Optimizing Training in Severe Post-Stroke Walking Impairment

NCT04721860 | Completed

• 1 other identifier: 2020-0784
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

  Temporal Symmetry Index

• 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

Study Arms (2)

Backward Locomotion Treadmill Training (BLTT)

EXPERIMENTAL

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

Behavioral: Forward Locomotion Treadmill Training (FLTT)

Interventions

Backward Locomotion Treadmill Training (BLTT) BEHAVIORAL

12-training sessions of reverse treadmill training (no bodyweight support) over four weeks.

Backward Locomotion Treadmill Training (BLTT)

Forward Locomotion Treadmill Training (FLTT) BEHAVIORAL

12-training sessions of forward treadmill training (no bodyweight support) over tfour weeks.

Forward Locomotion Treadmill Training (FLTT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Stroke; Mobility Limitation; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stratified Randomization

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: October 15, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)