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

Step Training in Persons Post-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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Perturbation Induced Step training; Other: Voluntary step training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, MD, Maryland, United States, 21210
      • University of Maryland Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perturbation induced step training; Participants will receive 18 sessions over 6 weeks.	Other: Perturbation Induced Step training; A sudden lateral displacement of the treadmill.
Active Comparator: Voluntary Step training; Participants will receive 18 sessions over 6 weeks.	Other: Voluntary step training; Voluntary steps emphasizing speed, movement of center of mass and taking larger steps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step initiation time	Change in Step initiation time measured from the time of the puller or light cue onset to the first foot off the force platform.	Baseline, 6 weeks
First step length	Global step length based on the displacement of the ankle marker normalized by the participants height.	Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
step velocity	The step displacment divided by the time to complete the first step	Baseline, 6 weeks
Step clearance	The vertical displacment of the ankle marker normalized the the body height.	Baseline, 6 weeks
Community Balance & Mobility Scale	Balance measure	Baseline, 6 weeks
Activities Specific Balance Confidence	A self reported measure of balance confidence	Baseline, 6 weeks
Falls	Number of falls	6 months pre-enrollment, 6 months post exercise

Collaborators and Investigators

• Sponsor: Vicki Gray

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: exercise; stroke; falls; balance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 00056550; P30AG028747 (U.S. NIH Grant/Contract); American Heart Association (Other Grant/Funding Number: 14CRP19880025); H133P100014, H133F140027 (Other Grant/Funding Number: National Institute on Disability, Independent Living and Rehabilitation Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data was collected more than 5 years ago.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No