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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT06638476
• Lead Sponsor: Vicki Gray

Brief Summary

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.

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 Timeline

• Study Start: 2014-09-01
• Primary Completion: 2017-09-30
• Study Completion: 2018-03-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Step initiation time	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.
First step length	Baseline, 6 weeks	Global step length based on the displacement of the ankle marker normalized by the participants height.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland Baltimore; 🇺🇸 Baltimore, MD, Maryland, United States