StrokeNCT04919161
Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke
A study testing Body weight support system with balance perturbations in people with Stroke and Balance; Distorted, run by Gaylord Hospital, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Balance; Distorted
- What is being tested?
- Body weight support system with balance perturbations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admission Berg Balance Scale score of 21 or greater
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unblinded Quasi-Randomized Pilot Study Exploring the Benefits of the ZeroG TRiP System to Improve Patient Balance Following an Acute Stroke
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.
Read the detailed description
Body-Weight Support System Equipment and Interventions:
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
- Stroke, Balance; Distorted
- Being tested
- Body weight support system control group, Body weight support system with balance perturbations
- 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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body weight support system control groupDevice
Also called ZeroG; BWSS; BWSS control
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 perturbationsDevice
Also called ZeroG with training response in postural rehabilitation; BWSS-P; BWSS+P
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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%
Measured: 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.
Measured: 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
During their regular treatment, a modified functional independence measure, based on a scale of 0 (completely dependent) to 10 (completely independent), was used to assess each participant's assistance needs while undergoing toilet transfers. These scores were collected during a chart review conducted within 48 hours after participant discharge.
Measured: 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
During their regular treatment, a modified functional independence measure, based on a scale of 0 (completely dependent) to 10 (completely independent), was used to assess each participant's assistance needs while ambulating. These scores were collected during a chart review conducted within 48 hours after participant discharge.
Measured: 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
All participants started at perturbation level "one" and progressed up to a maximum perturbation level of "ten" through the course of the study; the higher the level,the more intense the exerted force. The amount of force exerted at each perturbation level is pre-set by the manufacturer.The highest perturbation level achieved by the participant achieved was recorded immediately after each intervention session. In total, 8 readings were collected for each BWSS-P participant for the 8 intervention sessions completed for the study.
Measured: Perturbation level recordings completed for each of the 8 sessions completed over an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start3 Oct 2019
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaylord Hospital, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Meyer, MS OTR/L, Principal investigator, Gaylord Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919161
- Sponsor's protocol ID
- 201901Ber
- Status last verified
- Jul 2021
- First submitted
- 27 May 2021
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Copies of the study protocol will be provided upon request. Requests for copies of deidentified study data will considered on a case by case basis
Publications
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.
PubMed 28122885Alguren 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.
PubMed 20136473Chen 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.
PubMed 31417488Forster 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.
PubMed 7613406Legters K. Fear of falling. Phys Ther. 2002 Mar;82(3):264-72. No abstract available.
PubMed 11869155Landers 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.
PubMed 26294679Hidler 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.
PubMed 18566951Hidler 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.
PubMed 21674383Chien 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.
PubMed 30467355Shimada 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.
PubMed 15213472Esmaeili 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.
PubMed 32552850Steib 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.
PubMed 28758519Schinkel-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.
PubMed 30630753Mansfield 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.
PubMed 30121600Hidler 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.
PubMed 21674384
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unblinded Quasi-Randomized Pilot Study Exploring the Benefits of the ZeroG TRiP System to Improve Patient Balance Following an Acute Stroke
- ClinicalTrials.gov ID
- NCT04919161
- Acronym / sponsor ID
- 201901Ber
- Conditions
- Stroke, Balance; Distorted
- Keywords
- Stroke Rehabilitation, Postural Balance, Gait and Ambulation, Balance Perturbation, Postural Perturbation, Body Weight Support System, Occupational Therapy, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gaylord Hospital, IncUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Posted 17 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Body-Weight Support System Equipment and Interventions:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Body weight support system control group | Active comparator | Device: Body weight support system control groupIn this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system. |
| Body weight support system with balance perturbations | Experimental | Device: Body weight support system with balance perturbationsSimilar 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission Berg Balance Scale score of 21 or greater
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body weight support system control groupAlso: ZeroG; BWSS; BWSS controlThe 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. | Device | Body weight support system control group |
| Body weight support system with balance perturbationsAlso: ZeroG with training response in postural rehabilitation; BWSS-P; BWSS+PThe 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. | Device | Body weight support system with balance perturbations |
Primary outcome
Difference in Berg Balance Scale Pre-intervention and Post-intervention Assessment Scores
Time frame: 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.
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)
Comparison of Berg Balance Scale Assessment Score Changes
Time frame: 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.
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
Differences in the Percent Change of Berg Balance Scale (BBS) Assessment Scores
Time frame: 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.
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%
Activities-Specific Balance Confidence (ABC) Scale Score Change
Time frame: The pre-assessment ABC is completed at participant enrollment just prior to first intervention. The post-assessment ABC is completed immediately after final intervention.
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.
3 secondary outcomes
Toilet Transfer Score
Time frame: 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
Time frame: 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
Time frame: Perturbation level recordings completed for each of the 8 sessions completed over an average of 2 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28122885Benjamin 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.
- Background: PubMed 20136473Alguren 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.
- Background: PubMed 31417488Chen 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.
- Background: PubMed 7613406Forster 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.
- Background: PubMed 11869155Legters K. Fear of falling. Phys Ther. 2002 Mar;82(3):264-72. No abstract available.
- Background: PubMed 26294679Landers 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.
- Background: PubMed 18566951Hidler 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.
- Background: PubMed 21674383Hidler 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.
- Background: PubMed 30467355Chien 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.
- Background: PubMed 15213472Shimada 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.
- Background: PubMed 32552850Esmaeili 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.
- Background: PubMed 28758519Steib 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.
- Functional Gait Assessment. Shirley Ryan Ability LabLink provided by the sponsor.
- Dynamic Gait Index. Shirley Ryan Ability LabLink provided by the sponsor.
- Berg Balance Scale. Shirley Ryan Ability LabLink provided by the sponsor.
- Activities Specific Balance Confidence Scale. Shirley Ryan Ability LabLink provided by the sponsor.
- Berg Balance Scale. Physio-pediaLink provided by the sponsor.
- Stroke Facts. Centers for Disease ControlLink provided by the sponsor.
- Individual participant dataSharing planned: No. Copies of the study protocol will be provided upon request. Requests for copies of deidentified study data will considered on a case by case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Meyer, MS OTR/L principal investigator
Gaylord Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body weight support system with balance perturbations in people with Stroke and Balance; Distorted, run by Gaylord Hospital, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Berg Balance Scale Pre-intervention and Post-intervention Assessment Scores (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919161, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.