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

NCT06638476 | Completed DMC

• 4 other identifiers: 00056550American Heart AssociationH133P100014, H133F140027P30AG028747
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

balance; exercise; falls; stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• step velocity

  Baseline, 6 weeks

• Step clearance

  Baseline, 6 weeks

• Community Balance & Mobility Scale

  Baseline, 6 weeks

• Activities Specific Balance Confidence

  Baseline, 6 weeks

• Falls

  6 months pre-enrollment, 6 months post exercise

Study Arms (2)

Perturbation induced step training

EXPERIMENTAL

Participants will receive 18 sessions over 6 weeks.

Other: Perturbation Induced Step training

Voluntary Step training

ACTIVE COMPARATOR

Participants will receive 18 sessions over 6 weeks.

Other: Voluntary step training

Interventions

Perturbation Induced Step training OTHER

A sudden lateral displacement of the treadmill.

Perturbation induced step training

Voluntary step training OTHER

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

Voluntary Step training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vicki Gray: lead

Study Sites (1)

University of Maryland Baltimore

Baltimore, MD, Maryland, 21210, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2014
• Primary Completion: September 30, 2017
• Study Completion: March 30, 2018
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)