Variability of Movement on an Altered Inertial Dynamics Task

September 27, 2023 updated by: University of Nebraska
The overall goal of this research is to compare the effects of two different exercise programs on gait function in older adults. The investigators want to determine if participation in lateral stepping exercise program for six weeks will improve gait functions compared to forward walking exercise program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The overall goal of this research is to compare the effects of two different exercise programs on gait function in older adults. It is expected that improved control of foot placement in the lateral stepping task will transfer to improved control during typical forward walking. Moreover, it is expected that lateral stepping gait training will have a greater effect on recurrent fallers older adults than on the non-fallers older adults and young adults. It is also expected that the above beneficial results will be retained in a follow-up test six weeks after completion of the intervention and will result in improvements in common clinical balance tests that are used to assess fall risk. Therefore, in the current proposal, older adults aged 65 years of age and over are being asked to participate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68182
        • University of Nebraska-Omaha, Biomechanics Research Building

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Subjects must

  • be aged between 19 and 35 for the young adult group
  • be over 65 years of age for the older adult groups
  • be independently residing in the community
  • be able to provide informed consent
  • be able to walk independently without an assistive device or 30 minutes in three-minute sections interspersed with rest periods.

The older participants must either have sustained two or more falls in the past year (i.e. Fallers) or not have sustained any falls in the past year (i.e. Non-Fallers).

Exclusion Criteria:

  • Neurological disorder or progressive neurologic condition - epilepsy, Alzheimer disease and other dementias, stroke, multiple sclerosis, Parkinson's disease, brain infections, brain tumors.
  • Movement disorder - ataxia, dystonia, Huntington's disease, myoclonus, Parkinson disease, progressive supranuclear palsy, Wilson disease.
  • History of Cardiovascular events this includes any history of heart problems (such as heart attack, chest pain, or conditions which affect the heart's muscles, valves, or rhythm)
  • Current injury or moderate to severe pain affecting the lower limbs, pelvis, back, trunk.
  • Surgery within the past 6 months.
  • Current participation in any other study that involves walking, balance, or training.

Medications will not prevent inclusion in the study however they will be recorded to enable consideration in subsequent post-hoc analyses.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Recurrent fallers - control group
In this control arm, older adults will have a typical forward walking training that mirror the lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min forward walking. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
Behavioral: Forward walking
Subjects will have a typical forward walking
Other Names:
  • Typical walking
Experimental: Recurrent fallers - intervention group
In this experimental arm, older adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
Behavioral: Lateral stepping
Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
Other Names:
  • Sideways walking
Experimental: Older non-fallers intervention group
In this experimental arm, older adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
Behavioral: Lateral stepping
Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
Other Names:
  • Sideways walking
Active Comparator: Younger adult control group
Outcome measures from a young healthy group will also be measured as a reference. Will be used to compare outcome measured between older and young adults. Young adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
Behavioral: Lateral stepping
Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
Other Names:
  • Sideways walking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Step width variability
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of step width. Step width was measured as the mediolateral distance between the locations of the sequential left and right heel strikes
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Step length variability
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of step length. Step length was measured as the anteroposterior distance between the locations of the sequential left and right heel strikes.
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Swing time variability
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of swing time. Swing time was measured as the time elapse during the swing phase of a leg.
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Stride time variability
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of stride time. Stride time was measured as the time between 2 consecutive ipsilateral heel strikes.
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Stance time variability
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of stance time. Stance time was measured as the time elapse during the stance phase of a leg.
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Timed-Up-and-Go (TUG)
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The Timed-Up-and-Go test is used to assess mobility in older adults. It measures the time to get up from chair, walk 3 m, turn around, walk back, and sit down
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Berg Balance Test (BBS)
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The Berg Balance Test (14 items, max score: 56) is used to measure the functional balance in older adults. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level).
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Self-selected forward walking and sideways walking speed
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Falls Efficacy Scale-International (FES-I)
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The Falls Efficacy Scale-International (FES-I) questionnaire (16 items, max score: 64) is used to assess confidence in the performance of activities relevant to daily life. Participants rate 16 individual activities on a scale from 1 (not at all concerned) to 4 (very concerned).
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory - short form (BPI)
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The short form of Brief Pain Inventory score (BPI) (4 Pain severity items, max score: 40; 7 Pain interference items, max score: 70) is used to measure the impact of pain on daily functions. Higher score suggests higher pain intensity (severity), and/or higher impact of pain on functioning (interference).
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Mini-Mental State Examination (MMSE)
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The Mini-Mental State Examination (MMSE) (11 items, max score: 30) is used to measure cognitive impairment. It consists of 11 questions grouped into 7 cognitive tasks. A score of 30 suggests no presence of cognitive impairment.
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Geriatric Depression Scale - short form (GDS)
Time Frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The Geriatric Depression Scale - short form (GDS) (15 items, max score: 15) is used to measure self-rated depressive symptoms of depression. A score of 5 or more suggests depression.
Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Skiadopoulos, PhD, Research Associate
  • Study Director: Nicholas Stergiou, PhD, Assistant Dean

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0448-16-FB
  • P20GM109090 (U.S. NIH Grant/Contract)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings