Variability of Movement on an Altered Inertial Dynamics Task

Study Overview
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Brief Summary
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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
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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.

Official Title
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Variability of Movement on an Altered Inertial Dynamics Task

Conditions
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Older Adults, Fall Patients

Intervention / Treatment
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* Behavioral: Lateral stepping
* Behavioral: Forward walking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recurrent fallers - control group<br>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<br>* Subjects will have a typical forward walking<br>* Other names: Typical walking;|
| Experimental: Recurrent fallers - intervention group<br>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<br>* Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.<br>* Other names: Sideways walking;|
| Experimental: Older non-fallers intervention group<br>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<br>* Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.<br>* Other names: Sideways walking;|
| Active Comparator: Younger adult control group<br>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<br>* Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.<br>* Other names: Sideways walking;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, gait, variability