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Behavioural Intervention

Movement Amplification Gait Training for Stroke

N/A

Recruiting

Led By Keith Edward Gordon, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to ambulate over ground for 10 meters with or without a single cane, and/or ankle-foot orthosis

Ability to tolerate 10 minutes of standing

Must not have

Presence of unhealed decubiti or other skin compromise

Presence of aphasia (score of 71/100 on the Mississippi Aphasia Screening Test (MAST))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up arm 2 only: on day 1, participants will perform 45 minutes of treadmill walking. seven days later, participants will perform another 45 minutes of continuous treadmill walking. we will measure average rpe during every 3-minutes of treadmill walking

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how people with chronic stroke improve their balance when walking in challenging environments. The researchers will test a new robotic device that amplifies a person's movements to see if it can help

Who is the study for?

This trial is for individuals who have had a stroke at least 6 months ago, can walk 10 meters with or without support, and can stand for 10 minutes. It's not suitable for those in other gait/balance studies, with cognitive impairment, severe communication issues, excessive muscle stiffness in legs, serious heart/lung disease affecting walking balance, pregnancy, or use of certain braces.

What is being tested?

The study tests whether high-intensity gait training using a robotic device to enhance self-generated movements improves walking balance in people post-stroke. Participants will train on treadmills and in various environments to see if this novel approach helps.

What are the potential side effects?

Potential side effects may include fatigue due to the intensity of the exercises and discomfort from using the robotic device during training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk 10 meters with or without help from a cane or brace.

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I can stand for at least 10 minutes without issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have open sores or skin issues that haven't healed.

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I have difficulty with speaking or understanding language.

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I have severe muscle stiffness in my legs.

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I have severe heart or lung disease that affects my walking and balance.

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I have had repeated fractures or bone issues in my legs that affect how I walk and balance.

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I have a brain injury or nerve damage in my legs that affects how I walk and balance.

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I have been diagnosed with cerebellar ataxia.

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I use braces or orthotics that cross my knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ arm 2 only: on day 1, participants will perform 45 minutes of treadmill walking. seven days later, participants will perform another 45 minutes of continuous treadmill walking. we will measure average speed during every 3-minutes of treadmill walking

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~arm 2 only: on day 1, participants will perform 45 minutes of treadmill walking. seven days later, participants will perform another 45 minutes of continuous treadmill walking. we will measure average speed during every 3-minutes of treadmill walking

This trial's timeline: 3 weeks for screening, Varies for treatment, and arm 2 only: on day 1, participants will perform 45 minutes of treadmill walking. seven days later, participants will perform another 45 minutes of continuous treadmill walking. we will measure average speed during every 3-minutes of treadmill walking for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart Rate

Lateral center of mass (COM) excursion during walking

Minimum lateral margin of stability

+3 more

Secondary study objectives

10 Meter Walk Test (10MWT)

Activities-specific Balance Confidence (ABC) Scale

Berg Balance Scale (BBS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Heart Rate Response to Balance Challenging EnvironmentsExperimental Treatment1 Intervention

Aim 2 is a feasibility study to determine if high intensity gait training can be achieved within a MAE. For Aim 2, the investigators will employ a two-way cross over study design consisting of two gait training sessions (one in a natural unmodified environment and the other in a MAE). The investigators will examine cardiovascular response, perceived exertion, and gait characteristics (speed, number of steps) to quantify if the MAE impacts training intensity. All enrolled participants will undergo clinical outcome measure assessments. In addition, all participants for Aim 2, heart rate (HR), rate of perceived exertion (RPE), number of steps taken during the training sessions, and walking speeds will be recorded.

Group II: Biomechanical Response to Balance Challenging EnvironmentsExperimental Treatment1 Intervention

Aim 1 will determine how people with chronic stroke (PwCS) adapt their gait in response to different balance challenging environments. For Aim 1, the investigators will conduct a single-session cross sectional study to assess gait patterns during and immediately following walking practiced in balance challenging environments. PwCS will perform treadmill walking in a natural unmodified environment, and in two balance-challenging environments that will include a Movement Amplification Environment (MAE), and an unpredictable lateral perturbation environment. All enrolled participants will undergo clinical outcome measure assessments to identify baseline function. In addition, all participants in Aim 1 will undergo biomechanical testing while walking in each of the three environments to assess changes in their walking patterns.

0 / 10Eligibility criteria met