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Optimizing Training in Severe Post-Stroke Walking Impairment (BLT2b)

Primary Purpose

Stroke, Chronic Stroke, Walking, Difficulty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Backward Locomotion Treadmill Training (BLTT)
Forward Locomotion Treadmill Training (FLTT)
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Gait, Balance, Non-body weight supported treadmill training, Backward locomotion treadmill training, Forward locomotion treadmill training, Walking Rehabilitation, Walking Recovery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years of age
  • Walking speed less than or equal to 0.4 meters/second
  • Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill
  • Able to walk independently (cane and hemi-walker acceptable)
  • Ambulate >10 meters over ground with the Free Step Harness System (as a safety precaution)
  • Discharged from formal rehabilitation

Exclusion Criteria:

  • Unstable cardiac status which would preclude participation in a moderate-intensity exercise program.
  • Significant language barrier which might prevent the participant from following instructions during training and testing.
  • Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect)
  • Severe lower extremity spasticity (Ashworth >2)
  • Depression (>10 on the Patient Health Questionnaire, if untreated).

Sites / Locations

  • University of Cincinnati College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Backward Locomotion Treadmill Training (BLTT)

Forward Locomotion Treadmill Training (FLTT)

Arm Description

Participants train on a reverse treadmill (no bodyweight support), three times per week x 4 weeks.

Participants train on a treadmill (no bodyweight support), three times per week x 4 weeks.

Outcomes

Primary Outcome Measures

Change in 10-Meter Walk (fast)
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.

Secondary Outcome Measures

10-Meter Walk Test (Fast- Retention)
Two 10MWT (fast) trials (using a stop-watch) are averaged and documented in meters/second.
10-Meter Walk (Comfortable)
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.

Full Information

First Posted
January 19, 2021
Last Updated
September 11, 2023
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04721860
Brief Title
Optimizing Training in Severe Post-Stroke Walking Impairment
Acronym
BLT2b
Official Title
Optimizing Training in Severe Post-Stroke Walking Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

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

5. Study Description

Brief Summary
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
Detailed Description
Severe walking impairment after stroke is defined as the inability to walk faster than 0.4 meters per second and impacts nearly twenty-five percent of chronic stroke survivors. Walking speed is a key determiner of community independence, and stroke survivors classified as "severe" are more often symptomatically home-bound with limited mobility and are at higher risk of falls, fractures, and rehospitalizations. A recent study by the investigators suggests that backward locomotion treadmill training (BLTT) may be a promising rehabilitative approach in stroke survivors with severe walking impairment; however, the effect of training duration on behavioral outcomes is unknown. The objective of this study is to obtain critical pilot data on the effects of extended BLTT on walking speed, symmetry, and balance (static and dynamic), in chronic stroke survivors with baseline severe walking impairment, relative to forward treadmill training controls (FLTT). Aim 1. Determine the training-related effects of extended BLTT on overground walking speed (primary outcome) in survivors with severe walking impairment. To achieve this aim, we will compare the Pre-Post change in walking speed [10- meter walk test (10MWT)] between groups. The working hypothesis is that extended BLTT will increase walking speed to a clinically meaningful level (≥0.16m/s), compared to the control group (FLTT). Aim 2. Determine the effects of extended BLTT on walking symmetry and balance. The Zeno Walkway Gait Analysis software will capture Pre-Post changes in temporal gait symmetry index during the 10-MWT. Working hypothesis 2a: BLTT will be associated with a favorable improvement in the temporal symmetry index score. Proprioception and spinovestibular function will be measured with the modified Sensorineural Integration Test (mSIT), and dynamic balance will be assessed with the completion time on the instrumented Timed Up & Go (i- TUG). Working hypothesis 2b and c: BLTT will be associated with a favorable improvement Pre-Post mSIT(a) and completion time on the i-TUG (b).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chronic Stroke, Walking, Difficulty, Gait, Hemiplegic
Keywords
Gait, Balance, Non-body weight supported treadmill training, Backward locomotion treadmill training, Forward locomotion treadmill training, Walking Rehabilitation, Walking Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stratified Randomization
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Backward Locomotion Treadmill Training (BLTT)
Arm Type
Experimental
Arm Description
Participants train on a reverse treadmill (no bodyweight support), three times per week x 4 weeks.
Arm Title
Forward Locomotion Treadmill Training (FLTT)
Arm Type
Sham Comparator
Arm Description
Participants train on a treadmill (no bodyweight support), three times per week x 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Backward Locomotion Treadmill Training (BLTT)
Intervention Description
12-training sessions of reverse treadmill training (no bodyweight support) over four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Forward Locomotion Treadmill Training (FLTT)
Intervention Description
12-training sessions of forward treadmill training (no bodyweight support) over tfour weeks.
Primary Outcome Measure Information:
Title
Change in 10-Meter Walk (fast)
Description
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
Time Frame
Pre-Baseline (Day of Randomization) to One Day Post-Training
Secondary Outcome Measure Information:
Title
10-Meter Walk Test (Fast- Retention)
Description
Two 10MWT (fast) trials (using a stop-watch) are averaged and documented in meters/second.
Time Frame
One Day Post Training, One month Post Training, 3- Months Post Training
Title
10-Meter Walk (Comfortable)
Description
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
Time Frame
Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training
Other Pre-specified Outcome Measures:
Title
Temporal Symmetry Index
Description
%-limb support of the affected and unaffected leg, during the 10 MWT
Time Frame
Temporal Symmetry Index
Title
Static Balance: Sway Index (SI)
Description
The Biodex Modified Clinical Test of Sensory Interaction on Balance (mSIBT) is a well-validated balance system and has been used neurally intact and neurologically impaired individuals to objectively measure static balance. Compared to other measures of static balance, the mSIBT provides the added benefit of differentiating the contributions of the visual, proprioceptive and vestibular systems. Method: While on the platform (with safety harness), participants will stand with the hands at the side under 4 conditions (30 secs/condition):1) firm surface with the eyes open, 2) firm surface with the eyes closed, 3) compliant surface (foam) with the eyes open, 4) Compliant surface (foam) with the eyes closed. Three attempts will be average and documented as SI.
Time Frame
Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
Title
Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 3 Meter
Description
Participants will be instructed to sit with the back against the chair (seat height 46cm, arm height 67cm) and on the word "go," stand up, walk at a comfortable speed past the 3-m mark, turn around, walk back, and sit down in the chair. Two trials are averaged and documented in seconds.
Time Frame
Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training
Title
Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 7 Meter
Description
Participants will be instructed to sit with the back against the chair (seat height 46cm, arm height 67cm) and on the word "go," stand up, walk at a comfortable speed past the 7-m mark, turn around, walk back, and sit down in the chair. Two trials are averaged and documented in seconds.
Time Frame
Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years of age Walking speed less than or equal to 0.4 meters/second Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill Able to walk independently (cane and hemi-walker acceptable) Ambulate >10 meters over ground with the Free Step Harness System (as a safety precaution) Discharged from formal rehabilitation Exclusion Criteria: Unstable cardiac status which would preclude participation in a moderate-intensity exercise program. Significant language barrier which might prevent the participant from following instructions during training and testing. Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect) Severe lower extremity spasticity (Ashworth >2) Depression (>10 on the Patient Health Questionnaire, if untreated).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oluwole O Awosika, MD,MSCR
Phone
513-558-0225
Email
oluwole.awosika@uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Colin Drury, MS
Phone
513-558-7487
Email
drurycd@ucmail.uc.edu
Facility Information:
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oluwole O Awosika, MD,MSCR
Phone
310-386-0149
Email
oluwole.awosika@uc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Training in Severe Post-Stroke Walking Impairment

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