Reactive Balance Training for Fall Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: Treadmill training
Other interventionParticipants 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
Other interventionSlips 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
Other interventionDuring 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Treadmill trainingExperimental treatment 1 intervention
Group B: Overground trainingExperimental treatment 1 intervention
Group C: Surefooted trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (1st novel slip, week 1) and at Immediate post-training (after repeated perturbation training session, week 1)2
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.
Time frame
Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1)3
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.
Time frame
Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1)4
Number of Real life falls
Real life falls are measured to determine if training effect can be translated into everyday real life setting.
Time frame
prospective post-training over next 12 months (total falls tracked and reported at 12 months post-training will be compared between groups)Secondary outcomes
1
Center of mass excursion angle
the deviation of the Center of mass relative to the sagittal plane
Time frame
Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 12
Medio-Lateral excursion of center of mass
The peak excursion of the COM perpendicular to the walking direction
Time frame
Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 13
Change in Number of steps
The total number of steps and distance for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in physical activity of the patient and decrease reliance on the assistive device.
Time frame
One month before pretest till prospectively 12 months post trainingSponsors and contacts
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Source ClinicalTrials.gov