Treadmill Oscillation Walking to Improve Weight Transfer During Gait Following Stroke

NCT05541705 | Recruiting

• 1 other identifier: STUDY00002635
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait characteristics in individuals post-stroke. It was hypothesized that compared to baseline, individuals poststroke (N=15) will show increased hip abductor and knee extensor muscle activity and torque production, and increased limb loading and walking speeds during TOW and following a 6-week TOW intervention, reflecting that TOW can enhance gait function through improved hip and knee neuromechanical activation.

Conditions

Treadmill Walking

Outcome Measures

Primary Outcomes (3)

• VGRF

  changes in peak vertical ground reaction force from pre-training to post-training and month follow-up will be calculated

  pre-training, within one week after training completion, 1 month follow-up

• Walking speed

  changes in self-selected walking speed from pre-training to post-training and month follow-up will be calculated

  pre-training, within one week after training completion, 1 month follow-up

• Self-efficacy

  changes in self-perceived balance and mobility ability from pre-training to post-training and month follow-up will be calculated

  pre-training, within one week after training completion, 1 month follow-up

Study Arms (1)

TOW

EXPERIMENTAL

Treadmill Oscillation Walking training

Behavioral: Treadmill Oscillation Walking

Interventions

Treadmill Oscillation Walking BEHAVIORAL

Each participant with stroke will partake in 18 training sessions. Training sessions will be for one hour three times a week for 6 weeks. During training, participants will walk at their self-selected walking speed on the treadmill that moves side-to-side for 1 cm in a sinusoidal pattern. The sinusoidal oscillation frequency will match each participant's natural stride frequency calculated from baseline evaluation. Subjects will be instructed to respond naturally and maintain continuous walking. Participants will wear a safety harness with no body weight support. For each training session, six 6-minute bouts of treadmill oscillation trials will be performed (Hsiao et al. 2016) and rest period will be provided between bouts. Because lower extremity muscle activity increases with increasing oscillation frequency, the treadmill oscillation frequency will be increased by 5% each week to continue to drive progressive adaptive changes (25% over 6 weeks) (Pohl et al. 2002).

TOW

Eligibility Criteria

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

You may qualify if:

• Hemiparesis as a result of a stroke greater than 6 months previous to the study;
• A single cortical or subcortical stroke
• Able to walk 10 meters with or without a walking aid
• Able to stand unsupported for 5 minutes
• Sufficient cognitive function to follow instruction and communicate with the investigators.
• Reduced paretic limb loading more than 6% compared to the non-paretic limb during overground gait assessment

You may not qualify if:

• Medical condition precluding participant in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies;
• Bilateral stroke or a previous stroke in the contralateral hemisphere;
• Had a history of multiple strokes;
• Cerebellar stroke;
• Lower extremity joint replacement;
• Bone or joint problems that limited their ability to walk;
• A resting heart rate outside of the range of 40 to 100 beats per minute;
• A resting blood pressure outside of the range of 90/60 to 170/90 mm Hg;
• Neglect;
• Hemianopia;
• Unexplained dizziness during the past 6 months;
• Chest pain or shortness of breath without exertion;
• Pregnancy by self-report.

Sponsors & Collaborators

• University of Texas at Austin: lead
• University of Maryland, Baltimore: collaborator
• Texas State University: collaborator

Study Sites (1)

Bellmont Hall

Austin, Texas, 78712, United States

RECRUITING

Related Publications (3)

• Johnson ME, Mille ML, Martinez KM, Crombie G, Rogers MW. Age-related changes in hip abductor and adductor joint torques. Arch Phys Med Rehabil. 2004 Apr;85(4):593-7. doi: 10.1016/j.apmr.2003.07.022.

  PMID: 15083435 BACKGROUND

• Hsiao H, Awad LN, Palmer JA, Higginson JS, Binder-Macleod SA. Contribution of Paretic and Nonparetic Limb Peak Propulsive Forces to Changes in Walking Speed in Individuals Poststroke. Neurorehabil Neural Repair. 2016 Sep;30(8):743-52. doi: 10.1177/1545968315624780. Epub 2015 Dec 31.

  PMID: 26721869 BACKGROUND

• Pohl M, Mehrholz J, Ritschel C, Ruckriem S. Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Stroke. 2002 Feb;33(2):553-8. doi: 10.1161/hs0202.102365.

  PMID: 11823669 BACKGROUND

Central Study Contacts

Hao-Yuan Hsiao, PhD

CONTACT

5122321782; hhsiao@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 15, 2022
• Study Start: December 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available following the completion of data analyses for 10 years.

Locations

US (1)