Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Learning From Falling: Perturbation-based Training to Prevent Falls in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770103
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Montana State University

Brief Summary:

The investigators will evaluate the difference between a commonly accepted paradigm of balance training (BT) and a more dynamic and task specific form of balance training, perturbation-based training (PBT) in older adults. BT is a key evidenced based strategy for preventing falls in older adults, however it needs to be regular (2hours/week) and long term (>6moths) while the average effect is only moderate (24%). The reason for the moderate effect on falls is like to be the non-specific stimulus presented during BT. That is, training tends to be quasi-static and slow and largely based on movements described as strength training. However, when an individual loses balance, they are most often required to implement a rapid and dynamic response. Furthermore, while older adults who are unable to recover balance well have generally lower strength, our recent work has demonstrated that it is not their force producing capability that limits them. Rather it is the ability to access moderate levels of muscular force very rapidly and early in the recovery step that differentiates successful versus unsuccessful recovery of balance. Importantly, the ability to produce an effective and rapid recovery step is predicative of avoiding future real world falls.

An emerging fall prevention training regimen is perturbation-based training (PBT). PBT involves rapidly disrupting balance requiring the participant to take rapid steps to recover balance. This is commonly achieved on a laboratory treadmill equipped with a safety harness to prevent actual falls during training. By simulating "real-world" balance challenges such as slips and trips, PBT provides a direct means for learning how to recover balance and avoid falls. It has been demonstrated that with only a few PBT sessions, older adults make rapid and dramatic improvements in balance recovery performance, retain the skills long-term and potentially suffer fewer falls over extended periods. This study builds on the previous published work of the PI that describes the key factors related to differences in balance recovery performance, the neuro-motor coordination strategies used during successful and unsuccessful recovery, and currently unpublished pilot studies indicating the efficacy of PBT. To date studies have not directly compared BT regimes recommended by the American College of Sports Medicine (ACSM) against PBT, nor have they evaluated the influence of training on the incidence of real-world falls. In part this may be because PBT currently requires the use of expensive, laboratory treadmills and as such is not accessible by the average independent, community dwelling older adults. A specific randomized study is required and our overall purpose for this study is to compare the balance recovery performance of older adults following either BT or PBT, evaluate differences in the incidence of real-world falls, and develop a safe, effective and portable device for use in future community PBT training studies. The short-term goals are to determine the effect of PBT versus BT and the neuro-motor mechanism of improved recovery behavior.

Aim 1: To evaluate differences in balance recovery behavior in older adults following either balance training (BT) and perturbation-based training (PBT) and the incidence on real-world falls.

H1: Balance recovery performance will improve in both BT and PBT groups but will be significantly better in those completing PBT when compared to BT.

H2: Improvements in balance recovery behavior will be related to improved coordination and neuro-motor control strategies.

H3: Real world loss of balance events will be similar in both BT and PBT but incidence of resulting falls will be lower in the PBT group.


Condition or disease Intervention/treatment Phase
Accidental Falls Behavioral: Balance recovery Behavioral: Postural Sway Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Learning From Falling: Perturbation-based Training to Prevent Falls in Older Adults
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Dynamic
Participants within the dynamic arm will receive either traditional balance training within ACSM guidelines or Dynamic Step training known as Perturbation based training (PBT). Outcome measures assessed will be Margin of Stability during dynamic step recovery when subjected to a forward loss of balance, along with static postural sway ( a measure of postural control not requiring a step recovery). Participants motivation, mental wellness, attitudes to exercise and fear of falling will be assessed prior to the intervention and 6 months following the intervention.
Behavioral: Balance recovery

Balance recovery by stepping ascertains the capability of the participant to recover when subjected to a loss of balance in the forward direction.

Attitudes towards exercise, fear of falling and mental wellness a psychosocial measures to ascertain the relationship between perceptions and physical capability.

Other Names:
  • Attitudes towards exercise
  • Fear of falling
  • Mental Wellness

Experimental: Static
Participants within the static arm will receive only traditional balance training within ACSM guidelines. The outcome measure within the static arm is limited to static postural sway. Participants motivation, mental wellness, attitudes to exercise and fear of falling will be assessed prior to the intervention and 6 months following the intervention.
Behavioral: Postural Sway

Postural sway is a pseudo-static measure of postural control that evaluates a participants balance recovery ability when the perturbation does not require a dynamic step recovery.

Attitudes towards exercise, fear of falling and mental wellness a psychosocial measures to ascertain the relationship between perceptions and physical capability.

Other Names:
  • Attitudes towards exercise
  • Fear of falling
  • Mental Wellness




Primary Outcome Measures :
  1. Margin of stability [ Time Frame: 3 months ]
    Margin of stability describes dynamic stability of an individual during stepping. It quantifies the location of the velocity adjusted center of mass compared to the base of support. Positive numbers reflect stability while negative numbers reflect instability. Margin of stability during balance recovery is related to future fall.

  2. Step length [ Time Frame: 3 months ]
    Difference in the length of the recovery step differentiate individuals who can successfully recover balance compared to those who cannot.

  3. Step time [ Time Frame: 3 months ]
    Difference in the time take to take a recovery step differentiate individuals who can successfully recover balance compared to those who cannot.


Secondary Outcome Measures :
  1. Fall Incidence [ Time Frame: 6 months ]
    The number of real world falls or near misses experienced by an individual on a daily basis.

  2. Fear of Falling [ Time Frame: 6 months ]
    A scale of fear or apprehension related to falling during general physical activity

  3. Attitude towards exercise [ Time Frame: 6 months ]
    A scale rating the participants attitude towards regularly undertaking exercise or physical activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In order to take part in this study, you must meet all of the following criteria:

    • Are aged 60 to 80 years
    • Are living in the community
    • Are a Non-smoker
    • Do not have a recent muscle or joint injury
    • Do not have a progressive musculoskeletal condition (arthritis, osteoporosis etc)

Exclusion Criteria:

  • You will not be able to take part in this study if you meet any one of the following criteria:

    • If you regularly consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription. If you are unsure about the drugs that you are taking, please ask us.
    • You take medication that may make you dizzy or feel unbalanced, please consult with us regarding any prescribed medication you may be taking. Depending on the medication we may need screen you out of the study or ask that you to obtain clearance from your physician prior to being accepted into the study.
    • A history of bone, joint, nerve, muscle problems or a current injury and are unable to obtain physician approval. This includes joint replacements or reconstructive surgery in the ankle, hip or knee joints.
    • If you have had a stroke or have a heart condition for which moderate to vigorous exercise is contraindicated.
    • If your doctor has told you that you should not do exercise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770103


Contacts
Layout table for location contacts
Contact: David Graham, PhD 406-994-4120 david.graham7@montana.edu
Contact: Dawn Tarabochia, PhD 406-994-2057 dawn.tarabochia@montana.edu

Locations
Layout table for location information
United States, Montana
Montana State University, Department of Health and Human Development Recruiting
Bozeman, Montana, United States, 59717
Contact: David Graham, PhD    406-994-4120    david.graham7@montana.edu   
Sub-Investigator: Dawn Tarabochia, PhD         
Principal Investigator: David Graham, PhD         
Sponsors and Collaborators
Montana State University
Layout table for additonal information
Responsible Party: Montana State University
ClinicalTrials.gov Identifier: NCT04770103    
Other Study ID Numbers: DG020320
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are not yet decided with respect to data sharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montana State University:
Balance Recovery