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Quantitative and Clinical Description of Postural Instability in Patient Who Underwent Acute Inpatient Rehabilitation and at Follow-Up


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Solid Tumors

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Trial Information

Quantitative and Clinical Description of Postural Instability in Patient Who Underwent Acute Inpatient Rehabilitation and at Follow-Up


To be enrolled in this study, you must be able to walk with or without an assistant device
(such as a cane or a walker).

Study Procedures:

If you are found to be eligible to take part in this study, you will do a combination of
walking and balance tests twice, once on the day you leave the rehabilitation center or
hospital, and again at a return visit 21-60 days (+/-3) later. For the first test, you will
get up from a chair and walk 10 feet as quickly, but as safely, as possible. You will then
return to the chair and sit again. For the second test, you will walk 25 feet, turn around,
and walk back to the starting point as fast and as safely as you can. Both tests will be
timed by the study staff.

You will also do a balance test on a machine. You will stand on a platform with a rail to
hold on to. You will shift your weight and try to keep your balance and center of gravity,
which will be shown on a screen.

You will be given a diary to record any physical exercise you are doing from the time you
leave the rehabilitation center to your return visit 21-60 days (+/-3) later. You will be
asked to record what kind of exercises (home exercise, home health therapy, or outpatient
therapy treatment) you do and for how many hours. It should take about 5 minutes to fill out
the diary each time.

You will complete a questionnaire that asks you about your symptoms, such as pain. You will
complete it when you leave the rehabilitation program and again at the study visit 21-60
days (+/-3) later. It should take about 5 minutes to complete the questionnaire.

Length of Study:

You will be off study after you complete the second questionnaire.

This is an investigational study.

Up to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patients, or the legal guardians of patients, must have the ability to understand and
willingness to sign a written informed consent document.

2. Patients must be able to ambulate with or without assistant device, without
assistance from a person.

3. Patients must have undergone acute inpatient rehabilitation at MDACC or undergone
rehabilitation through mobile team.

Exclusion Criteria:

1. Patients who decline to participate or who are determined incapable of completing the
research.

2. Active CNS disease, such as clinically-evident metastases or leptomeningeal disease,
dementia, or encephalopathy.

3. Patient who is not willing or able to come back for 4+/-1 week routine follow-up.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Patient Results of functional tests of postural control (Timed 50 feet walk + Timed Get Up & Go Test)

Outcome Time Frame:

Observation points at baseline (discharge) and at post discharge week 4 +/- 1

Safety Issue:

No

Principal Investigator

Ying Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0799

NCT ID:

NCT00601133

Start Date:

January 2008

Completion Date:

January 2013

Related Keywords:

  • Solid Tumors
  • Solid Tumors
  • Acute Inpatient Rehabilitation
  • Postural Instability
  • Balance
  • Function
  • Walking
  • Questionnaire
  • Survey

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030