Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2023-10-01
2024-12-13
Brief Summary
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Participants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training.
Detailed Description
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Assessment:
Using a specialized treadmill that induces balance perturbations (ActiveStep, www.simbex.com), an individualized perceived balance threshold will first be assessed. In brief, participants will stand feet together, arms relaxed at their sides, eyes focused on a red 'X' at eye level and asked only to grasp when participants feel a true need to restore balance. Testing perturbations will proceed 2 levels above this threshold. Next, two lateral perturbation conditions, each with 10 trials (5x right; 5x left) will be randomly applied. Perturbation direction and timing will be unknown and random. Condition 1 has no cognitive task. Condition 2 has participants engaged in a cognitive task 30-120s prior to perturbation with instructions, "as soon as the participant feels a falling sensation, stop the task and grab a single rail to quickly restore balance." To promote high cognitive task engagement, a mental arithmetic task was selected as one of the most effective stressors. Psychophysiological stressors are known to result in greater task engagement than pleasant tasks, thus adding a consistent challenge to task inhibition and in turn, attention switching. To allow characterization of the 'first trial response', the first and second trial will include one of each condition, separated by a 5min rest. The 'first trial response' has less stability compared with subsequent perturbations and is relevant to the study of mechanisms underlying 'real-life' falls. Objective kinematic and electromyographic (EMG) assessment of balance responses to the perturbations will be conducted. Following the balance perturbation assessment, clinical tests of balance, including the four square step test and miniBEST, will be conducted. The investigators will also be using a device to record physiological responses using sensors attached to the fingers (Biopac Systems, Inc.) to record stress at baseline and during the reactive balance responses assessment.
Subjects will also complete questionnaires on balance confidence and anxiety. These include:
1. Activity specific balance confidence scale (ABC): Questions are on how confidence subjects feel when performing normal activities of daily living that involves maintaining their dynamic balance.
2. Stait Trait Anxiety Inventory: Measure of trait and state anxiety
3. Subjective Units of Distress Scale (SUDS): Measures anxiety and distress on a scale of 0 no distress and totally relaxed to 100 highest distress/ anxiety ever felt
4. Mini Mental State Examination (MMSE): A validated sensitive test for detecting mild cognitive impairments. It involves documenting the participants responses to cognitive tasks such as c subtractions, memory recall repeating number sequences, naming as many nouns starting with "F" etc.
5. Beck Anxiety Inventory (BAI): Consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week
Training:
Participants will each undergo 6 sessions of an attention task combined with balance perturbation and upper limb responses. The investigators define feasibility in terms of whether key components of our approach are met, including valid and reliable pre-perturbation cognitive engagement and reactive arm recovery responses over repeated trials, as well as overall participant satisfaction.
Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
OTHER
NONE
Study Groups
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Protective Arm Training
Both groups (older adults and people with peripheral neuropathy) will be assessed pre- and post-intervention as well as midway through the training.
Protective Arm Balance Response Training
Participants will be trained in the reach to grasp arm balance response while being exposed to unpredictable balance perturbations
Interventions
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Protective Arm Balance Response Training
Participants will be trained in the reach to grasp arm balance response while being exposed to unpredictable balance perturbations
Eligibility Criteria
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Inclusion Criteria
* Community ambulatory with or without a straight cane
Exclusion Criteria
* Clinically identified uncorrected visual loss
* Complaints of dizziness or known vestibular disorder
* Upper extremity strength less than 4/5 manual muscle test at the shoulder, elbow, wrist, or grip.
* Mini Mental State Examination score of less than 25
45 Years
88 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Kelly Westlake
PI
Principal Investigators
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Kelly P Westlake, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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Allied Health Research Building
Baltimore, Maryland, United States
Countries
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References
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Stevens JA, Mahoney JE, Ehrenreich H. Circumstances and outcomes of falls among high risk community-dwelling older adults. Inj Epidemiol. 2014 Mar 20;1(5):5. doi: 10.1186/2197-1714-1-5.
Kim KJ, Ashton-Miller JA. Biomechanics of fall arrest using the upper extremity: age differences. Clin Biomech (Bristol). 2003 May;18(4):311-8. doi: 10.1016/s0268-0033(03)00005-6.
Marigold DS, Bethune AJ, Patla AE. Role of the unperturbed limb and arms in the reactive recovery response to an unexpected slip during locomotion. J Neurophysiol. 2003 Apr;89(4):1727-37. doi: 10.1152/jn.00683.2002. Epub 2002 Dec 11.
Hsiao ET, Robinovitch SN. Common protective movements govern unexpected falls from standing height. J Biomech. 1998 Jan;31(1):1-9. doi: 10.1016/s0021-9290(97)00114-0.
Hendriks MR, Bleijlevens MH, van Haastregt JC, Crebolder HF, Diederiks JP, Evers SM, Mulder WJ, Kempen GI, van Rossum E, Ruijgrok JM, Stalenhoef PA, van Eijk JT. Lack of effectiveness of a multidisciplinary fall-prevention program in elderly people at risk: a randomized, controlled trial. J Am Geriatr Soc. 2008 Aug;56(8):1390-7. doi: 10.1111/j.1532-5415.2008.01803.x. Epub 2008 Jul 24.
Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.
Mansfield A, Wong JS, Bryce J, Knorr S, Patterson KK. Does perturbation-based balance training prevent falls? Systematic review and meta-analysis of preliminary randomized controlled trials. Phys Ther. 2015 May;95(5):700-9. doi: 10.2522/ptj.20140090. Epub 2014 Dec 18.
Bolton DAE, Patel R, Staines WR, McIlroy WE. Transient inhibition of primary motor cortex suppresses hand muscle responses during a reactive reach to grasp. Neurosci Lett. 2011 Oct 24;504(2):83-87. doi: 10.1016/j.neulet.2011.09.001. Epub 2011 Sep 10.
Liston C, McEwen BS, Casey BJ. Psychosocial stress reversibly disrupts prefrontal processing and attentional control. Proc Natl Acad Sci U S A. 2009 Jan 20;106(3):912-7. doi: 10.1073/pnas.0807041106. Epub 2009 Jan 12.
Sanger J, Bechtold L, Schoofs D, Blaszkewicz M, Wascher E. The influence of acute stress on attention mechanisms and its electrophysiological correlates. Front Behav Neurosci. 2014 Oct 9;8:353. doi: 10.3389/fnbeh.2014.00353. eCollection 2014.
Cheng KC, Pratt J, Maki BE. Effects of spatial-memory decay and dual-task interference on perturbation-evoked reach-to-grasp reactions in the absence of online visual feedback. Hum Mov Sci. 2013 Apr;32(2):328-42. doi: 10.1016/j.humov.2012.11.001. Epub 2013 Apr 29.
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
Padgett PK, Jacobs JV, Kasser SL. Is the BESTest at its best? A suggested brief version based on interrater reliability, validity, internal consistency, and theoretical construct. Phys Ther. 2012 Sep;92(9):1197-207. doi: 10.2522/ptj.20120056. Epub 2012 Jun 7.
Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
Daniels JK, McFarlane AC, Bluhm RL, Moores KA, Clark CR, Shaw ME, Williamson PC, Densmore M, Lanius RA. Switching between executive and default mode networks in posttraumatic stress disorder: alterations in functional connectivity. J Psychiatry Neurosci. 2010 Jul;35(4):258-66. doi: 10.1503/jpn.090175.
Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28.
Andersson S, Finset A. Heart rate and skin conductance reactivity to brief psychological stress in brain-injured patients. J Psychosom Res. 1998 Jun;44(6):645-56. doi: 10.1016/s0022-3999(97)00305-x.
Carriere JSA, Seli P, Smilek D. Wandering in both mind and body: individual differences in mind wandering and inattention predict fidgeting. Can J Exp Psychol. 2013 Mar;67(1):19-31. doi: 10.1037/a0031438.
Other Identifiers
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HP-00100309
Identifier Type: -
Identifier Source: org_study_id