search
Back to results

Perturbation Training for Fall-risk Reduction Among Stroke Survivors

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Overground slip perturbation training
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Fall risk, Stroke survivors, Perturbation training

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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%

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Slip training for chronic stroke

Control for chronic stroke

Slip training for sub-acute stroke

Control for sub-acute stroke

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Stability
Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity.
Change in Limb support
The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall.
Change in gait speed
Gait speed will be computed from an average of three walking trials on the laboratory walkway.
Change in symmetry
Symmetry will be computed from an average of three walking trials on the laboratory walkway.
Change in gait speed during functional ambulation
The gait speed for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in ambulatory skills of the patient and decrease reliance on the assistive device.
Change in physical activity
The total number of steps and distance for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in physical activity of the patient and decrease reliance on the assistive device.

Full Information

First Posted
June 23, 2017
Last Updated
July 8, 2021
Sponsor
University of Illinois at Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03205527
Brief Title
Perturbation Training for Fall-risk Reduction Among Stroke Survivors
Official Title
Perturbation Training for Enhancing Stability and Limb Support Control for Fall-risk Reduction Among Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Approximately 800,000 Americans suffer a stroke every year and 689,450 reported having short and long-term disabilities leading to dependence in activities of daily living. It has been reported that stroke survivors experienced detrimental falls each year and most occurring during walking. The likelihood of experiencing a fall upon discharge from rehabilitation being significantly higher than during the rehabilitative phase. Falls resulting from environmental perturbations such as slips contribute to a significant percentage of these falls. Hence, it is important to develop innovative and effective paradigms for fall-risk reduction in chronic as well as sub-acute stroke survivors. The purpose of this research is to understand the effect of bilateral slip-perturbation training protocol targeting training both paretic vs. non-paretic limbs on fall-risk reduction and prevention. Also, to find its effect on increasing community ambulation in community dwelling stroke survivors. Participants in this study will be individuals with chronic (> 6 months) hemiparesis following stroke or individuals with sub-acute stroke (> 6weeks and < 6 months), ambulatory (with or without assistive device) and more than 21 years of age. Subjects will be screened for the inclusion criteria. If subjects pass the screening, they will go through the full clinical balance assessment and laboratory dynamic stability test. The chronic stroke survivors will be randomized into two groups: - Group A: Slip training group; Group B: Control group. While, the sub-acute stroke survivors will be randomized into two groups: - Group C: Slip training group; Group D: Control group. For the slip training groups (A and C), all subjects' normal walking pattern and their recovery responses to slip will be recorded with a motion tracking system (including videotaping) while they walk across an instrumented area along a straight path in the lab. A slip will be induced after a subject steps on a low-friction platform. For the chronic stroke subjects, baseline activity monitoring using wearable sensors will be performed for up to four weeks prior to the training session followed by activity monitoring for 12 months. While for the sub-acute stroke subjects, it would be done for 6 months. For groups A and B, the follow-up stability test will be at 6 and 12 months post-training session, which will consist only of one slip induced on the training side and contralateral side. For groups C and D, follow-up session is 6 months post training session. Incidence of falls and physical activity will be monitored between training and re-test sessions through falls, activity monitoring-questionnaire to describe details of the falls and through the wearable sensors for groups A, B, C and D.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Fall risk, Stroke survivors, Perturbation training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Slip training for chronic stroke
Arm Type
Experimental
Arm Description
Chronic stroke subjects in this training group will receive bilateral overground, slip perturbation training.
Arm Title
Control for chronic stroke
Arm Type
No Intervention
Arm Description
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.
Arm Title
Slip training for sub-acute stroke
Arm Type
Experimental
Arm Description
Sub-acute stroke survivors in this training group will receive bilateral overground, slip perturbation training.
Arm Title
Control for sub-acute stroke
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Overground slip perturbation training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in laboratory induced falls
Description
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.
Time Frame
Pre-training, immediate post-training, 6-month post training, 12-month post training
Title
Change in real life falls
Description
Real life falls are measured to determine if training effect can be translated into everyday real life setting.
Time Frame
Retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary
Secondary Outcome Measure Information:
Title
Change in Stability
Description
Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity.
Time Frame
Pre-training, immediate post-training, 6-month post training, 12-month post training
Title
Change in Limb support
Description
The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall.
Time Frame
Pre-training, immediate post-training, 6-month post training, 12-month post training
Title
Change in gait speed
Description
Gait speed will be computed from an average of three walking trials on the laboratory walkway.
Time Frame
Pre-training, 6-month post training, 12-month post training
Title
Change in symmetry
Description
Symmetry will be computed from an average of three walking trials on the laboratory walkway.
Time Frame
Pre-training, 6-month post training, 12-month post training
Title
Change in gait speed during functional ambulation
Description
The gait speed for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in ambulatory skills of the patient and decrease reliance on the assistive device.
Time Frame
One month before pretest till prospectively 12 months post training
Title
Change in physical activity
Description
The total number of steps and distance for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in physical activity of the patient and decrease reliance on the assistive device.
Time Frame
One month before pretest till prospectively 12 months post training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shamali Dusane, MPT
Phone
3123552735
Email
sdusan2@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yiru Wang, MS PT
Phone
3123553988
Email
ywang327@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanvi Bhatt, PhD PT
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamali Dusane, MPT
Phone
312-355-2735
Email
sdusan2@uic.edu
First Name & Middle Initial & Last Name & Degree
Yiru Wang, MS PT
Phone
3123553988
Email
ywang327@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35106605
Citation
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.
Results Reference
derived
PubMed Identifier
32815890
Citation
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.
Results Reference
derived

Learn more about this trial

Perturbation Training for Fall-risk Reduction Among Stroke Survivors

We'll reach out to this number within 24 hrs