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Clinical Trials/NCT07759063
NCT07759063Enrolling By InvitationNot Applicable

Clinical Validation of Self-Pacing Algorithms on Step Length Symmetry in Hemiplegic Populations

Quality Living, Inc.1 site in 1 country30 target enrollmentStarted: August 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
30
Locations
1
Primary Endpoint
Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking

Study Overview

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of self-pacing algorithms in promoting step-length equalization in people with weakness on one side of the body. The main question it aims to answer is:

• How does walking on a treadmill that uses self-pacing algorithms to adjust speed affect stride length in comparison to walking on a treadmill without self-pacing capability? Researchers will compare study participants to themselves when walking on a self-pacing treadmill compared to walking on a fixed-pacing treadmill to see if a difference exists in the equalization of left- and right-sided stride length.

Participants will walk for two minutes at a self-selected pace to warm up and establish a baseline walking speed. They will then walk for 1 - 3 minutes either on a self-pacing treadmill or a fixed-pacing treadmill. A 3-minute seated rest break will follow. Then participants will walk for another 1 - 3 minutes using the treadmill not used in the first walking trial.

Detailed Description

The chosen treadmill has self-pacing algorithms installed that adjust speed as a person walks. This allows a person to increase or decrease speed as desired throughout a walking session. Researchers have not yet determined the effect of using a self-pacing treadmill on left-right gait equalization among people with acquired hemiparesis secondary to stroke or traumatic brain injury. The researchers will compare measurement data captured by the system software when participants walk on the treadmill with the self-pacing feature turned on versus off. Each walking trial will last 1 - 3 minutes and will occur in a random order during a single research session. The randomization is to ensure that fatigue is not a factor when interpreting results.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Current client of Quality Living, Inc., in Omaha, NE
  • •19 to 75 years of age
  • •Speak and understand English
  • •Can ambulate overground for at least 10 minutes with or without use of aids
  • •Medically cleared for treadmill exercise
  • •Hemiparesis secondary to stroke or traumatic brain injury

Exclusion Criteria

  • •Has not retained power of attorney for healthcare

Arms & Interventions

Self-pacing treadmill walking first, then fixed-pacing treadmill walking

Experimental

Intervention: Walking on self-pacing treadmill (Behavioral)

Self-pacing treadmill walking first, then fixed-pacing treadmill walking

Experimental

Intervention: Walking on fixed-pacing treadmill (Behavioral)

Fixed-pacing treadmill walking first, then self-pacing treadmill walking

Experimental

Intervention: Walking on self-pacing treadmill (Behavioral)

Fixed-pacing treadmill walking first, then self-pacing treadmill walking

Experimental

Intervention: Walking on fixed-pacing treadmill (Behavioral)

Outcomes

Primary Outcomes

Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking

Time Frame: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill during a single experimental session.

Non-hemiparetic side step length minus hemiparetic side step length when walking on self-pacing versus fixed pacing treadmill.

Difference in step-length on hemiparetic and non-hemiparetic sides

Time Frame: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill.

Length of forward movement of each foot during each walking step as measured in centimeters.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karen Hux, Ph.D.

Director of Research

Quality Living, Inc.

Study Sites (1)

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