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Completed

NCT Number: NCT06638476

Lateral Perturbation Induced Step Training Compared to Lateral Voluntary Step Training in People with Chronic Stroke

The goal of this clinical trial is to see if perturbation-induced step training improves stepping performance during a reactive and voluntary step. The main questions it aims to answer are:

Does perturbation induced step training improve step initation time and first recovery step?

Researchers will compare lateral perturbation induced step training to lateral voluntary step training to see if the first recovery steps improve.

Participants will:

Vist the lab for an initial assessment, post exercise and one month post exercise of voluntary and perturbation induced stepping performance, and clinical tests of balance, motor recovery, sensory and strength tests.

Exercise 3 times a week for 6 weeks in person

Track falls for 6 months after the exercise.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Baltimore

Baltimore, MD, Maryland, 21210, United States

About this study

Stroke is the leading cause of disability in the United States as the result of an increased survival rate over the last 25 years. A high frequency of falls is commonly reported in this group due to the residual sensorimotor deficits and impairments to balance. Many falls occur when weight is transferred laterally and an equal number of falls happen during voluntary movements as during unexpected disturbances such as a trip, push or pull. Typically, either will involve a protective step to recover balance. Thus, the purpose of this study is to compare the effects of reactive lateral step training to voluntary lateral step training on the performance of the protective step, functional balance and falls in persons post-stroke. Thirty participants with a stroke will be randomized to one of two interventions, reactive step training or voluntary step training. In the voluntary step training group, participants will perform voluntary steps. In the reactive step training group, participants will perform reactive steps generated by the Active Step. The training will be 3 times a week for 6 weeks. The step initiation time, will be compared in both the voluntary and reactive steps at baseline before the intervention, post-intervention and a test of retention will occur one month after the training. Functional balance will be assessed with the Community Balance & Mobility Scale and falls will be compared in the 6 months preceding the intervention to 6 months post-intervention testing. If reactive step training is effective, then the protective step characteristics, functional balance and the number of falls will be reduced compared to the voluntary step training group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemiparesis as a result of a stroke greater than 6 months previous to the study
  • Able to walk 10 meters with or without a walking aid
  • Have the cognitive ability to give informed consent

Exclusion criteria

  • Medical condition precluding participation in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies.
  • Bilateral stroke or a previous stroke in the contralateral hemisphere.
  • Aphasia

Treatment and study plan

Perturbation Induced Step training

Other

A sudden lateral displacement of the treadmill.

Voluntary step training

Other

Voluntary steps emphasizing speed, movement of center of mass and taking larger steps.

Primary outcomes

  1. Step initiation time

    Time frame: Baseline, 6 weeks

    Change in Step initiation time measured from the time of the puller or light cue onset to the first foot off the force platform.

  2. First step length

    Time frame: Baseline, 6 weeks

    Global step length based on the displacement of the ankle marker normalized by the participants height.

Secondary outcomes

  1. step velocity

    Time frame: Baseline, 6 weeks

    The step displacment divided by the time to complete the first step

  2. Step clearance

    Time frame: Baseline, 6 weeks

    The vertical displacment of the ankle marker normalized the the body height.

  3. Community Balance & Mobility Scale

    Time frame: Baseline, 6 weeks

    Balance measure

  4. Activities Specific Balance Confidence

    Time frame: Baseline, 6 weeks

    A self reported measure of balance confidence

  5. Falls

    Time frame: 6 months pre-enrollment, 6 months post exercise

    Number of falls

Sponsors and collaborators

Lead sponsor

Vicki Gray

Other

Registry information

Official study title

Step Training in Persons Post-stroke

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 15, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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