Protective Arm Balance Responses

NCT06388434 | Completed DMC

• 1 other identifier: HP-00100309
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults. 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.

Conditions

Old Age; Debility; Peripheral Neuropathy

Keywords

Reactive Balance; Reach to Grasp; Attention Switching

Outcome Measures

Primary Outcomes (2)

• Grasp Accuracy

  Grasp accuracy refers to the success of the reach to grasp response. This can be a full grasp (grasping with all 5 fingers), overshoot, or undershoot of the handrail

  Within the first second immediately following the balance perturbation onset

• In-task falls incidence

  A load cell attached to the overhead safety harness will record the percentage of the participants body weight that is being supported by the harness. If the harness is holding up more than 30% of the participants body weight, this is considered a fall, 4.5-30% of the participants body weight is considered a harness-assist, and less than 4.5% of the participants body weight is considered recovery.

  The peak load on the safety harness within the first second of the balance perturbation onset.

Secondary Outcomes (9)

• Electromyography (EMG) of the shoulder muscles

  Within the first second following onset of the balance perturbation

• Physiological responses (heart rate variability)

  5 minutes at baseline and 5 minutes during the balance perturbation tasks

• Physiological responses (electrodermal activity)

  5 minutes at baseline and 5 minutes during the balance perturbation tasks

• Activity specific balance confidence scale

  The questions ask about the 4 weeks before the first day of testing

• Stait Trait Anxiety Inventory

  The questions ask about the participants current feelings and their feelings in general over the past year

Study Arms (1)

Protective Arm Training

EXPERIMENTAL

Both groups (older adults and people with peripheral neuropathy) will be assessed pre- and post-intervention as well as midway through the training.

Behavioral: Protective Arm Balance Response Training

Interventions

Protective Arm Balance Response Training BEHAVIORAL

Participants will be trained in the reach to grasp arm balance response while being exposed to unpredictable balance perturbations

Protective Arm Training

Eligibility Criteria

• Age: 45 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 88 years of age
• Community ambulatory with or without a straight cane

You may not qualify if:

• Significant musculoskeletal or neurological impairments as indicated by limitations in activities of daily living, ADL (less than 6/6 on Katz Index in ADLs)
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Allied Health Research Building

Baltimore, Maryland, 21201, United States

Location

Related Publications (18)

• 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.

  PMID: 26744637 BACKGROUND

• 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.

  PMID: 12689781 BACKGROUND

• 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.

  PMID: 12611998 BACKGROUND

• 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.

  PMID: 9596532 BACKGROUND

• 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.

  PMID: 18662214 BACKGROUND

• 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.

  PMID: 7715058 BACKGROUND

• 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.

  PMID: 25524873 BACKGROUND

• 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.

  PMID: 21925570 BACKGROUND

• 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.

  PMID: 19139412 BACKGROUND

• 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.

  PMID: 25346669 BACKGROUND

• 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.

  PMID: 23635599 BACKGROUND

• 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.

  PMID: 7814786 BACKGROUND

• 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.

  PMID: 22677295 BACKGROUND

• 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.

  PMID: 12422327 BACKGROUND

• 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.

  PMID: 20569651 BACKGROUND

• 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.

  PMID: 29486547 BACKGROUND

• 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.

  PMID: 9678746 BACKGROUND

• 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.

  PMID: 23458548 BACKGROUND

MeSH Terms

Conditions

Frailty; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Kelly P Westlake, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: April 29, 2024
• Study Start: October 1, 2023
• Primary Completion: September 13, 2024
• Study Completion: December 13, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Will be made available upon publication of results
• Access Criteria: Access will be granted through the published article or upon reasonable request

Locations

US (1)