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Parkinson's DiseasePhase 2NCT01162226

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

A Phase 2 study testing gait and balance training program in people with Parkinson's Disease, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson's Disease
What is being tested?
gait and balance training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
Sep 2010to Jul 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
  • Hoehn \& Yahr disease Stage 1 (unilateral disease) to 3 (mild to moderate bilateral disease, physically independent) (Fahn and Elton, 1987).

Who cannot join

  • 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).
  • 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)
  • visual or hearing impairments serious enough to interfere with their ability to interact with the computer-based training program.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143-0610

Other trials in United States

About this study

Official title: "PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".

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.

Being tested
gait and balance training program
Keywords
gait, movement disorders, balance, function
Medical subject headings
Parkinson Disease, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gait and balance training programBehavioural

    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.

Study groups in NCT01162226
Study groupRoleWhat they receive
training programExperimentalNot described
Receives: Behavioral: gait and balance training program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. gait

    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.

    Measured: 3 months

  2. balance

    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.

    Measured: 3 months

Secondary outcomes (4)

  1. falls

    Weekly phone inquiry will quantify number of falls if any, during the past week.

    Measured: weeks 1-12

  2. overall functional status

    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.

    Measured: 3 months

  3. subjective balance

    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.

    Measured: 3 months

  4. balance

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01162226
Sponsor's protocol ID
2R42NS061502-02
Other IDs
2R42NS061502-02
Status last verified
Apr 2012
First submitted
24 Jun 2010
Last updated
19 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • Fahn, S., Elton, R., & Members, U. C. (1987). Unified Parkinson's disease rating scale. In S. Fahn, C. D. Mardsen, M. Goldstein & D. Calne (Eds.), Recent Developments in Parkinson's Disease (pp. 153-163). New Jersey: Macmillan Healthcare Information. Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975).

  • Folstein MF, Folstein SE, McHugh PR.

  • Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.

    PubMed 9923759

  • Hughes AJ, Ben-Shlomo Y, Daniel SE, Lees AJ. What features improve the accuracy of clinical diagnosis in Parkinson's disease: a clinicopathologic study. Neurology. 1992 Jun;42(6):1142-6. doi: 10.1212/wnl.42.6.1142.

    PubMed 1603339

  • Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

    PubMed 7814786

  • Shumway-Cook A, Horak FB. Assessing the influence of sensory interaction of balance. Suggestion from the field. Phys Ther. 1986 Oct;66(10):1548-50. doi: 10.1093/ptj/66.10.1548. No abstract available.

    PubMed 3763708

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gait and balance training program in people with Parkinson's Disease, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gait (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01162226, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.

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