Recruiting

Reactive Balance Training

Sponsor:

University of Illinois at Chicago

Code:

NCT04205279

Conditions

Healthy Young

Healthy Aging

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Experimental: Treadmill training

Experimental: Overground training

Experimental: Surefooted training

Study Details

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

Study ID

NCT04205279

Start date

Feb 1, 2018

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

  • Age group: 18-90 years.
  • Absence of any acute or chronic neurological diagnosis except stroke (self reported)
  • Onset of stroke (> 6 months)
  • Absence of any 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

Exclusion Criteria:

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%.
  • 6 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%.
  • 6 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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treadmill training

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.

experimental: Overground training

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.

experimental: Surefooted training

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.

Interventions

Experimental: Treadmill training

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.

Experimental: Overground training

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.

Experimental: Surefooted training

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.

Primary outcome measure

  • Change in Stability gain or loss [ Time Frame: 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 [ Time Frame: Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1) ]
  • Change in laboratory-induced falls [ Time Frame: Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1) ]
  • Number of Real life falls [ Time Frame: prospective post-training over next 12 months (total falls tracked and reported at 12 months post-training will be compared between groups) ]

Central Contacts and Locations

Central contacts

Shamali Dusane, MPT

3123552735sdusan2@uic.edu

Lakshmi Kannan, MS PT

3124133175lkanna2@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Tanvi S Bhatt, PhD

3123554443tbhatt6@uic.edu

Lakshmi Kannan, MS

3124133175lkanna2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Reactive balance
  • Virtual reality training
  • Surefooted platform

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-06.