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Completed

NCT Number: NCT04505527

Variability of Movement on an Altered Inertial Dynamics Task

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.

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Key information

Conditions

Older Adults Fall Patients

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska-Omaha, Biomechanics Research Building

Omaha, Nebraska, 68182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lateral stepping

Behavioral

Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.

Other names: Sideways walking

Forward walking

Behavioral

Subjects will have a typical forward walking

Other names: Typical walking

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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).

Secondary outcomes

  1. 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

  2. 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).

Other outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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