NCT06908135

Brief Summary

  • Study Purpose: The purpose of the study is to compare changes in activity levels and walking in people with Parkinson disease after an 8-week independent walking program with or without using walking poles.
  • Major parts of the Study: Before the walking program: You will wear an activity sensor on your upper leg for one week to track activity levels. Measurements will be taken of you while you are walking. If you are placed in the walking pole group, you will be trained on how to use walking poles. Independent walking program: You will be asked to walk at least 3 times each week for 8 weeks and keep a log of your walking. If you are in the walking pole group, you will walk with the poles. After the walking program: Your walking measurements will be collected as before the walking program. You will wear an activity sensor for one week.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
terminated

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 12, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 12, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

walkingphysical activitygaitarm swingNordic walking

Outcome Measures

Primary Outcomes (4)

  • Gait Characteristic - gait speed

    Gait characteristics collected on Zenomat walkway, including gait speed (m/s)

    Prior to initiation of 8 week walking program and immediately upon completion.

  • Gait Characteristic - step length

    Gait characteristics collected on Zenomat walkway, including step length (m)

    Prior to initiation of 8 week walking program and immediately upon completion.

  • Gait Characteristic - step symmetry

    Gait characteristics collected on Zenomat walkway, including step symmetry (symmetry index, %)

    Prior to initiation of 8 week walking program and immediately upon completion.

  • Gait Characteristic - gait variability

    Gait characteristics collected on Zenomat walkway, including gait variability (enhanced gait variability index)

    Prior to initiation of 8 week walking program and immediately upon completion.

Secondary Outcomes (11)

  • Physical Activity

    Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.

  • Physical Activity - daily steps

    Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.

  • Physical Activity - daily sit to stands

    Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.

  • Physical Activity - activity score

    Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.

  • Four Square Step Test

    Prior to initiation of 8 week walking program and immediately upon completion.

  • +6 more secondary outcomes

Study Arms (2)

Walking Poles

EXPERIMENTAL

Participants who will be using walking poles

Behavioral: Independent walking program using walking poles

No Walking Poles

ACTIVE COMPARATOR

Participants who will not be using walking poles

Behavioral: Independent walking program without walking poles

Interventions

Participants will independently walk at least 3 times a week for 8 weeks without walking poles

No Walking Poles

Participants will independently walk at least 3 times a week for 8 weeks using walking poles

Walking Poles

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Parkinson disease,
  • ability to walk independently with or without a cane,
  • receive medical clearance to participate in an independent walking,
  • English or Spanish language proficiency at 8th grade level.

You may not qualify if:

  • diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded),
  • use of walking poles during walking for exercise more than 4 times during the last year (hiking with poles permitted),
  • weight of more than 320 lb or height more than 6'4",
  • allergy to medical-grade adhesive,
  • unable to participate in walking for more than 5 consecutive days during the study period (ie, traveling, scheduled surgery),
  • a change in Parkinson medication that affects Levodopa levels (including additions, removals, or changes in dosage) during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Northwest University of Health Sciences

Yakima, Washington, 98901, United States

Location

Related Publications (4)

  • Warmerdam E, Romijnders R, Welzel J, Hansen C, Schmidt G, Maetzler W. Quantification of Arm Swing during Walking in Healthy Adults and Parkinson's Disease Patients: Wearable Sensor-Based Algorithm Development and Validation. Sensors (Basel). 2020 Oct 21;20(20):5963. doi: 10.3390/s20205963.

    PMID: 33096899BACKGROUND
  • Shearin SM, McCain KJ, Querry R. Description of novel instrumented analysis of the Four Square Step Test with clinical application: A pilot study. Gait Posture. 2020 Oct;82:14-19. doi: 10.1016/j.gaitpost.2020.08.119. Epub 2020 Aug 20.

    PMID: 32858317BACKGROUND
  • Salse-Batan J, Sanchez-Lastra MA, Suarez-Iglesias D, Varela S, Ayan C. Effects of Nordic walking in people with Parkinson's disease: A systematic review and meta-analysis. Health Soc Care Community. 2022 Sep;30(5):e1505-e1520. doi: 10.1111/hsc.13842. Epub 2022 May 20.

    PMID: 35593147BACKGROUND
  • Cugusi L. Nordic Walking for the Management of People With Parkinson Disease: A Systematic Review - ClinicalKey. Accessed July 9, 2024. https://www-clinicalkey-com.proxy.pnwu.org/#!/content/playContent/1-s2.0-S1934148217302897?returnurl=null&referrer=null

    BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Tiffany Salido, DPT, PhD

    Pacific Northwest University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center, two arm, pre-test post-test parallel design with 2 cohorts of participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

April 3, 2025

Study Start

March 29, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations