Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-04 @ 1:43 PM
Study NCT ID:
NCT07094659
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aging and Task-specific Training to Reduce Falls
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Aging and Task-Specific Training to Reduce Falls
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
Detailed Description:
The proposed study employs a randomized, controlled design to assess the immediate and long-term effects of task-specific balance training for reducing environmental falls in at-risk community-ambulatory older adults. \>33% of older adults fall at least once each year, leading to serious injuries (e.g., hip fractures), comorbidities (e.g., Alzheimer's Disease and related dementias), and higher chances of falling again. Most falls occur due to environmental disturbances which cause a loss of balance while walking (i.e., slips, trips). Our lab has established that overground perturbation training (repeated exposure to unpredicted perturbations) improves balance control in both predictable (i.e., volitional/anticipatory) and unpredictable (i.e., reactive) environments, and reduces real-life falls among older adults. However, overground perturbation training is not suitable for routine clinical application due to its complex design, space, and technology requirements. An alternative method for delivering perturbation training is via commercial treadmill systems, which enhance fall-resisting skills and are more feasible for community-translation. However, treadmill perturbation training still requires costly equipment and has lower translational effectiveness for reducing falls in community-ambulatory older adults than overground training. This may be because treadmill perturbation training mainly trains reactive balance control, while falls may also occur due to deficits in volitional balance control which affect gait stability during daily tasks. Volitional balance training has primarily comprised of conventional balance exercises delivered as a part of physical rehabilitation; however, conventional balance exercises generally do not translate to improvements in reactive balance control when exposed to unpredicted perturbations and have limited effects on reducing real-life falls. A fall prevention intervention that targets both volitional and reactive balance control could more effectively reduce falls in at-risk older adults than existing paradigms which only train a single domain (e.g., reactive-dominant treadmill perturbation training or volitional-dominant conventional balance training). We have developed a novel balance training program that includes both volitional-based task-specific exercises and reactive-based predictable perturbations to target the strategies involved in preventing slip- and trip-falls. This task-specific balance training requires little set-up and equipment, making it cost-effective, feasible and accessible. We will examine the immediate effects of 8 weeks (16 sessions) of task-specific balance training on reactive balance (Aim 1) and volitional balance (Aim 2), compared with established fall prevention paradigms (treadmill perturbation training and conventional balance training). Additionally, we will evaluate the longer-term retention (18 months) of task-specific balance training and effects on real-life falls and falls efficacy (Aim 3). In an exploratory aim, we will also examine the neuromuscular adaptations induced through training using muscle synergy analysis (Aim 4). If successful, our novel intervention could be implemented as a feasible, safe, and effective fall prevention intervention, with large potential for direct dissemination to clinical settings.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R01AG050672-06A1 | NIH | None | https://reporter.nih.gov/quic… | View |