Aging and Mixed Perturbation Training to Reduce Falls in Locomotion
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|ClinicalTrials.gov Identifier: NCT03199729|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Older Adults||Other: Slip-only training Other: Trip-only training Other: Combined slip+trip training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Controlled design to understand the mechanisms of adaptive interference and generalization, their interaction with retention, and how these can be applied to maximize training effects for minimizing falls-risk among older adults.|
|Masking:||None (Open Label)|
|Official Title:||Aging and Mixed Perturbation Training to Reduce Falls in Locomotion|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Slip-only training
Overground, slip specific perturbation training only delivered in a fixed sequence. After the baseline walking trials, subjects will walk for 30-35 trials, after which training will begin consisting of a first block of 8 repeated slips (S1-S8), a block of 3 regular (non-perturbed) walking trials (W1-W3), another block of 8 slips (S9-16), a second block of 3 regular walking trials (W4-W6), and a final block of 8 slips (S17-S24) mixed with 10 regular walking trials.
Other: Slip-only training
Subjects in this arm will receive overground, slip specific perturbation training only. The total perturbation training trials received by this group will be 24 but the protocol will consist of a total of 70-75 trials (to match the training length and time of Combined slip and trip training group).
Experimental: Trip-only training
Trip specific training delivered in an identical sequence (mixed with non-trip trials) as the Group with slip only training.
Other: Trip-only training
Subjects in this arm consisting of a total of 24 trials of trip specific training delivered in an identical sequence (mixed with non-trip trials) as the Group with slip only training.
No Intervention: Control
Walk for about 70-75 trials at the preferred walking pace to match the total trials the other groups receive before the test perturbations.
Experimental: Combined slip+trip training
Training consisting of repeated exposure to both slips and trips.
Other: Combined slip+trip training
Subjects in this arm will receive training consisting of repeated exposure to both slips and trips with a total of 24 slips plus 24 trips to keep the number of trials of each perturbation same as the perturbation specific training groups (slip only and trip only), however, the total dose will be doubled. The total trials walked (perturbed + unperturbed) will be 75.
- Change in laboratory-induced falls [ Time Frame: Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1 ) and at 12-month re-test (to determine long-term retention of training). ]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 12 months after the initial training session.
- 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) ]Real life falls are measured to determine if training effect can be translated into everyday real life setting.
- Stability gain (or loss) [ Time Frame: Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1) and at 12-month re-test (to determine long-term retention of training). ]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.
- Limb support gain (or loss) [ Time Frame: Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1) and at 12-month re-test (to determine long-term retention of training). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199729
|Contact: Shamali Dusane, MPTemail@example.com|
|Contact: Yiru Wang, MS PTfirstname.lastname@example.org|
|Principal Investigator:||Tanvi Bhatt, PhD PT||University of Illinois at Chicago|