Reactive Balance Training for Fall Prevention

NCT04205279 | Recruiting

• 1 other identifier: 2017-1069
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to evaluate and compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults, and neurologically impaired stroke individuals. Furthermore, the project aims to determine the feasibility and tolerability of 30-minutes of perturbation training using the SureFooted Trainer. Overall, the project directs to find out the long term effect of training on fall risk reduction and fall prevention. This study investigates the effects of perturbation training (slip and trip) based on the principles of motor learning. Perturbations in the form of slips and trips induced by the three different types of perturbation devices will displace the center of mass outside the base of support and challenge the stability, thereby inducing a fall and demand compensatory strategies in order to prevent it. Such perturbation training would train the motor system to improve stability control and vertical limb support. The project design aims to examine the ability of the central nervous system to mitigate the interference in stability control (if any) that is induced by opposing types of perturbations. The hypothesis of this study if supported by the results, will provide the difference in motor learning with training on three different perturbation devices. Furthermore, it would help to determine which of the three training devices is the most effective in developing defense mechanisms necessary to reduce fall-risk among community-living older adults and the neurological population.

Conditions

Healthy Young; Healthy Aging; Stroke

Keywords

Reactive balance; Virtual reality training; Surefooted platform

Outcome Measures

Primary Outcomes (4)

• Change in Stability gain or loss

  Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity.

  Baseline (1st novel slip, week 1) and at Immediate post-training (after repeated perturbation training session, week 1)

• Change in Limb support gain or loss

  The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall.

  Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1)

• Change in laboratory-induced falls

  Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by the amount of body weight supported by the full-body harness system and measured by a load cell attached to this system. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90\~100% of subsequent falls (occurring \~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings. Intervention consists of repeated perturbation training to induce a change in the laboratory induced falls immediately post-training and examine it's retention after the initial training session.

  Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1)

• Number of Real life falls

  Real life falls are measured to determine if training effect can be translated into everyday real life setting.

  prospective post-training over next 12 months (total falls tracked and reported at 12 months post-training will be compared between groups)

Secondary Outcomes (3)

• Center of mass excursion angle

  Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 1

• Medio-Lateral excursion of center of mass

  Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 1

• Change in Number of steps

  One month before pretest till prospectively 12 months post training

Study Arms (3)

Treadmill training

EXPERIMENTAL

Subjects randomly assigned to the treadmill training, would undergo either a stance or walking perturbation training protocol. The stroke subjects and older adults would be assigned to either the stance or walking perturbation training protocol. All the participants would be asked to perform voluntary stepping, backward and forward with both limbs pre and post perturbation training. Also, all the participants would perform walking trials with head mounted virtual reality system under three conditions: ice, beach and crowd.

Other: Experimental: Treadmill training

Overground training

EXPERIMENTAL

Subjects randomly assigned to overground slip will be made to walk at their comfortable natural walking speeds either for 5-8 trials on the instrumented walkway (7 m 1.5 m) at their self-selected preferred speed. All the participants would perform walking trials with head mounted virtual reality system under three conditions: ice, beach and crowd. After establishing baseline walking ability, a slip will be introduced without warning which will comprise the baseline slip test followed by a trip in the form of the trip plate. This is followed by a block of 8 trials for slip training, block of 8 trials for trip training and then the mixed block consisting of slip and trip trials interspersed with walking trials. Slips and trips could be induced under either of the limbs.

Other: Experimental: Overground training

Surefooted training

EXPERIMENTAL

Subjects randomly assigned to Surefooted (Surefooted LLC) would be donned a safety harness and instructed that "when you experience slip-like or trip-like movements, try to keep walking on the platform". Subjects would undergo 4-minute training block on each of the 6 different conditions. The first 3 training blocks would be unidirectional perturbation (either slip or trip) followed by 3 training blocks of mixed directional perturbations while the subjects are walking on the platform. 3 surface conditions- slippery (vinyl surface plate), normal friction with obstacles (surface plate with 6" tall structures embedded), and a foam surface with obstacles embedded would be used.

Other: Experimental: Surefooted training

Interventions

Experimental: Treadmill training OTHER

Participants will be given thirteen slips and thirteen trips in stance and walking, followed by two slips and two trips at a higher intensity (posttest). Subjects would be consented if they would like to undergo fMRI pre and post-training. Participants not willing to undergo imaging would not be excluded. Three day training consisting of blocks of five consecutive gait-slips at varying intensities will be provided. Individuals with stroke would undergo an additional session (total 4 training sessions over 4 weeks (1session/week) since these individuals get easily fatigued and also might need more training sessions with sufficient rest interval to induce reactive adaptation. Training at a specific level will persist until the subjects show a recovery step response in at least 3/5 trials in a single block. Once subjects successfully adapt to this level, the perturbation intensity will be increased until they show a recovery response in at least 3/5 trials.

Treadmill training

Experimental: Overground training OTHER

Slips and trips could be induced under either of the limbs. The specialized walkway consists of two sliding platforms, each of which is mounted on two rows of low friction linear bearings (friction coefficient = 0.02). The base plate of each platform is bolted separately onto the top of a force platform embedded in the floor. An electronic-mechanical latch system is used to control the 2 states of the support platform; that is, the "locked" state for regular walking and the "release" state to initiate slipping are carefully controlled. The sliding top of the platform is released after the heel strike (vertical force to exceed 2% of the body weight). The slip distance would be adjusted between 30 to 60 centimeters depending upon the different population and their physical capacity.

Overground training

Experimental: Surefooted training OTHER

During the first minute of each block, subjects would experience no perturbations followed by 3 minutes of single or multi-directional perturbations. A one minute break between each condition would be provided. Subject's fatigue would be assessed by Fatigue severity scale to determine the tolerability of 30 minute training protocol. The expected duration to complete the test would be a maximum of 1 hour including the preparation and training time.

Surefooted training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Young participants
• Age group: 18-55 years.
• Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal or systemic diagnosis.
• No recent major surgery (\< 6 months) or hospitalization (\< 3 months)
• Not on any sedative drugs.
• Can understand and communicate in English
• Healthy older adults
• Age group: 56-90 years.
• Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal or systemic diagnosis.
• No recent major surgery (\< 6 months) or hospitalization (\< 3 months)
• Not on any sedative drugs.
• Ability to walk with or without an assistive device for 10 meters
• Can understand and communicate in English
• Berg balance scale score \<45/56.
• Persons with stroke

You may not qualify if:

• Healthy subject:
• Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting \< 95%.
• Body weight more than 250 lbs.
• Healthy Older adults:
• Individuals with heel bone density with a T-score \< -2, is classified as osteoporotic and will be excluded.
• Individuals with mild cognitive impairment (Mini-mental State Exam score \< 25/30) will be excluded.
• Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting \< 95%.
• minute walk test. Subjects will also be screened out if on the 6 minute walk test they complain of shortness of breath or uncontrolled pain (\> 3/10 on VAS) or pulse oxygen drops \< 92% or are unable to achieve the age-specified minimal ambulation distance.
• Body weight more than 250 lbs.
• Persons with stroke:
• Individuals with heel bone density with a T-score \< -2, is classified as osteoporotic and will be excluded.
• Individuals with mild cognitive impairment (Mini-mental State Exam score \< 25/30) will be excluded.
• Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting \< 95%.
• minute walk test. Subjects will also be screened out if on the 6 minute walk test they complain of shortness of breath or uncontrolled pain (\> 3/10 on VAS) or pulse oxygen drops \< 92% or are unable to achieve the age-specified minimal ambulation distance.
• Body weight more than 250 lbs.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Tanvi Bhatt, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamali Dusane, MPT

CONTACT

3123552735; sdusan2@uic.edu

Lakshmi Kannan, MS PT

CONTACT

3124133175; lkanna2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Controlled design to compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults and person with stroke.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 19, 2019
• Study Start: February 1, 2018
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)