Post-stroke Perturbation Training

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Behavioral: Reactive Perturbations; Behavioral: Proactive Perturbations

• Registration Number: NCT04855032
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-17
• Study First Submitted QC: 2021-04-17
• Study First Posted: 2021-04-22
• Study Start: 2021-10-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reactive Perturbations	Reactive Perturbations	-
Proactive Perturbations	Proactive Perturbations	-

Primary Outcome Measures

Name	Time	Method
Fall incidence	32 weeks (12-week period pre-intervention; 12-week period post-intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Activities-specific Balance Confidence scale	8 weeks (pre-intervention; post-intervention)	A common clinical measure of balance self-efficacy
Foot placement stabilization strategy (gluteus medius activity)	8 weeks (pre-intervention; post-intervention)	We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of gluteus medius activity during the first half of the swing phase, accounting for pelvis velocity.
Functional Gait Assessment	8 weeks (pre-intervention; post-intervention)	A common clinical measure of gait balance
Walking speed	8 weeks (pre-intervention; post-intervention)	Participants will be instructed to walk overground along a 10-meter path at the speed they would normally use around their house of the store. Speed will be measured for the middle 6-meters of the path.
Fear of falling	8 weeks (pre-intervention; post-intervention)	Participants will be asked if they have a fear of falling (yes/no).
Push-off stabilization strategy (mechanics)	8 weeks (pre-intervention; post-intervention)	We will calculate the partial correlation between the pelvis displacement at the start of each step, and the time integral of the total ground reaction force under the trail leg during the double support phase preceding this step, accounting for pelvis velocity.
Push-off stabilization strategy (medial gastrocnemius activity)	8 weeks (pre-intervention; post-intervention)	We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of medial gastrocnemius activity during the double support phase preceding this step, accounting for pelvis velocity.
Center of pressure shift stabilization strategy (mechanics)	8 weeks (pre-intervention; post-intervention)	We will calculate the partial correlation between the pelvis velocity at the start of each step, and the magnitude of the change in mediolateral center of pressure location under the stance foot during the step, accounting for pelvis displacement.
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)	8 weeks (pre-intervention; post-intervention)	We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)	8 weeks (pre-intervention; post-intervention)	We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Foot placement stabilization strategy (mechanics)	8 weeks (pre-intervention; post-intervention)	We will calculate the partial correlation between the pelvis displacement at the start of each step, and step width at the end of the step, accounting for pelvis velocity.
Center of pressure shift stabilization strategy (peroneus longus activity)	8 weeks (pre-intervention; post-intervention)	We will calculate the partial correlation between the pelvis velocity at the start of each step, and the mean magnitude of peroneus longus muscle activity during the single support stance phase of this step, accounting for pelvis displacement.
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)	8 weeks (pre-intervention; post-intervention)	We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)	8 weeks (pre-intervention; post-intervention)	We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States