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Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia

Primary Purpose

Alzheimer's Dementia, Falls, Gait Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wii-Fit intervention
Walking exercise program
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Dementia focused on measuring Alzheimer's dementia, Wii-Fit, Walking, Falls

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects age ≥ 60
  • Diagnosis of mild Dementia of Alzheimer's type (MMSE ≥ 18)
  • Community dwelling elders, living at home
  • History of fall at least once during the year before the study (without serious injury) or a fear of a future fall
  • Presence of caregiver(s)
  • Presence of television at home

Exclusion Criteria:

  • History of myocardial infarction or TIA or stroke in last 6 months
  • Presence of serious psychiatric problems that have impact on memory
  • Active cancer or new cancer diagnosis in the last year other than skin cancer
  • Medical conditions likely to compromise survival, or ability to participate in the exercise program such as severe congestive heart failure, significant musculoskeletal impairments, recent fracture, joint replacements, or severe chronic pain
  • Severe visual or auditory impairment or peripheral neuropathy
  • Subjects using wheel chair or assistive device for mobility

Sites / Locations

  • University of Nebrasaka Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wii-Fit arm

Walking arm

Arm Description

Half hour daily, five days a week, for 8 weeks

Half hour daily, five days a week, for 8 weeks

Outcomes

Primary Outcome Measures

Berg Balance Test
Biomechanical assessment of balance, gait and dual tasking

Secondary Outcome Measures

Activities of daily living (ADL)
Instrumental activities of daily living (IADL)
Quality Of Life-AD (QOL-AD)
Mini mental state exam (MMSE)
Falls Efficacy Scale (FES)
Activities-specific Balance Confidence Scale (ABC)
Exit-25

Full Information

First Posted
October 23, 2009
Last Updated
September 1, 2017
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01002586
Brief Title
Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
Official Title
Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Alzheimer's Dementia (AD) contributes to poor balance, impaired gait and functional status, thereby, increasing the risk of falls. AD is an independent risk factor for hip fractures. Those with balance problems and gait impairments are at higher risk for long term placement and death related to falls. Gait impairments in those with dementia include shortened step length, increased double support time, step to step variability, and decreased gait speed. These gait impairments worsen with dual tasking probably due to common brain areas involved in gait and other cognitive tasks. Exercise interventions improve gait and balance in the elderly. In subjects with existing AD, physical activity has shown to prevent further cognitive decline and improve quality of life and prevent falls. However, it is difficult to engage patients with AD in long term exercise programs. The expense of physical therapy limits its easy accessibility. Use of everyday technology might bridge this gap by providing high level of engagement via the use of multimedia while providing a cost effective alternative. Wii Fit is one such multimedia platform. Wii fit is a Nintendo gaming console used for aerobics, strength training and balance activities. This device includes a balance board that senses weight and shifts in movement and balance. Virtual trainers talk the user through the activity while tracking the user's progress. Although some skilled nursing facilities have started using Wii game system adjunct to routine physical therapy, there have not been any studies. Anecdotal reports note improvement in balance and social benefits using the Wii Fit program. Physical therapists report the ability to customize Wii for each patient. Wii Fit can be successfully used in a cognitively impaired population. A unique feature of this approach is the enjoyment and enthusiasm that many patients derive which is reflected in high levels of engagement. The invesitgators propose an 8 week prospective randomized study with the treatment group receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a walking exercise program in a community dwelling setting. Subjects in each arm will participate for 30 minutes daily five days a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Dementia, Falls, Gait Impairment, Balance Impairment
Keywords
Alzheimer's dementia, Wii-Fit, Walking, Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wii-Fit arm
Arm Type
Experimental
Arm Description
Half hour daily, five days a week, for 8 weeks
Arm Title
Walking arm
Arm Type
Active Comparator
Arm Description
Half hour daily, five days a week, for 8 weeks
Intervention Type
Other
Intervention Name(s)
Wii-Fit intervention
Other Intervention Name(s)
Exercise intervention
Intervention Description
Half hour daily, five days a week, for 8 weeks
Intervention Type
Other
Intervention Name(s)
Walking exercise program
Intervention Description
walking exercise program
Primary Outcome Measure Information:
Title
Berg Balance Test
Time Frame
8 weeks and 16 weeks
Title
Biomechanical assessment of balance, gait and dual tasking
Time Frame
8 weeks and 16 weeks
Secondary Outcome Measure Information:
Title
Activities of daily living (ADL)
Time Frame
8 weeks and 16 weeks
Title
Instrumental activities of daily living (IADL)
Time Frame
8 weeks and 16 weeks
Title
Quality Of Life-AD (QOL-AD)
Time Frame
8 weeks and 16 weeks
Title
Mini mental state exam (MMSE)
Time Frame
8 weeks and 16 weeks
Title
Falls Efficacy Scale (FES)
Time Frame
8 weeks and 16 weeks
Title
Activities-specific Balance Confidence Scale (ABC)
Time Frame
8 weeks and 16 weeks
Title
Exit-25
Time Frame
8 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects age ≥ 60 Diagnosis of mild Dementia of Alzheimer's type (MMSE ≥ 18) Community dwelling elders, living at home History of fall at least once during the year before the study (without serious injury) or a fear of a future fall Presence of caregiver(s) Presence of television at home Exclusion Criteria: History of myocardial infarction or TIA or stroke in last 6 months Presence of serious psychiatric problems that have impact on memory Active cancer or new cancer diagnosis in the last year other than skin cancer Medical conditions likely to compromise survival, or ability to participate in the exercise program such as severe congestive heart failure, significant musculoskeletal impairments, recent fracture, joint replacements, or severe chronic pain Severe visual or auditory impairment or peripheral neuropathy Subjects using wheel chair or assistive device for mobility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpana P Padala, MD, MS
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebrasaka Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

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Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia

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