Post-stroke Perturbation Training

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04855032

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arms

49.8

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Reactive Perturbations Behavioral: Proactive Perturbations	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 6, 2021

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reactive Perturbations	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.
Experimental: Proactive Perturbations	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.

Arm

Intervention/Treatment

Experimental: Reactive Perturbations

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.

Experimental: Proactive Perturbations

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.

Outcome Measures

Primary Outcome Measures

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

Fear of falling [8 weeks (pre-intervention; post-intervention)]
Participants will be asked if they have a fear of falling (yes/no).
Functional Gait Assessment [8 weeks (pre-intervention; post-intervention)]
A common clinical measure of gait balance
Activities-specific Balance Confidence scale [8 weeks (pre-intervention; post-intervention)]
A common clinical measure of balance self-efficacy
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.
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.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jesse Dean, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jesse Dean, PhD, Associate Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT04855032

Other Study ID Numbers:

00101810
1R01HD103923-01

First Posted:

Apr 22, 2021

Last Update Posted:

Mar 14, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Mar 14, 2022