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Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery (BLT2)

Primary Purpose

Stroke, Chronic Stroke, Walking, Difficulty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Backward Locomotion Treadmill Training (BLTT)
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
  • Ability to maintain ≥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:

  • Walking speed <0.4m/s (per 10MWT comfortable)
  • 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 Medicine

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 3 weeks.

Participants train on a treadmill (no bodyweight support), three times per week x 3 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)
wo 10MWT trials (using a stop-watch) are averaged and documented in meters/second.

Full Information

First Posted
September 6, 2020
Last Updated
September 11, 2023
Sponsor
University of Cincinnati
Collaborators
American Academy of Neurology
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1. Study Identification

Unique Protocol Identification Number
NCT04553198
Brief Title
Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
Acronym
BLT2
Official Title
Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
American Academy of Neurology

4. Oversight

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

5. Study Description

Brief Summary
Despite current walking rehabilitation strategies, the majority of stroke survivors are unable to walking independently in the community and remain at increased risk of falls. Backward treadmill training is a novel training approach used by elite athletes to enhance speed, agility, and balance; however, it is currently unknown how this exercise interacts with the central nervous system or if it could benefit stroke survivors with residual walking impairment. Knowledge gained from this study will likely lead to more effective walking rehabilitation strategies in stroke and related disorders.
Detailed Description
Walking impairment after a stroke impacts nearly 66% of stroke survivors and is a rising cause of morbidity worldwide. Despite ongoing efforts to increase the quality and delivery of rehabilitative care, less than ten percent of stroke survivors ever achieve walking independence within the community and are at higher risk of falls, fractures, rehospitalization. Several factors may lead to walking impairment, but the two most prevalent causes are lower extremity asymmetry and imbalance. Herein, the investigators propose backward locomotion treadmill training (BLTT), as a promising approach for walking rehabilitation in stroke survivors. Hence, our central hypothesis is that BLTT facilitates sensory signaling, leading to an improvement in walking speed. The investigators have preliminary proof of technique and feasibility data suggesting that BLTT is safe and feasible for stroke patients, with our results showing clinically meaningful improvement in overground walking speed after just six training sessions, with retention at the two-week follow-up. The next logical step in planning toward a future definitive clinical trial is to determine its preliminary efficacy compared with conventional forward walking treadmill training (FLTT) as control. The investigators plan to test the preliminary efficacy of BLTT by conducting a prospective, randomized, blinded-endpoint, pilot study of 40 individuals with residual mild-moderate gait impairment, >6 months post-stroke, to BLTT (n=20) versus FLTT (n=20), for nine 30-minute training session (3 sessions/week). The investigators will utilize well-validated behavioral measures in stroke recovery and rehabilitation to test the following Aims: Aim 1. Determine the training-related effects of BLTT on overground walking speed (primary outcome) To achieve this aim, the investigators will compare the Pre-Post change in walking speed [10- meter walk test (10MWT)] between groups. Our working hypothesis 1 is that BLTT will increase walking speed (>0.13m/s), compared to the control group (FLTT). Aim 2. Determine the effects of training on walking symmetry, proprioceptive signaling, and dynamic 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(b) and completion time on the i-TUG (c).

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
The outcomes assessor is blinded to the intervention type.
Allocation
Randomized
Enrollment
44 (Actual)

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 3 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 3 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Backward Locomotion Treadmill Training (BLTT)
Intervention Description
9-training sessions of reverse treadmill training (no bodyweight support)over three 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
wo 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
Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
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 Ability to maintain ≥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: Walking speed <0.4m/s (per 10MWT comfortable) 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).
Facility Information:
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery

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