Variability of Movement on an Altered Inertial Dynamics Task

NCT04505527 | Completed

• 2 other identifiers: 0448-16-FBP20GM109090
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adults; Fall Patients

Keywords

balance; gait; variability

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Walking speed

  Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

• Falls Efficacy Scale-International (FES-I)

  Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Other Outcomes (3)

• Brief Pain Inventory - short form (BPI)

  Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

• Mini-Mental State Examination (MMSE)

  Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

• Geriatric Depression Scale - short form (GDS)

  Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Study Arms (4)

Recurrent fallers - control group

ACTIVE COMPARATOR

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

Recurrent fallers - intervention group

EXPERIMENTAL

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

Older non-fallers intervention group

EXPERIMENTAL

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

Younger adult control group

ACTIVE COMPARATOR

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

Interventions

Lateral stepping BEHAVIORAL

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

Also known as: Sideways walking

Older non-fallers intervention group; Recurrent fallers - intervention group; Younger adult control group

Forward walking BEHAVIORAL

Subjects will have a typical forward walking

Also known as: Typical walking

Recurrent fallers - control group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nebraska-Omaha, Biomechanics Research Building

Omaha, Nebraska, 68182, United States

Location

Related Publications (1)

• 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.

  PMID: 33446112 DERIVED

Study Officials

• Andreas Skiadopoulos, PhD

  Research Associate

  PRINCIPAL INVESTIGATOR

• Nicholas Stergiou, PhD

  Assistant Dean

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Older adults will be screened and will be randomly assigned to three groups - (i) non-fallers, (ii) recurrent fallers - control group, and (iii) recurrent fallers - intervention group. A fourth group consisted of healthy young adults. This group will receive lateral stepping intervention and outcomes will be measured as a reference.

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 10, 2020
• Study Start: November 28, 2017
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2021
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

US (1)