Clinical trial NCT03813342: Retraining the Walking Pattern After Stroke
Official title: Retraining the Walking Pattern After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: stroke
gait training
visual feedback
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-01-23
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: treadmill with multi-dimensional and one-dimensional feedback
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effects of pairing gait training with different forms of visual feedback about leg movements in individual post-stroke to modify/normalize their gait pattern over time.

Detailed description: Stroke often results in functional gait deficits and abnormal gait patterns. Typically, several features of gait are altered (e.g. knee joint movement decreases and step lengths are asymmetric). Data show that walking patterns after neurologic injury can be changed through gait training, but traditional rehabilitation approaches typically focus on changing one feature of gait at a time. However, the investigators have recently shown that in a single session individuals post-stroke are able to learn to change multiple components of this impaired gait pattern at the same time.

To further leverage this ability to learn multiple things at once, the investigators have also studied how different forms of visual feedback about leg movements may best facilitate individuals to make meaningful changes to multiple features of the gait pattern. Specifically, they have studied two forms of visual feedback - 1) multidimensional, with multiple streams of information about leg movements, and 2) one-dimensional, which distills/summarizes multiple pieces of information about the gait pattern into a single source of feedback. They have shown that the one-dimensional summary feedback is more effective to help people learn a new gait pattern that requires changing multiple features of how they are walking. This work has focused on single training sessions in neurologically intact individuals, but the authors would like to study the effects of longer-term training with these different forms of feedback. Therefore, the purpose of this study is to gather preliminary data to inform the design of a clinical trial of gait training to treat walking deficits post-stroke. The investigators will gather data to determine whether training with different forms of visual feedback about leg movements are effective at improving gait patterns post-stroke - and which form of feedback may be more effective.

The investigators will study adults with cerebral damage due to stroke. Subjects with hemiparesis will undergo training 3 times a week for a total of 12 training session. These 12 sessions will be broken into 2 blocks of 6 sessions, with at least a 2 week break in between. In each block, training will occur with one form of visual (multi- or one-dimensional). Participants will complete training with both forms of feedback, the order of feedback forms will be randomly assigned. These studies will provide important new information about gait training with visual feedback in individuals post-stroke. This study is critical for developing procedural reliability processes, calculating effect sizes, and determining other salient clinical variables in preparation for a randomized clinical trial.

Eligibility criteria: Inclusion Criteria:

* stroke or hemiparesis (\>6 months post stroke)
* able to walk but has a residual gait deficit (including those who walk with a cane or walker)
* Able to walk for 5 minutes at their self-paced speed
* Adults age 20-80

Exclusion Criteria:

* Cerebellar signs (e.g.ataxic hemiparesis)
* Any neurologic condition other than stroke
* Uncontrolled diabetes
* Congestive heart failure
* Peripheral artery disease with claudication
* Pulmonary or renal failure
* Unstable angina
* Uncontrolled hypertension (\>190/110 mmHg)
* MoCA (Montreal Cognitive Assessment Test for Dementia) \< 23
* Severe aphasia
* Orthopedic or pain conditions that limit walking
* Pregnancy

Primary outcomes:
measure: 1. Change in hip and knee joint movements while walking
timeFrame: Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
Secondary outcomes:
measure: 1. Change in walking speed
timeFrame: Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
measure: 2. Change in subjective assessment of balance confidence
timeFrame: Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Motion Analysis Lab in the Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Kennedy Krieger Institute and Johns Hopkins School of Medicine
name: Amy J Bastian, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: