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.

Study Overview

• Status: Completed
• Conditions: Older Adults; Fall Patients
• Intervention / Treatment: Behavioral: Forward walking; Behavioral: Lateral stepping

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: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Step width variability	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	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	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	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	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Walking speed	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)	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

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory - short form (BPI)	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)	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)	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

• Sponsor: University of Nebraska
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Andreas Skiadopoulos, PhD, Research Associate; Study Director: Nicholas Stergiou, PhD, Assistant Dean

Publications and helpful links

General Publications

• Skiadopoulos A, Stergiou N. Risk-of-falling related outcomes improved in community-dwelling older adults after a 6-week sideways walking intervention: a feasibility and pilot study. BMC Geriatr. 2021 Jan 14;21(1):60. doi: 10.1186/s12877-021-02010-6.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): May 5, 2018
• Study Completion (Actual): May 5, 2021

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: gait; balance; variability
• Other Study ID 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