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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05110300
Recruitment Status : Enrolling by invitation
First Posted : November 5, 2021
Last Update Posted : March 28, 2022
Sponsor:
Collaborators:
Medstar Health Research Institute
St. Luke's Rehabilitation Institute
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Gaylord Hospital, Inc

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.

Condition or disease Intervention/treatment Phase
Stroke Stroke, Acute Balance; Distorted Balance; Impairment Gait, Unsteady Device: Body weight support system control group Device: Body weight support system with balance perturbations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a multisite, randomized, active-comparator controlled clinical trial.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Study of a Novel, Body-weight Supported, Balance-perturbation Module During the Rehabilitation of Gait and Balance Impairments Secondary to Stroke: A Multisite Randomized Control Trial
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Body weight support system control group
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
Participants will complete the physical therapy exercises as described previously, without experiencing, therapist induced, balance perturbations.
Other Names:
  • ZeroG
  • BWSS
  • BWSS control
  • Zero G

Experimental: Body weight support system with balance perturbations
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
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,
Other Names:
  • ZeroG with training response in postural rehabilitation
  • ZeroG - TriP
  • ZeroG TriP
  • BWSS-P
  • BWSS+P
  • Zero G TRiP
  • Zero G - TRiP
  • TRiP




Primary Outcome Measures :
  1. Berg Balance Scale Pre-intervention Assessment Scores [ Time Frame: The pre-assessment Berg Balance Scale score will be collected during the initial physical therapy assessment within 72 hours of admission, as part of their normal care. ]
    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.

  2. Berg Balance Scale Post-intervention Assessment Scores [ Time Frame: The post-assessment Berg Balance Scale score will be collected within 48 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.

  3. Activities Specific Balance Scale (ABC) Pre-intervention Scores [ Time Frame: The pre-assessment patient reported Activities Specific Balance Scale will be collected during the informed consent process. ]
    The ABC scale is a 16-item patient reported outcome measure that subjectively measures ones self-perceived balance-confidence. The ABC achieves this by asking the user to consider various hypothetical situations and tasks and if the participants could perform the 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).

  4. Activities Specific Balance Scale (ABC) Post-intervention Scores [ Time Frame: The post-assessment patient reported Activities Specific Balance Scale will be collected immediately following the last study session. ]
    The ABC scale is a 16-item patient reported outcome measure that subjectively measures ones self-perceived balance-confidence. The ABC achieves this by asking the user to consider various hypothetical situations and tasks and if the participants could perform the 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).

  5. 10 Meter Walk Test (10MWT) Pre-intervention Scores [ Time Frame: The pre-assessment 10MWT will be conducted by site investigators within 48 hours prior to the first study session. ]
    The 10MWT is used to assess walking speed in meters/second (m/s) over 10 meters (m). The time is started when any part of the leading foot crosses the plane of the 2 m mark. Time is stopped when any part of the leading foot crosses the plane of the 8 m mark. The total time taken to ambulate the central 6 m is recorded to the nearest hundredth of a second. 6 m is then divided by the total time and recorded in m/s (the faster the participant traverses 6 meters the better).

  6. 10 Meter Walk Test (10MWT) Post-intervention Scores [ Time Frame: The post-assessment 10MWT will be collected within 48 hours of the last study session. ]
    The 10MWT is used to assess walking speed in meters/second (m/s) over 10 meters (m). The time is started when any part of the leading foot crosses the plane of the 2 m mark. Time is stopped when any part of the leading foot crosses the plane of the 8 m mark. The total time taken to ambulate the central 6 m is recorded to the nearest hundredth of a second. 6 m is then divided by the total time and recorded in m/s (the faster the participant traverses 6 meters the better).


Secondary Outcome Measures :
  1. Continuity Assessment Record and Evaluation (CARE) Tool Mobility Admission Scores [ Time Frame: The CARE tool will be administered within 72 hours of participant admission. ]
    The CARE Item Set measures the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set is designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings, including long-term care hospitals (LTACHs). The Mobility Score consists of 9 questions scored on scale of 1 to 6 scale. The scale ranges from 1 (dependent) to 6 (independent). The higher the overall score, the better.

  2. Continuity Assessment Record and Evaluation (CARE) Tool Mobility Discharge Scores [ Time Frame: The CARE tool will be administered within 48 hours before discharge. ]
    The CARE Item Set measures the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set is designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings, including long-term care hospitals (LTACHs). The Mobility Score consists of 9 questions scored on scale of 1 to 6 scale. The scale ranges from 1 (dependent) to 6 (independent). The higher the overall score, the better.

  3. Continuity Assessment Record and Evaluation (CARE) Self-Care Admission Scores [ Time Frame: The CARE tool will be administered within 72 hours of participant admission. ]
    The CARE Item Set measures the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set is designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings, including long-term care hospitals (LTACHs). The Self-Care Score consists of 6 questions scored on scale of 1 to 6 scale. The scale ranges from 1 (dependent) to to 6 (independent). The higher the overall score, the better.

  4. Continuity Assessment Record and Evaluation (CARE) Self-Care Discharge Scores [ Time Frame: The CARE tool will be administered within 48 hours before discharge. ]
    The CARE Item Set measures the health and functional status of Medicare beneficiaries at acute discharge, and measures changes in severity and other outcomes for Medicare post-acute care patients. The CARE Item Set is designed to standardize assessment of patients' medical, functional, cognitive, and social support status across acute and post-acute settings, including long-term care hospitals (LTACHs). The Self-Care Score consists of 6 questions scored on scale of 1 to 6 scale. The scale ranges from 1 (dependent) to to 6 (independent). The higher the overall score, the better.

  5. Perturbation Level Progression [ Time Frame: The highest perturbation level achieved by the participant achieved will be recorded immediately after each intervention session. ]
    All participants will start at perturbation level "one" and progress 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. In total, 2 to 6 readings will be collected for each BWSS-P participant for the 2 to 6 intervention sessions completed for the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patients requiring more than 50% high flow oxygen as consistent with inpatient therapy guidelines
  • Anyone belonging to a vulnerable population, including inmates, individuals under the age of 18, and who are or might be pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05110300


Locations
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United States, Connecticut
Gaylord Hospital
Wallingford, Connecticut, United States, 06492
United States, District of Columbia
MedStar National Rehabilitation Hospital
Washington, District of Columbia, United States, 20010
United States, Massachusetts
Spaulding Rehabilitation Hospital
Sandwich, Massachusetts, United States, 02537
United States, Washington
Providence St. Luke's Rehabilitation Medical Center
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Gaylord Hospital, Inc
Medstar Health Research Institute
St. Luke's Rehabilitation Institute
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Pete Grevelding, MSPT Gaylord Hospital, Inc
Additional Information:
Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Gaylord Hospital, Inc
ClinicalTrials.gov Identifier: NCT05110300    
Other Study ID Numbers: 202108GRE
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Copies of the study protocol will be provided upon request. Requests for copies of the de-identified research data will be considered on a situational basis after the final analysis has been completed. To make such a request please contact Dr. Henry C Hrdlicka (hhrdlicka@gaylord.org).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gaylord Hospital, Inc:
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
Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Body Weight
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents