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

September 11, 2023 updated by: Oluwole Awosika, University of Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Backward Locomotion Treadmill Training (BLTT)
Participants train on a reverse treadmill (no bodyweight support), three times per week x 3 weeks.
Behavioral: Backward Locomotion Treadmill Training (BLTT)
9-training sessions of reverse treadmill training (no bodyweight support)over three weeks.
Sham Comparator: Forward Locomotion Treadmill Training (FLTT)
Participants train on a treadmill (no bodyweight support), three times per week x 3 weeks.
Behavioral: Backward Locomotion Treadmill Training (BLTT)
9-training sessions of reverse treadmill training (no bodyweight support)over three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 10-Meter Walk (fast)
Time Frame: Pre-Baseline (Day of Randomization) to One Day Post-Training
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
Pre-Baseline (Day of Randomization) to One Day Post-Training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-Meter Walk Test (Fast- Retention)
Time Frame: One Day Post Training, One month Post Training, 3- Months Post Training
Two 10MWT (fast) trials (using a stop-watch) are averaged and documented in meters/second.
One Day Post Training, One month Post Training, 3- Months Post Training
10-Meter Walk (Comfortable)
Time Frame: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training
wo 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporal Symmetry Index
Time Frame: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
%-limb support of the affected and unaffected leg, during the 10 MWT
Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
Static Balance: Sway Index (SI)
Time Frame: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
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.
Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 3 Meter
Time Frame: Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training
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.
Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training
Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 7 Meter
Time Frame: Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training
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.
Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

American Academy of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

January 3, 2023

Study Completion (Actual)

January 3, 2023

Study Registration Dates

First Submitted

September 6, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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