Reducing Asymmetry During Gait Using the TPAD (Tethered Pelvic Assist Device) for Stroke Patients

Completed · Not applicable

Conditions studied: Stroke

In brief

OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of safety, treatment tolerance and adherence as well as preliminarily address how effective this treatment model using the TPAD and overground training would be to reduce load asymmetry on the treadmill and promote increased stance symmetry on the paretic limb during overground gait.PARTICIPANTS: A total of 12 individuals in the chronic (\>6 months) stages post stroke will be recruited from a voluntary stroke research database for participation. DESIGN: A non-randomized pilot study of feasibility will be used to establish the feasibility and preliminary efficacy of using the TPAD in combination with overground training to reduce load force asymmetry in this population. METHODS: Participants will undergo a series of three assessments within a one-week time frame prior to initiating intervention. Intervention using the TPAD and overground training will occur during week 2 over 5 consecutive visits (Mon-Fri). Participants will also complete short walks before and after the intervention with an instrumented system that records individual walking characteristics. Participants will return one-week after completing the intervention for a final test of walking and balance. Each study visit will be approximately 1-1.5 hours in duration, and total participation should be completed within three weeks. EXPECTED OUTCOMES: We anticipate this training paradigm will prove feasible and effective in reducing both load and stance asymmetry in a population of individuals with chronic stroke.

Key facts

Study ID

NCT03203291

Run by

Columbia University

People needed

12

Starts

2017-04-01

Expected to finish

2018-05-01

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic (>6 months) post stroke
• Single stroke event
• Montreal Cognitive Assessment (MoCA) score of >22
• Independently ambulating in the home
• Use of a unilateral assistive device (e.g. cane)
• Marked asymmetry in stance phase (defined by a symmetry ratio < 0.90)

You may not qualify if…

• History of multiple strokes
• History of other neurological disease
• Uncontrolled medical issues
• Muscle contractures of the lower limb limiting range of motion

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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