Old Age; DebilityPATNCT06388434
Protective Arm Balance Responses
A study testing Protective Arm Balance Response Training in people with Old Age; Debility and Peripheral Neuropathy, run by University of Maryland, Baltimore at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Peripheral Neuropathy
- What is being tested?
- Protective Arm Balance Response Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 65 to 88 years of age
- Community ambulatory with or without a straight cane
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Allied Health Research Building
Baltimore, Maryland, 21201
About this study
Official title: Influence of Attentional Control on Protective Arm Responses to Balance Perturbations in Older Adults and People With Peripheral Neuropathy
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.
Read the detailed 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:
- 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.
- Stait Trait Anxiety Inventory: Measure of trait and state anxiety
- 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
- 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.
- 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
- Old Age; Debility, Peripheral Neuropathy
- Being tested
- Protective Arm Balance Response Training
- Keywords
- Reactive Balance, Reach to Grasp, Attention Switching
- Medical subject headings
- Frailty, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective Arm Balance Response TrainingBehavioural
Participants will be trained in the reach to grasp arm balance response while being exposed to unpredictable balance perturbations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Protective Arm Balance Response Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
EMG will allow us to record muscle activity during the balance response
Measured: Within the first second following onset of the balance perturbation
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.
Measured: 5 minutes at baseline and 5 minutes during the balance perturbation tasks
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).
Measured: 5 minutes at baseline and 5 minutes during the balance perturbation tasks
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.
Measured: The questions ask about the 4 weeks before the first day of testing
Stait Trait Anxiety Inventory
Measure of trait and state anxiety
Measured: The questions ask about the participants current feelings and their feelings in general over the past year
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
Measured: In the moment immediately following the balance perturbations
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.
Measured: At baseline
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
Measured: The items in the scale ask about the participants feelings over the previous week
Somatosensation
Consists of a comprehensive assessment of somatosensation including proprioception, vibration, light touch, and protective sensation.
Measured: This will be assessed at baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Oct 2023
- Primary completion13 Sep 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Westlake, University of Maryland, Baltimore
- Investigators
- Kelly P Westlake, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388434
- Sponsor's protocol ID
- HP-00100309
- Acronym
- PAT
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available if requested
Publications
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.
PubMed 12689781Marigold 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.
PubMed 12611998Hsiao 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.
PubMed 9596532Hendriks 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.
PubMed 18662214Province 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.
PubMed 7715058Mansfield 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.
PubMed 25524873Bolton 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.
PubMed 21925570Liston 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.
PubMed 19139412Sanger 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.
PubMed 25346669Cheng 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.
PubMed 23635599Powell 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.
PubMed 7814786Padgett 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.
PubMed 22677295Dite 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.
PubMed 12422327Daniels 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.
PubMed 20569651Kim 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.
PubMed 29486547
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Attentional Control on Protective Arm Responses to Balance Perturbations in Older Adults and People With Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06388434
- Acronym / sponsor ID
- PAT / HP-00100309
- Conditions
- Old Age; Debility, Peripheral Neuropathy
- Keywords
- Reactive Balance, Reach to Grasp, Attention Switching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- Stait Trait Anxiety Inventory: Measure of trait and state anxiety
- 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
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention
| Arm | Type | Receives |
|---|---|---|
| Protective Arm Training | Experimental | Behavioral: Protective Arm Balance Response TrainingBoth groups (older adults and people with peripheral neuropathy) will be assessed pre- and post-intervention as well as midway through the training. |
Who may qualify
- Ages
- 45 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 65 to 88 years of age
- Community ambulatory with or without a straight cane
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective Arm Balance Response TrainingParticipants will be trained in the reach to grasp arm balance response while being exposed to unpredictable balance perturbations | Behavioural | Protective Arm Training |
Primary outcome
Grasp Accuracy
Time frame: Within the first second immediately following the balance perturbation onset
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
In-task falls incidence
Time frame: The peak load on the safety harness within the first second of the balance perturbation onset.
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.
9 secondary outcomes
Electromyography (EMG) of the shoulder muscles
Time frame: Within the first second following onset of the balance perturbation
Physiological responses (heart rate variability)
Time frame: 5 minutes at baseline and 5 minutes during the balance perturbation tasks
Physiological responses (electrodermal activity)
Time frame: 5 minutes at baseline and 5 minutes during the balance perturbation tasks
Activity specific balance confidence scale
Time frame: The questions ask about the 4 weeks before the first day of testing
Stait Trait Anxiety Inventory
Time frame: The questions ask about the participants current feelings and their feelings in general over the past year
Subjective Units of Distress Scale
Time frame: In the moment immediately following the balance perturbations
Mini Mental State Examination (MMSE)
Time frame: At baseline
Beck Anxiety Inventory
Time frame: The items in the scale ask about the participants feelings over the previous week
Somatosensation
Time frame: This will be assessed at baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 12689781Kim 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.
- Background: PubMed 12611998Marigold 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.
- Background: PubMed 9596532Hsiao 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.
- Background: PubMed 18662214Hendriks 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.
- Background: PubMed 7715058Province 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.
- Background: PubMed 25524873Mansfield 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.
- Background: PubMed 21925570Bolton 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.
- Background: PubMed 19139412Liston 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.
- Background: PubMed 25346669Sanger 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.
- Background: PubMed 23635599Cheng 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.
- Background: PubMed 7814786Powell 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.
- Background: PubMed 22677295Padgett 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.
- Individual participant dataSharing planned: Yes. De-identified data will be made available if requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly P Westlake, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective Arm Balance Response Training in people with Old Age; Debility and Peripheral Neuropathy, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grasp Accuracy (time frame: Within the first second immediately following the balance perturbation onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388434, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.