Variability of Movement on an Altered Inertial Dynamics Task

Older Adults Clinical Trial

Official title:

Variability of Movement on an Altered Inertial Dynamics Task

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505527
• Other study ID #: 0448-16-FB
• Secondary ID: P20GM109090
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: May 5, 2021

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fall Patients
• Older Adults

Intervention

Behavioral:
• Lateral stepping
Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
• Forward walking
Subjects will have a typical forward walking

Locations

Country	Name	City	State
United States	University of Nebraska-Omaha, Biomechanics Research Building	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Walking speed	Self-selected forward walking and sideways walking speed	Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Secondary	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