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Wii-fit for Activity, Balance and Gait in Assisted Living

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01000038
Recruitment Status : Unknown
Verified October 2009 by University of Nebraska.
Recruitment status was:  Recruiting
First Posted : October 22, 2009
Last Update Posted : October 27, 2009
Information provided by:

Study Description
Brief Summary:

Purpose of the study: Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors for falls. Improving balance and gait abnormalities is critical to prevent falls in AD.

Exercise interventions improve gait and balance in elderly. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers to exercise programs include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT). Use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price.

Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. This device includes a balance board that senses weight, movement and balance. Wii-Fit is a TV based self-directed activity not limited by the constraint of a therapist's presence. Virtual trainers talk the user through the activity while tracking progress. Furthermore, visual and auditory feedback improves engagement. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT, and note improvement in balance along with social benefits but no systematic studies are done to generalize the findings.

The investigators 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.

Condition or disease Intervention/treatment
Falls Alzheimer's Disease Other: Wii-Fit intervention Other: Walking

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Wii-fit for Activity, Balance and Gait in Assisted Living
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Wii-Fit arm Other: Wii-Fit intervention
Half hour daily, 5 days a week for 8 weeks
Other Name: Exercise intervention
Other: Walking
Half hour daily, five days a week for 8 weeks
Other Name: Exercise intervention
Active Comparator: Walking arm Other: Walking
Half hour daily, five days a week for 8 weeks
Other Name: Exercise intervention

Outcome Measures

Primary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Activities of Daily Living [ Time Frame: 8 weeks ]
  2. Instrumental Activities of Daily Living [ Time Frame: 8 weeks ]
  3. Timed Up and Go [ Time Frame: 8 weeks ]
  4. Quality of Life-AD [ Time Frame: 8 weeks ]
  5. Mini Mental State Exam [ Time Frame: 8 weeks ]
  6. Actigraphy [ Time Frame: 3 days before the intervention and 3 days during the intervention ]
  7. Trails A and B [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 60
  • Alzheimer's Dementia, mild (MMSE ≥ 18)
  • Residing in assisted living facility
  • Presence of legal surrogate

Exclusion Criteria:

  • History of myocardial infarction, TIA or stroke in last 6 months
  • Presence of serious mental illness impacting memory
  • Active cancer except skin cancer
  • Medical conditions likely to compromise survival (e.g. severe congestive heart failure)
  • Severe sensory and musculoskeletal impairments
  • Using wheel-chair
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000038

Contact: Kalpana P Padala, MD,MS 402-559-8069 kpadala@unmc.edu

United States, Nebraska
Parson's House Assisted Living Recruiting
Omaha, Nebraska, United States, 68164
Principal Investigator: Kalpana P Padala, MD, MS         
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Kalpana P Padala, MD, MS University of Nebraska
More Information

Responsible Party: Kalpana P. Padala, MD, MS, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01000038     History of Changes
Other Study ID Numbers: 085-09-FB
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by University of Nebraska:
Assisted living
Alzheimer's dementia

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders