Perturbation Training for Fall-risk Reduction Among Stroke Survivors

NCT03205527 | Active Not Recruiting DMC

• 2 other identifiers: 2016-09331R01HD088543-01A1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term objective of this research is to develop an efficacious training paradigm to enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times higher risk of hip fracture than their healthy counterparts; with only less than 40% of those individuals regaining independent mobility. Falls, thus not only affect activities of daily living but also reduce mobility, increase risk of second stroke and mortality. Despite potential financial and functional implications of falls in this population, health-care personnel are limited in their ability to develop and validate interventions to reduce fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing paretic limb function. The project design consists of a randomized controlled trial to examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations to slip-perturbation training for not only mitigating fall risk but also improving walking function. It also explores translation of this paradigm to the sub-acute population. The paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on fall-risk through a bilateral training paradigm that involves training the non-paretic side first and then paretic to facilitate acquisition of fall-prevention skills on the paretic side, which may otherwise take longer to acquire training effects. The longer-term benefits of such perturbation training, targeting both limbs for reducing falls will be assessed not only in the laboratory but also in real life via wearable sensors, along with improved community walking function. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk not only in people living with hemiparetic stroke but also among survivors of other acquired unilateral cortical lesions.

Conditions

Stroke

Keywords

Fall risk; Stroke survivors; Perturbation training

Outcome Measures

Primary Outcomes (2)

• Change in laboratory induced falls

  Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by amount of force recorded on the load cell attached to the ceiling mounted safety harness system donned by the participant. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90\~100% of subsequent falls (occurring \~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings.

  Pre-training, immediate post-training, 6-month post training, 12-month post training

• Change in real life falls

  Real life falls are measured to determine if training effect can be translated into everyday real life setting.

  Retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary

Secondary Outcomes (6)

• Change in Stability

  Pre-training, immediate post-training, 6-month post training, 12-month post training

• Change in Limb support

  Pre-training, immediate post-training, 6-month post training, 12-month post training

• Change in gait speed

  Pre-training, 6-month post training, 12-month post training

• Change in symmetry

  Pre-training, 6-month post training, 12-month post training

• Change in gait speed during functional ambulation

  One month before pretest till prospectively 12 months post training

Study Arms (4)

Slip training for chronic stroke

EXPERIMENTAL

Chronic stroke subjects in this training group will receive bilateral overground, slip perturbation training.

Other: Overground slip perturbation training

Control for chronic stroke

NO INTERVENTION

Chronic stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides.

Slip training for sub-acute stroke

EXPERIMENTAL

Sub-acute stroke survivors in this training group will receive bilateral overground, slip perturbation training.

Other: Overground slip perturbation training

Control for sub-acute stroke

NO INTERVENTION

Sub-acute stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides.

Interventions

Overground slip perturbation training OTHER

Slips will be induced by a low-friction platform (65×30×0.6 cm, μ\<0.05) embedded side-by-side in the walking path, set nearly flush with the floor surround. The moveable platform, mounted on top of a pair of force platforms (AMTI, Newton, MA) for measuring ground reaction forces is firmly locked in a stationary position. An unannounced release occurs at heel strike of the perturbed, without the knowledge of subject, after which the platform is free to slide up to 150 cm. The mechanical release is controlled by the loading on the force platforms and the computer.

Slip training for chronic stroke; Slip training for sub-acute stroke

Eligibility Criteria

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

You may qualify if:

• Subjects will have to be ambulatory (with or without assistive device) with self-reported chronic (\> 6 months) stroke-induced hemiparesis confirmed by participants' physician and medically cleared. Evidence of unilateral brain lesion confirmed by an imaging study (e.g. CT or MRI).
• Subjects with no other acute and significant neurological, cardiopulmonary, musculoskeletal or systemic diagnosis or have undergone a recent major surgery (\<6 months) or hospitalization (\<3 months) and not on any sedative drugs
• Ability to walk at least 10m with or without assistive device which includes use of ankle orthosis or functional electrical stimulation devices (which is equivalent to having a score of\> 4, dependent supervision on Functional Ambulatory category scale)

You may not qualify if:

• Severe osteoporosis (Ultrasound score \< -2)
• Cognitive impairment (Mini Mental State Exam score\<25)
• Aphasia (\<71% on Mississippi Aphasia Screening Test)
• Severe depression ( \> 15 on Geriatric Depression Scale)
• Severe obesity (BMI \>35Kilogram/m2)
• Complains of shortness of breath, or uncontrolled pain (\> 3/10 on VAS), or if pulse oxygen drops \<92% on the 6 minute walk test (for endurance)
• Uncontrolled hypertension (resting systolic blood pressure \> 165 mmHg and/or diastolic blood pressure \> 110mmHg)
• Resting heart rate \> 85% of age-predicted maximal heart rate
• Resting oxygen saturation \<95%

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

• Bhatt T, Dusane S, Gangwani R, Wang S, Kannan L. Motor adaptation and immediate retention to overground gait-slip perturbation training in people with chronic stroke: an experimental trial with a comparison group. Front Sports Act Living. 2023 Sep 13;5:1195773. doi: 10.3389/fspor.2023.1195773. eCollection 2023.

  PMID: 37780126 DERIVED

• Dusane S, Bhatt T. Can prior exposure to repeated non-paretic slips improve reactive responses on novel paretic slips among people with chronic stroke? Exp Brain Res. 2022 Apr;240(4):1069-1080. doi: 10.1007/s00221-021-06300-8. Epub 2022 Feb 1.

  PMID: 35106605 DERIVED

• Gangwani R, Dusane S, Wang S, Kannan L, Wang E, Fung J, Bhatt T. Slip-Fall Predictors in Community-Dwelling, Ambulatory Stroke Survivors: A Cross-sectional Study. J Neurol Phys Ther. 2020 Oct;44(4):248-255. doi: 10.1097/NPT.0000000000000331.

  PMID: 32815890 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Tanvi Bhatt, PhD PT

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: July 2, 2017
• Study Start: April 26, 2017
• Primary Completion: April 15, 2024
• Study Completion: March 15, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)