NCT06866353

Brief Summary

The purpose of this research study is to determine the effect of various assistive devices on gait quality and balance for individuals with cerebellar ataxia. You are being asked to be a participant in this study because your balance and walking function have been impacted by cerebellar ataxia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 28, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

March 4, 2025

Results QC Date

July 22, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

ataxiagaitbalanceassistive device

Outcome Measures

Primary Outcomes (1)

  • Zeno Walkway - Gait Speed

    The Zeno provides kinematic gait information including gait velocity.

    Day one

Other Outcomes (1)

  • Dynamic Gait Index (4 Items)

    Day One

Study Arms (1)

Gait with Walker

EXPERIMENTAL

Individuals with ataxia

Device: Walking with different walkers

Interventions

Participants will walk across a computerized pressure sensor mat and complete a dynamic walking test with several different assistive devices (rolling walker, rollator with platform, and a gait trainer) and potentially with a metronome. During all testing, study physical therapists will guard participants to assure safety. In total, the study will require 1 visit to the School of Health Professions for 1-2 hours

Gait with Walker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cerebellar ataxia,
  • gait impairment (gait velocity \</= 110 cm/sec without an assistive device),
  • ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s), 18 years or older

You may not qualify if:

  • Gait velocity \>/= 110 cm/sec without an assistive device,
  • Medically diagnosed orthopedic conditions or injuries that impact ambulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75220, United States

Location

Related Publications (1)

  • Buckley E, Mazza C, McNeill A. A systematic review of the gait characteristics associated with Cerebellar Ataxia. Gait Posture. 2018 Feb;60:154-163. doi: 10.1016/j.gaitpost.2017.11.024. Epub 2017 Dec 1.

    PMID: 29220753BACKGROUND

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Staci Shearin
Organization
The University of Texas Southwestern Medical Center

Study Officials

  • Staci M Shearin, PhD

    UTSW

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

May 22, 2025

Primary Completion

September 6, 2025

Study Completion

September 6, 2025

Last Updated

September 28, 2026

Results First Posted

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations