Older AdultsNCT04505527

Variability of Movement on an Altered Inertial Dynamics Task

A study testing Lateral stepping and Forward walking in people with Older Adults and Fall Patients, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 19 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Older Adults, Fall Patients
What is being tested?: Lateral stepping and Forward walking
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 28 Nov 2017to 5 May 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Nebraska-Omaha, Biomechanics Research Building
Omaha, Nebraska, 68182

Other trials in United States

About this study

Read the 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.

Conditions: Older Adults, Fall Patients
Being tested: Lateral stepping, Forward walking
Keywords: balance, gait, variability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lateral steppingBehavioural
Also called Sideways walking
Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
Forward walkingBehavioural
Also called Typical walking
Subjects will have a typical forward walking

Study groups in NCT04505527
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Lateral stepping

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Walking speed
Self-selected forward walking and sideways walking speed
Measured: 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).
Measured: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 20175 May 2021

First posted10 Aug 2020
Study start28 Nov 2017
Primary completion5 May 2018
Study completion5 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Older AdultsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04505527
Sponsor's protocol ID: 0448-16-FB
Other IDs: P20GM109090
Status last verified: Sep 2023
First submitted: 2 Aug 2020
Last updated: 29 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33446112

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Variability of Movement on an Altered Inertial Dynamics Task
ClinicalTrials.gov ID: NCT04505527
Acronym / sponsor ID: 0448-16-FB
Conditions: Older Adults, Fall Patients
Keywords: balance, gait, variability
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of NebraskaUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 28 Nov 2017 (actual)
Primary completion: 5 May 2018 (actual)
Study completion: 5 May 2021 (actual)
First posted: 10 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Recurrent fallers - control group	Active comparator	Behavioral: Forward walkingIn 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.
Recurrent fallers - intervention group	Experimental	Behavioral: Lateral steppingIn 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.
Older non-fallers intervention group	Experimental	Behavioral: Lateral steppingIn 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.
Younger adult control group	Active comparator	Behavioral: Lateral steppingOutcome 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.

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lateral steppingAlso: Sideways walkingSubjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.	Behavioural	Older non-fallers intervention group, Recurrent fallers - intervention group, Younger adult control group
Forward walkingAlso: Typical walkingSubjects will have a typical forward walking	Behavioural	Recurrent fallers - control group

Primary outcome

Step width variability
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
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
Step length variability
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
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.
Swing time variability
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of swing time. Swing time was measured as the time elapse during the swing phase of a leg.
Stride time variability
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of stride time. Stride time was measured as the time between 2 consecutive ipsilateral heel strikes.
Stance time variability
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
The standard deviation of stance time. Stance time was measured as the time elapse during the stance phase of a leg.
Timed-Up-and-Go (TUG)
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
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
Berg Balance Test (BBS)
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
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).

2 secondary outcomes

Walking speed
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
Falls Efficacy Scale-International (FES-I)
Time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
Derived from this study: PubMed 33446112Skiadopoulos 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreas Skiadopoulos, PhD principal investigator

Research Associate

Nicholas Stergiou, PhD study director

Assistant Dean

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lateral stepping and Forward walking in people with Older Adults and Fall Patients, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step width variability (time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04505527, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.