NCT02268617

Brief Summary

Individuals with Dementia with Lewy Bodies (DLB) and Huntington's disease (HD) experience balance and walking problems that lead to falls. Treadmill walking has demonstrated improvements in balance and walking and fall risk in individuals with Parkinson's disease (PD), suggesting that it may be beneficial for individuals with DLB and HD. In PD subjects, changes in gait parameters have been noted after only one treadmill training session. The investigators propose a pilot study to investigate the safety, feasibility, and utility to improve mobility and fall risk of a single session of treadmill walking in individuals with DLB and HD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 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

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

3.5 years

First QC Date

October 10, 2014

Last Update Submit

September 26, 2016

Conditions

Keywords

TreadmillWalkingGaitExercise

Outcome Measures

Primary Outcomes (1)

  • Vital signs

    Blood pressure, heart rate, and rating of perceived exertion will be measured before, during, and after treadmill walking.

    Within 24 hours

Secondary Outcomes (3)

  • Spatiotemporal gait measures

    within 24 hours

  • Timed Up and Go Test

    Within 24 hours

  • Q-motor testing

    Within 24 hours

Study Arms (1)

Treadmill Walking

EXPERIMENTAL

All subjects will walk on treadmill for a total of 20 minutes.

Other: Treadmill Walking

Interventions

Following instructions and familiarization with the treadmill, participants will walk on the treadmill for 20 minutes total with rest periods as needed. Treadmill speed will be set at each participant's overground comfortable walking speed for the first 5 minutes, provided that they can walk safely. If necessary the speed will be lowered until a safe gait is achieved. After 5 minutes the speed will be incrementally increased by10% each 5 minutes (3 times) as long as a safe gait (i.e., no abnormal vital signs, excessive effort, or loss of balance occurrences) can be maintained. If the gait pattern becomes unsafe or more abnormal the speed will revert to the previous safe speed and be maintained at this level until the end of training session.

Treadmill Walking

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Huntington's disease or Dementia with Lewy Bodies,
  • the ability to ambulate 80 feet without assistance, and
  • the ability to provide informed consent and understand directions.

You may not qualify if:

  • presence of any clinically significant musculoskeletal or neurological disease that would affect gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Physical Therapy Division

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

  • Bello O, Sanchez JA, Fernandez-del-Olmo M. Treadmill walking in Parkinson's disease patients: adaptation and generalization effect. Mov Disord. 2008 Jul 15;23(9):1243-9. doi: 10.1002/mds.22069.

    PMID: 18464281BACKGROUND
  • Bechtel N, Scahill RI, Rosas HD, Acharya T, van den Bogaard SJ, Jauffret C, Say MJ, Sturrock A, Johnson H, Onorato CE, Salat DH, Durr A, Leavitt BR, Roos RA, Landwehrmeyer GB, Langbehn DR, Stout JC, Tabrizi SJ, Reilmann R. Tapping linked to function and structure in premanifest and symptomatic Huntington disease. Neurology. 2010 Dec 14;75(24):2150-60. doi: 10.1212/WNL.0b013e3182020123. Epub 2010 Nov 10.

    PMID: 21068430BACKGROUND
  • Bilney B, Morris ME, Churchyard A, Chiu E, Georgiou-Karistianis N. Evidence for a disorder of locomotor timing in Huntington's disease. Mov Disord. 2005 Jan;20(1):51-7. doi: 10.1002/mds.20294.

    PMID: 15390128BACKGROUND
  • Churchyard AJ, Morris ME, Georgiou N, Chiu E, Cooper R, Iansek R. Gait dysfunction in Huntington's disease: parkinsonism and a disorder of timing. Implications for movement rehabilitation. Adv Neurol. 2001;87:375-85. No abstract available.

    PMID: 11347241BACKGROUND
  • Frenkel-Toledo S, Giladi N, Peretz C, Herman T, Gruendlinger L, Hausdorff JM. Treadmill walking as an external pacemaker to improve gait rhythm and stability in Parkinson's disease. Mov Disord. 2005 Sep;20(9):1109-14. doi: 10.1002/mds.20507.

    PMID: 15929090BACKGROUND

MeSH Terms

Conditions

Huntington DiseaseLewy Body DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental DisordersParkinsonian DisordersSynucleinopathiesBehavior

Study Officials

  • Anne Kloos, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

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 Clinical Professor

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 20, 2014

Study Start

February 1, 2013

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations