AzTrials
AzTrials

StrokeNCT03813342

Retraining the Walking Pattern After Stroke

A study testing Gait training with visual feedback of joint kinematics in people with Stroke and Hemiparesis, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Stroke, Hemiparesis
What is being tested?
Gait training with visual feedback of joint kinematics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
6 Feb 2019to 21 Dec 2023
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Motion Analysis Lab in the Kennedy Krieger Institute

    Baltimore, Maryland, 21205

Other trials in United States

About this study

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.

Read the 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.

Conditions
Stroke, Hemiparesis
Being tested
Gait training with visual feedback of joint kinematics
Keywords
stroke, gait training, visual feedback
Medical subject headings
Stroke, Paresis

What participants receive

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

  • Gait training with visual feedback of joint kinematicsBehavioural

    Gait training will be accomplished using a Woodway treadmill. The visual feedback will contain information about the real-time lower-limb joint angles. We will instruct participants to use the feedback to reach a target walking pattern.

Study groups in NCT03813342
Study groupRoleWhat they receive
Multichannel Visual FeedbackExperimentalGait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 4 channels of visual information, each of which represents a joint angle (right and left hips, right and left knees).
Receives: Behavioral: Gait training with visual feedback of joint kinematics
Single Channel Visual FeedbackExperimentalGait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 1 channel of visual information that encompasses information from 4 lower limb joint angles (right and left hips, right and left knees).
Receives: Behavioral: Gait training with visual feedback of joint kinematics

What is being measured

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

  1. 1. Change in hip and knee joint movements while walking

    How closely the hip and knee movements in participants post-stroke match those of a healthy gait patter. To collect this measure, subjects will wear special markers on their feet and body to record how their legs are moving while they walk on the treadmill.

    Measured: 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 (2)
  1. 1. Change in walking speed

    Subjects will complete clinical tests of walking speed by walking overground at two paces - their normal comfortable pace and as fast as safely possible.

    Measured: 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.

  2. 2. Change in subjective assessment of balance confidence

    Subjects will complete the 16-item Activities-Specific Balance Confidence Scale. This is a self-report measure in which they rate their confidence that they would not lose their balance while performing specific daily activities. Scores can range from 0 - 100, with 0 indicating the respondent has no confidence in their balance and 100 indicating that they are full confident that they can perform all items without a loss of balance. As such, higher values represent a better outcome. There are no sub-scales for this measure.

    Measured: 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.

Timeline

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

  1. First posted23 Jan 2019
  2. Study start6 Feb 2019
  3. Primary completion20 Dec 2023
  4. Study completion21 Dec 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
treadmill with multi-dimensional and one-dimensional feedback
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03813342
Sponsor's protocol ID
IRB00097573
Other IDs
2R37NS090610
Status last verified
Jun 2024
First submitted
14 Jan 2019
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Gait training with visual feedback of joint kinematics in people with Stroke and Hemiparesis, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 4 inclusion and 12 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 4 Jun 2024. 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?

1. Change in hip and knee joint movements while walking (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Jun 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in