Computer-Based Balance Training for People With Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Glenna Dowling, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01162226
First received: June 24, 2010
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

This study will be carried out to determine the effectiveness of in-home computer games played by a person with Parkinson's disease for 50 minutes 3 times a week on measures of standing and walking balance.


Condition Intervention Phase
Parkinson's Disease
Behavioral: gait and balance training program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • gait [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Gait velocity and stride length will be measured with WriteStep Gait and Mobility pads (Abilitations). For the gait analysis, subjects will walk along a 10 foot walkway (gait velocity) that will record the footprint patterns from which we will evaluate the time it takes to walk the distance of the walkway and the average stride length. Each subject will walk according to standard protocol of 1 trial at his/her self-selected speed to enable an accurate representation of usual gait.

  • balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Balance will be objectively measured using the modified Clinical Test for Sensory Interaction and Balance (CTSIB) (Shumway-Cook & Horak, 1986). There are 2 conditions with a stable platform (eyes open and eyes closed) and 2 conditions on a less stable foam surface, (eyes open and eyes closed). Following the standardized protocol, subjects will be tested 3 times in each condition on the stable surface and 3 times in each unstable condition for up to thirty seconds each. The number of seconds standing will be summed across all 12 trials for a range of 0-360 seconds.


Secondary Outcome Measures:
  • falls [ Time Frame: weeks 1-12 ] [ Designated as safety issue: Yes ]
    Weekly phone inquiry will quantify number of falls if any, during the past week.

  • overall functional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Functional status will be assessed by the Unified Parkinson's Disease Rating Scale (UPDRS, Parts 2 & 3) (Fahn, Elton, & Members of the UPDRS Committee, 1987). Part 2 is a quantitative 5-point scale that measures the subjects' perception of their functional status. Part 3 is also a 5-point scale in which a clinician evaluates actual functional status by physical exam. The scores on each item in Parts 2 & 3 are summed to yield a total score.

  • subjective balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Subjective balance will be assessed by the Activities-specific Balance Confidence (ABC) Scale (Powell & Myers, 1995). This instrument assesses subjective balance/fear of falling by asking subjects to rate the degree of confidence that they have for completing 16 activities of daily living without falling. Ratings are summed and then divided by 16 (or the number of items completed) to yield a total ABC score.

  • balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Timed up and go test (TUG) will be a secondary measure of balance. Subjects are seated in a straight back chair with arms. On the command "GO" the stop watch is started. Subject stands, walks toward a visible object on the floor positioned 8 feet from chair, walk around the object, return to chair and sit down. After a practice, 3 TUG will be performed. Times will be documented in seconds.


Enrollment: 62
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: training program Behavioral: gait and balance training program
The intervention will be implemented via three 50-minute training sessions per week for 12 weeks. The games will be played when the subject is receiving the maximum benefit from their anti-parkinsonian medications. The control group and the intervention group will receive weekly telephone calls to inquire about medications and falls. At baseline and end of the 12 weeks, in-home testing will determine stride length and speed; standing balance eyes open and closed on flat and foam surface.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. presence of bradykinesia along with at least one of the following: muscular rigidity, 4-6 Hz rest tremor, and postural instability (Gelb, Oliver, & Gilman, 1999; Hughes, Ben-Shlomo, Daniel, & Lees, 1992).
  2. Hoehn & Yahr disease Stage 1 (unilateral disease) to 3 (mild to moderate bilateral disease, physically independent) (Fahn and Elton, 1987).

Exclusion Criteria:

  1. history of strokes, repeated head injury, encephalitis, oculogyric crises, neuroleptic treatment, MPTP exposure, more than one affected relative, sustained remission, strictly unilateral features after 3 years, supranuclear gaze palsy, early severe autonomic involvement or dementia, Babinski sign, tumor, or a negative response to L-DOPA (Hughes et al., 1992).
  2. other neurologic, orthopedic or cardiac problems, cognitive impairment as evidenced by 5 or more errors on the Mini Mental State Examination (MMSE) (Folstein, Folstein, & McHugh, 1975)
  3. visual or hearing impairments serious enough to interfere with their ability to interact with the computer-based training program.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162226

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0610
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Glenna A Dowling, PhD University of Ca San Francisco
  More Information

Publications:
Responsible Party: Glenna Dowling, RN, PhD, FAAN, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01162226     History of Changes
Other Study ID Numbers: 2R42NS061502-02, 2R42NS061502-02
Study First Received: June 24, 2010
Last Updated: April 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
gait
movement disorders
balance
function

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 16, 2014