Expired Study
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Columbus, Ohio 43210


Purpose:

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.


Study summary:

Several studies using HD animal models have shown that HD mice housed in enriched environments or in cages with running wheels that stimulated physical activity demonstrated a delayed onset and/or slowed decline in motor function compared to mice in non-enriched environments (van Dellen et al. 2000, 2008; Spires et al., 2004). Evidence suggests that aerobic exercise may have neuroprotective effects and helps the elderly and individuals with neurodegenerative diseases to maintain better cognitive and motor function than those who are inactive. More specifically, there is strong evidence from animal and human trials in neurological populations (i.e., Parkinson's Disease, spinal cord injury, and stroke) that treadmill training can improve walking and motor function. Immediate effects of a single-session of treadmill walking in the Parkinson's Disease population were improved over-ground gait measures (i.e., gait speed, stride length, double support percent, stride variability) and longer term treadmill training studies demonstrated additional improvements in Unified Parkinson Disease Rating Scale scores, fall risk, and health-related quality of life (Herman et al., 2008). This study builds upon foundational knowledge gained in animals and other neurologic populations to determine the feasibility, safety and possible immediate benefit of treadmill walking in individuals with HD. The primary purpose of this pilot study is to investigate the the safety, feasibility and utility of a single 20-minute session of treadmill walking to improve gait parameters in ambulatory individuals with DLB and HD. Secondarily we will explore the effects of treadmill walking on mobility, fall risk, and motor coordination. Based on previous studies utilizing a single-session of treadmill training in the PD population, we hypothesize that treadmill walking will improve overground spatiotemporal gait parameters (gait speed, stride length, double support percent, and stride-to-stride variations in gait) in individuals with DLB and HD (Pohl et al., 2003; Frenkel-Toledo et al., 2005; Bello et al., 2008).


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - presence of any clinically significant musculoskeletal or neurological disease that would affect gait.


Study is Available At:


Original ID:

2012H0385


NCT ID:

NCT02268617


Secondary ID:


Study Acronym:


Brief Title:

Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease


Official Title:

Immediate Effects of Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anne Kloos, PhD
Principal Investigator
Ohio State University

Study Dates

Start Date:February 2013
Completion Date:September 2016
Completion Type:Actual
Primary Completion Date:August 2016
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:September 26, 2016
First Received Date:October 10, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Q-motor testing
Time Frame:Within 24 hours
Safety Issues:False
Description:Motor coordination will be measured using force-transducer based measurement of grip forces during grasping and holding an object and of tapping forces and tap interval variability during fast repetitive finger and foot tapping.
Outcome Type:Secondary Outcome
Measure:Timed Up and Go Test
Time Frame:Within 24 hours
Safety Issues:False
Description:Mobility and fall risk will be measured using the Timed Up and Go Test (TUG) that includes standing up from a chair, walking 3 meters, turning and returning to sitting in the chair.
Outcome Type:Secondary Outcome
Measure:Spatiotemporal gait measures
Time Frame:within 24 hours
Safety Issues:False
Description:Spatiotemporal gait parameters will be measured using a computerized system, a 4.88 meter electronic carpet equipped with sensors that record footfalls and communicate the information to a computer software program.
Outcome Type:Primary Outcome
Measure:Vital signs
Time Frame:Within 24 hours
Safety Issues:True
Description:Blood pressure, heart rate, and rating of perceived exertion will be measured before, during, and after treadmill walking.

Study Interventions

Intervention Type:Other
Name:Treadmill Walking
Description: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 abnorma
Arm Name:Treadmill Walking

Study Arms

Study Arm Type:Experimental
Arm Name:Treadmill Walking
Description:All subjects will walk on treadmill for a total of 20 minutes.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:15929090
Reference Type:Reference
Citation: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.
PMID:11347241
Reference Type:Reference
Citation: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.
PMID:15390128
Reference Type:Reference
Citation: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:21068430
Reference Type:Reference
Citation: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:18464281

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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