Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388434
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-07-11
Brief Title:
Protective Arm Balance Responses
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Influence of Attentional Control on Protective Arm Responses to Balance Perturbations in Older Adults and People With Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAT
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
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 wwwsimbexcom 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
Assessment
Using a specialized treadmill that induces balance perturbations ActiveStep wwwsimbexcom 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None