Protective Arm Balance Responses

Peripheral Neuropathy Clinical Trial

— PAT  

Official title:

Influence of Attentional Control on Protective Arm Responses to Balance Perturbations in Older Adults and People With Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388434
• Other study ID #: HP-00100309
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: Kelly P Westlake, PhD
• Phone: 410-706-5919
• Email: kwestlake[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 88 Years

Eligibility

Inclusion Criteria:

• 65 to 88 years of age

• Community ambulatory with or without a straight cane

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Frailty
• Old Age; Debility
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Behavioral:
• Protective Arm Balance Response Training
Participants will be trained in the reach to grasp arm balance response while being exposed to unpredictable balance perturbations

Locations

Country	Name	City	State
United States	Allied Health Research Building	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (18)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kim KJ, Ashton-Miller JA. Biomechanics of fall arrest using the upper extremity: age differences. Clin Biomech (Bristol, Avon). 2003 May;18(4):311-8. doi: 10.1016/s0268-0033(03)00005-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Electromyography (EMG) of the shoulder muscles	EMG will allow us to record muscle activity during the balance response	Within the first second following onset of the balance perturbation
Secondary	Physiological responses (heart rate variability)	Heart rate variability informs us about the ability of the heart to adapt to different stressors by calculating the variability in heart rate during different tasks.	5 minutes at baseline and 5 minutes during the balance perturbation tasks
Secondary	Physiological responses (electrodermal activity)	Electrodermal activity informs us about the amount of stress in the body during various tasks by calculating the amount of sweat produced during the task (the more we sweat, the more stressed we are).	5 minutes at baseline and 5 minutes during the balance perturbation tasks
Secondary	Activity specific balance confidence scale	Questions are on how confidence subjects feel when performing normal activities of daily living that involves maintaining their dynamic balance.	The questions ask about the 4 weeks before the first day of testing
Secondary	Stait Trait Anxiety Inventory	Measure of trait and state anxiety	The questions ask about the participants current feelings and their feelings in general over the past year
Secondary	Subjective Units of Distress Scale	Measures anxiety and distress on a scale of 0 no distress and totally relaxed to 100 highest distress/ anxiety ever felt	In the moment immediately following the balance perturbations
Secondary	Mini Mental State Examination (MMSE)	A validated sensitive test for detecting mild cognitive impairments. It involves documenting your responses to cognitive tasks such as subtractions, memory recall repeating number sequences, naming as many nouns starting with "F" etc.	At baseline
Secondary	Beck Anxiety Inventory	Consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week	The items in the scale ask about the participants feelings over the previous week
Secondary	Somatosensation	Consists of a comprehensive assessment of somatosensation including proprioception, vibration, light touch, and protective sensation.	This will be assessed at baseline only