NCT07759063

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

August 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 5, 2026

Last Update Submit

August 10, 2026

Conditions

StrokeTraumatic Brain Injury

Keywords

gaithemiparesisphysical therapywalking

Outcome Measures

Primary Outcomes (2)

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

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

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

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

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

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

Study Arms (2)

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

EXPERIMENTAL
Behavioral: Walking on self-pacing treadmillBehavioral: Walking on fixed-pacing treadmill

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

EXPERIMENTAL
Behavioral: Walking on self-pacing treadmillBehavioral: Walking on fixed-pacing treadmill

Interventions

Walking on self-pacing treadmillBEHAVIORAL

Contrast with walking on fixed-pacing treadmill.

Fixed-pacing treadmill walking first, then self-pacing treadmill walkingSelf-pacing treadmill walking first, then fixed-pacing treadmill walking
Walking on fixed-pacing treadmillBEHAVIORAL

Contrast with walking on self-pacing treadmill.

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

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current client of Quality Living, Inc., in Omaha, NE
  • 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

You may not qualify if:

  • Has not retained power of attorney for healthcare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

StrokeBrain Injuries, TraumaticParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karen Hux, Ph.D.

    Quality Living, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 11, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Individual participant data will be available in deidentified form from the principal investigator.

Shared Documents
STUDY PROTOCOL, CSR

Locations

US(1)