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Variability of Movement on an Altered Inertial Dynamics Task

Variability of Movement on an Altered Inertial Dynamics Task

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04505527
Enrollment
15
Registered
2020-08-10
Start date
2017-11-28
Completion date
2021-05-05
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older Adults, Fall Patients

Keywords

balance, gait, variability

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.

Interventions

BEHAVIORALLateral stepping

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

BEHAVIORALForward walking

Subjects will have a typical forward walking

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Nebraska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance Test (BBS)Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe 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).
Stride time variabilityBaseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe standard deviation of stride time. Stride time was measured as the time between 2 consecutive ipsilateral heel strikes.
Stance time variabilityBaseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe standard deviation of stance time. Stance time was measured as the time elapse during the stance phase of a leg.
Step width variabilityBaseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe standard deviation of step width. Step width was measured as the mediolateral distance between the locations of the sequential left and right heel strikes
Step length variabilityBaseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe standard deviation of step length. Step length was measured as the anteroposterior distance between the locations of the sequential left and right heel strikes.
Timed-Up-and-Go (TUG)Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe 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
Swing time variabilityBaseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe standard deviation of swing time. Swing time was measured as the time elapse during the swing phase of a leg.

Secondary

MeasureTime frameDescription
Walking speedBaseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionSelf-selected forward walking and sideways walking speed
Falls Efficacy Scale-International (FES-I)Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe 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

MeasureTime frameDescription
Mini-Mental State Examination (MMSE)Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe 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.
Geriatric Depression Scale - short form (GDS)Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe 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.
Brief Pain Inventory - short form (BPI)Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the interventionThe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026