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

Primary Purpose

Huntington Disease, Lewy Body Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill Walking
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Treadmill, Walking, Gait, Exercise

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University Physical Therapy Division

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treadmill Walking

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Spatiotemporal gait measures
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.
Timed Up and Go Test
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.
Q-motor testing
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.

Full Information

First Posted
October 10, 2014
Last Updated
September 26, 2016
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT02268617
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease, Lewy Body Disease
Keywords
Treadmill, Walking, Gait, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill Walking
Arm Type
Experimental
Arm Description
All subjects will walk on treadmill for a total of 20 minutes.
Intervention Type
Other
Intervention Name(s)
Treadmill Walking
Intervention 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 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.
Primary Outcome Measure Information:
Title
Vital signs
Description
Blood pressure, heart rate, and rating of perceived exertion will be measured before, during, and after treadmill walking.
Time Frame
Within 24 hours
Secondary Outcome Measure Information:
Title
Spatiotemporal gait measures
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.
Time Frame
within 24 hours
Title
Timed Up and Go Test
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.
Time Frame
Within 24 hours
Title
Q-motor testing
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.
Time Frame
Within 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Kloos, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Physical Therapy Division
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18464281
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.
Results Reference
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PubMed Identifier
21068430
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.
Results Reference
background
PubMed Identifier
15390128
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. doi: 10.1002/mds.20294.
Results Reference
background
PubMed Identifier
11347241
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. No abstract available.
Results Reference
background
PubMed Identifier
15929090
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. doi: 10.1002/mds.20507.
Results Reference
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Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease

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