Aging and Task-specific Training to Reduce Falls
ConditionFall Prevention
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60-90
SponsorUniversity of Illinois at Chicago
About this trial
The goal of this clinical trial is to examine the effects of a novel task-specific balance training for reducing environmental falls in community ambulatory older adults who are at-risk of falling. The main questions it aims to answer are:
* Does task-specific balance training improve the ability to prevent falling when unexpected perturbations such as slips and trips occur, and/or improve balance control during self-initiated movements? * Does task-specific balance training reduce real-life falls for 18 months after training?
Researchers will compare task-specific balance training with conventional balance training and treadmill perturbation-based training to examine how this novel intervention compares to established interventions for improving balance.
Participants who participate in the study will be asked to do the following:
* Complete a pre-training assessment of their balance control, and then be randomized to one of three training groups: 1) task-specific balance training, 2) treadmill perturbation-based training, and 3) conventional balance training * Complete their assigned training protocol for 8 weeks (2x per week for a total of 16 sessions) * Complete 2 post-training assessments of their balance control, the first being completed immediately after the training is completed, and the second being completed 18 months after the training is completed * Wear a physical activity monitor for 18 months after completing the intervention to monitor their real life falls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
60 to 90 years of age to include community dwelling older adults
Understand English to ensure ability to safely complete study protocols
Able to walk independently for 1 block and 10 meters without an assistive device to ensure ability to complete exercises and reactive balance assessments
'At-risk' adults: Participants who report experience of at least 1 fall in the past 12 months or participants who are categorized as at high fall- risk using our fall risk prediction model which can predict the risk of both slip and trip related falls.
Disqualifiers
Major surgery less than 6 months ago to avoid complications due to training
Hospitalization less than 3 months ago to avoid complications due to training
Taking any sedative drugs to avoid interference with training
Acute or uncontrolled neurological or cardiopulmonary or musculoskeletal or cancer diagnosis to avoid complications due to training
Trial design
Design model
Parallel
Treatments tested in this trial
Task-Specific Balance Training
BehavioralParticipants in the intervention groups will receive 8 weeks of task-specific balance training that includes both functional tasks and predictable perturbations specific to slips and trips. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
Treadmill Perturbation Training
BehavioralParticipants in the treadmill perturbation training group will receive 8 weeks of training that includes exposure to slip-like and trip-like perturbations delivered via motorized treadmill. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
Conventional Balance Training
BehavioralParticipants in the conventional balance training group will receive 8 weeks of training that includes conventional exercises designed to improve balance control. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
Treatment groups
315 Participants
are divided into 3 treatment groupsGroup A: Task-Specific Balance TrainingExperimental treatment 1 intervention
Group B: Treadmill Perturbation TrainingActive comparator 1 intervention
Group C: Conventional Balance TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reactive Stability
Center of mass position will be computed via Helen Hayes marker set using an eight-camera motion capture system and normalized by foot length. The center of mass velocity will be computed by the first order derivative of the center of mass position and normalized to acceleration due to gravity and participant's body height. Reactive stability will be calculated as the shortest perpendicular distance from the center of mass state (position and velocity) to the dynamic feasible theoretical boundary for loss of balance. Reactive stability values less than 0 indicate greater instability in the backward direction, while values greater than 1 indicate greater instability in the forward direction.
Time frame
Immediately post and at 18 months2
Vertical Limb support
Limb support will be quantified by change in vertical limb support upon the perturbation hip height. The hip height, Zhip, will be obtained as the vertical distance of the bilateral hip midpoint to the surface of the platform. Its positive direction is upward. Zhip will be normalized to bh. Change in Zhip at recovery foot touchdown and its minimum value post-perturbation from its pre-perturbation value will be extracted.
Time frame
Immediately post and at 18 months3
Laboratory falls
Falls on laboratory perturbation will be identified when the peak load cell force, which is attached to the full-body safety harness exceeds 30% of participant body weight. This will further be verified by video recordings.
Time frame
Immediately post and at 18 months4
Functional Gait Assessment
The functional gait assessment assesses dynamic postural stability and the ability to perform multiple motor tasks during walking, including 10 items where the researcher rates the participant's ability (from 0-3) to perform 10 different gait tasks, such as walking with the eyes closed, walking up stairs, and walking with changes in gait speed. We selected the FGA to determine training-induced improvements in volitional balance control as it highly mimics scenarios which might be encountered during ambulation in daily living.
Time frame
Baseline, Immediately post and at 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov