NCT04855032

Post-stroke Perturbation Training

Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People With Chronic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Reactive Perturbations	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.
BEHAVIORAL	Proactive Perturbations	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.

Timeline

• Start date: 2021-10-06
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2021-04-22
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States