NCT04553198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

September 6, 2020

Last Update Submit

September 11, 2023

Conditions

StrokeChronic StrokeWalking, DifficultyGait, Hemiplegic

Keywords

GaitBalanceNon-body weight supported treadmill trainingBackward locomotion treadmill trainingForward locomotion treadmill trainingWalking RehabilitationWalking Recovery

Outcome Measures

Primary Outcomes (1)

  • Change in 10-Meter Walk (fast)

    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 Outcomes (2)

  • 10-Meter Walk Test (Fast- Retention)

    One Day Post Training, One month Post Training, 3- Months Post Training

  • 10-Meter Walk (Comfortable)

    Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training

Other Outcomes (4)

  • Temporal Symmetry Index

    Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training

  • Static Balance: Sway Index (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

    Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training

  • +1 more other outcomes

Study Arms (2)

Backward Locomotion Treadmill Training (BLTT)

EXPERIMENTAL

Participants train on a reverse treadmill (no bodyweight support), three times per week x 3 weeks.

Behavioral: Backward Locomotion Treadmill Training (BLTT)

Forward Locomotion Treadmill Training (FLTT)

SHAM COMPARATOR

Participants train on a treadmill (no bodyweight support), three times per week x 3 weeks.

Behavioral: Backward Locomotion Treadmill Training (BLTT)

Interventions

Backward Locomotion Treadmill Training (BLTT)BEHAVIORAL

9-training sessions of reverse treadmill training (no bodyweight support)over three weeks.

Backward Locomotion Treadmill Training (BLTT)Forward Locomotion Treadmill Training (FLTT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

StrokeMobility LimitationGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor is blinded to the intervention type.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: stratified randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSCR

Study Record Dates

First Submitted

September 6, 2020

First Posted

September 17, 2020

Study Start

September 1, 2020

Primary Completion

January 3, 2023

Study Completion

January 3, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)