Post-stroke Perturbation Training

NCT04855032 | Completed DMC

• 2 other identifiers: 001018101R01HD103923-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fall incidence

  A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.

  32 weeks (12-week period pre-intervention; 12-week period post-intervention)

Secondary Outcomes (14)

• Fear of falling

  8 weeks (pre-intervention; post-intervention)

• Functional Gait Assessment

  8 weeks (pre-intervention; post-intervention)

• Activities-specific Balance Confidence scale

  8 weeks (pre-intervention; post-intervention)

• Walking speed

  8 weeks (pre-intervention; post-intervention)

• Foot placement stabilization strategy (mechanics)

  8 weeks (pre-intervention; post-intervention)

Study Arms (2)

Reactive Perturbations

EXPERIMENTAL

Behavioral: Reactive Perturbations

Proactive Perturbations

EXPERIMENTAL

Behavioral: Proactive Perturbations

Interventions

Reactive Perturbations BEHAVIORAL

A novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered.

Reactive Perturbations

Proactive Perturbations BEHAVIORAL

A novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device.

Proactive Perturbations

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience of a stroke at least 6 months prior to participation
• Self-reported experience of a fall in the previous year, and/or a fear of falling
• Gait speed of at least 0.2 m/s
• Ability to walk on a treadmill without a cane or walker
• Provision of informed consent

You may not qualify if:

• Evidence of cerebellar damage
• Resting blood pressure higher than 220/110 mm Hg
• History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
• Preexisting neurological disorders or dementia
• Legal blindness or severe visual impairment
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jesse Dean

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 22, 2021
• Study Start: October 6, 2021
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be shared once the primary publication generated from this study has been published.
• Access Criteria: No restrictions will be placed on the use of the data to be shared.

Locations

US (1)