Protective Arm Balance Responses (PAT)

April 24, 2024 updated by: University of Maryland, Baltimore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Allied Health Research Building
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within the first second immediately following the balance perturbation onset
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.
The peak load on the safety harness within the first second of the balance perturbation onset.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography (EMG) of the shoulder muscles
Time Frame: Within the first second following onset of the balance perturbation
EMG will allow us to record muscle activity during the balance response
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
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
Physiological responses (electrodermal activity)
Time Frame: 5 minutes at baseline and 5 minutes during the balance perturbation tasks
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
Activity specific balance confidence scale
Time Frame: The questions ask about the 4 weeks before the first day of testing
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
Stait Trait Anxiety Inventory
Time Frame: The questions ask about the participants current feelings and their feelings in general over the past year
Measure of trait and state anxiety
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
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
Mini Mental State Examination (MMSE)
Time Frame: At baseline
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
Beck Anxiety Inventory
Time Frame: The items in the scale ask about the participants feelings over the previous week
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
Somatosensation
Time Frame: This will be assessed at baseline only
Consists of a comprehensive assessment of somatosensation including proprioception, vibration, light touch, and protective sensation.
This will be assessed at baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Kelly P Westlake, PhD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00100309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available if requested

IPD Sharing Time Frame

Will be made available upon publication of results

IPD Sharing Access Criteria

Access will be granted through the published article or upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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