A Balanced Reach Training Platform to Address Balance Disorders in Older and Neurologically Disabled Veterans : A Balanced Reach Training Platform to Address Balance Disorders in Older and Neurologically Disabled Veterans

Overview: This study comprises three Specific Aims (SAs): SA-1) Development of the Balanced Reach Training Protocol (BRTP). SA-2) Assessment of the BRTP's training efficacy. SA-3) Assessment of the BRTP's time course of motor learning.Methods Related to Specific Aim 1: Development of the BRTP SA-1.1: Develop of the BRTP's Assessment Module. The investigators will develop a BRTP such that each foot's position and its associated vertical ground reaction force (used to detect stepping), as measured by the investigators' extant measurement systems, are continuously streamed to a Real Time Computing Workstation and read by the experimental control program, enabling it to monitor these quantities on an ongoing basis. The investigators will next incorporate an adaptive staircase algorithm into the real time experimental control program, that will establish target disk position corresponding to the subject's Limit of Balance (LoB), based on stepping. The investigators will establish LoB corresponding to seven target disk motion directions, each corresponding to a particular direction of Center of Mass (CoM) Motion . Target motion will be programmed to move unpredictably within a small circular region with center r and centerline coinciding with one of the specified directional lines. The subject then tracks the target using their dominant hand index finger. The adaptive staircase algorithm in-rementally increases r, causing the target to move away from the subject until the subject (wearing a harness to guard against falling) must step to avoid a loss of balance, at which point r is reduced by some increment and the process is repeated. During this task the subject will be instructed to step rather than curtail their tracking movements when they believe they are at risk of falling. The degree to which r is increased and decreased depends upon the subject's prior stepping responses and is determined by the adaptive staircase algorithm. As this process continues the algorithm develops a maximum likelihood estimate of the value of r that invokes stepping. When this estimate falls within the desired confidence interval (here 95%) the process terminates; and LoB is computed from the associated force plate and body segment position measurements. Disk displacement along the seven directions will be presented to the subject in random order.The seven values of r determined by the adaptive staircase algorithm will then be reduced by 5% and an ellipse fitted to them. The disk will be programmed to move unpredictably for 90 sec according to the same sum-of-sines function used previously, within a band centered on this ellipse; and subjects will track it. This trajectory will keep subjects at or near their LoB (and at the limits of their balance capability) throughout the tracking task. Establishing LoB in this way eliminates the subjectivity inherent in extant clinical measures of LoB, and also accounts for subjects' aforementioned uncertainty in correctly perceiving their State of Balance and Limit of Balance. The investigators believe that this approach also more accurately simulates the real-life conditions under which people fall, and that LoB will be a better measure of individuals' actual balance capabilities. Furthermore, it makes available a number of other psychophysical measures and functions with which to better understand and describe the role the perceptual and sensory processes play in determining out-of-balance conditions.The Assessment Module will record the following data to characterize performance in the tracking taskThe values of r, , and LoB corresponding to each (Figs. 7A and 1);The motion (position vs. time) of the target disk;The motion of each of 15 body segments (Table 1), and the tip of the tracking finger (measured by the investigators' Vicon Motion Capture System);Ground reaction forces, moments, and CoP for each foot and for both feet combined (dual Bertec force plates); Item 1 is collected during the adaptive staircase procedure. Items 2, 3, and 4 are collected during both the adaptive staircase procedure and the subsequent tracking task (as well as the training bouts, see SA-2.1). All data will be saved for offline post-test processing and analyses.SA-1.2: Develop the BRTP's Training Module. A single training session begins by administering the Assessment Module to establish the subject's LoB and corresponding overall target excursion amplitude, and computing the unpredictable target disk trajectory based upon it. The Training Module then presents an operator-specified number of training bouts; a single one of which consists of presenting the trajectory for the subject to track for four minutes without stepping, followed by a three minute sitting rest period. Performance data is recorded throughout the tracking period. Training bout and rest period durations can be varied (with the goal that a training session deliver 60 minutes of actual training) to optimize training efficacy and accommodate individual subject needs and capabilities. Subjects will be harnessed while performing the tracking task to guard against falling. As training progresses and the subject's performance improves, the BRTP will present increasingly difficult target trajectories based upon the increased LoBs and corresponding overall target excursion amplitudes as measured by the Assessment Module at the beginning of each training session.Methods Related to Specific Aim 2: Assessment of the BRTP's training efficacy SA-2.1: Conduct the BRTP and MCET training protocols. All subject testing is performed in this Specific Aim. The investigators will screen 90 older men and women with high fall risk, enrolling 80 of these, and completing training for 68, assuming an overall 25% attrition rate.Subjects will be randomly assigned to either the BRTP or MCET training group. Each group will receive 60 minutes of training three times per week for six weeks. BRTP training is as described previously (see SA-1.2). The VA Maryland team developed an MCET protocol for older individuals with balance and mobility disability. The program is individualized to each participant's capacity based on their balance profile and endurance level. Across the six weeks, training advances from five "fundamental" exercises that are essential for instrumental activities of daily living function to 13 exercises, as participants meet metrics for exercise safety and movement quality. Standardized progressions for each exercise advance according to the level of hand contact support required, dose (duration, sets and repetitions), intensity (movement amplitude and cadence), and multi-segmental motor challenge or complexity. The exercise cadence is adjusted up to provide greater challenge to aerobic fitness and is adjusted down to facilitate greater resistive training benefit (i.e. holding a squat longer) or to accommodate the participant's fatigue level. MCET training will be performed in a group setting.All subjects will be assessed with the clinical balance measures (see below) and the BRTP Assessment Module at the same time points before, during, and after training (see SA-2.2).Outcome Measures: The following "clinical measures" of balance, reach, and fall risk will be used to asses training effects induced by the BRTP and MCET.Multi-Directional Reach TestFalls Efficacy Scale, which assesses FoFPhysiological Profile Assessment (PPA)Tinetti Balance Test (Balance Section)Mini Balance Evaluation Systems Test (Mini-BESTest)DASH (Disabilities of the Arm, Shoulder, and Head) TestFalls experienced by each subject, as well as the conditions in which they fell, during and throughout the first year following training.These measures will be obtained on a separate day from the BRTP Assessment and Training procedures so as not to unduly fatigue the test subjects. The investigators will also employ the following BRTP-based measures of balance and reach.RMSERMSD-Primary Outcome MeasureAverage SoBLoB RMSD will be the investigators' primary outcome measure. SA-2.2: Assess the training efficacy of BRTP training in comparison to MCET. Prior to training subjects will undergo double baseline tests 48 hours apart using the clinical measures and the BRTP-related measures. This assessment will be repeated midway through training (three weeks after training begins), immediately post training, and six-weeks after the last training session (retention). Although the investigators include a number of clinical and BRTP-related performance measures in the assessment of training efficacy, RMSD will be the investigators' primary outcome measure. The primary purpose of this study is to assess the efficacy of the BRTP in improving balance. It is possible that while both the BRTP and MCET improve balance the magnitude of the difference in improvement between groups may be small. As a consequence of the relatively modest number of subjects the investigators will be testing (a result of the demands of the testing and the li....

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 27. Okt. Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Recruitment Status: Recruiting Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: April 24, 2020, Last downloaded: ClinicalTrials.gov processed this data on November 01, 2023, Last updated: November 01, 2023

Study ID:	NCT04359888 E3096-R I01RX003096
Veröffentlichungen zur Studie:

fisyears:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	CTG003369951