. Front Neurol. 2019 Jul 30;10:813. doi: 10.3389/fneur.2019.00813. eCollection 2019.
Forster A, Young J. Incidence and consequences of falls due to stroke: a systematic inquiry. BMJ. 1995 Jul 8;311(6997):83-6. doi: 10.1136/bmj.311.6997.83.
Legters K. Fear of falling. Phys Ther. 2002 Mar;82(3):264-72. No abstract available.
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.
Hidler J, Hamm LF, Lichy A, Groah SL. Automating activity-based interventions: the role of robotics. J Rehabil Res Dev. 2008;45(2):337-44. doi: 10.1682/jrrd.2007.01.0020.
Hidler J, Lum PS. The road ahead for rehabilitation robotics. J Rehabil Res Dev. 2011;48(4):vii-x. doi: 10.1682/jrrd.2011.02.0014. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Functional Gait Assessment. Shirley Ryan Ability Lab
Dynamic Gait Index. Shirley Ryan Ability Lab
Berg Balance Scale. Shirley Ryan Ability Lab
Activities Specific Balance Confidence Scale. Shirley Ryan Ability Lab
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201901Ber
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.