Clinical trial NCT04505527: Variability of Movement on an Altered Inertial Dynamics Task
Official title: Variability of Movement on an Altered Inertial Dynamics Task
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Fall Patients
Keywords: balance
gait
variability
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-08-10
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Step width variability
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Step length variability
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Swing time variability
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Stride time variability
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Stance time variability
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Timed-Up-and-Go (TUG)
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Berg Balance Test (BBS)
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Secondary outcomes:
measure: Walking speed
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Other outcomes:
measure: Brief Pain Inventory - short form (BPI)
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
measure: Geriatric Depression Scale - short form (GDS)
timeFrame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Locations:
city: Omaha
country: United States
facility: University of Nebraska-Omaha, Biomechanics Research Building
state: Nebraska
Study officials:
affiliation: Research Associate
name: Andreas Skiadopoulos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Dean
name: Nicholas Stergiou, PhD
role: STUDY_DIRECTOR
References:
citation: 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.