Clinical trial NCT00601133: Function and Balance for Inpatient Rehabilitation
Official title: Quantitative and Clinical Description of Postural Instability in Patient Who Underwent Acute Inpatient Rehabilitation and at Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumors
Keywords: Solid Tumors
Acute Inpatient Rehabilitation
Postural Instability
Balance
Function
Walking
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have completed acute inpatient rehabilitation at MDACC

Brief summary: Objectives:

Primary Objectives:

To determine the change in functional tests of postural control of cancer patients who have completed acute inpatient rehabilitation or complete rehabilitation through mobile team from discharge at 21-60 days (+/- 3) after discharge.

Secondary Objectives:

To assess the correlations between the functional tests of postural control, the balance test and the amount of exercise per week.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Results of functional tests of postural control (Timed 50 feet walk + Timed Get Up & Go Test)
timeFrame: Observation points at baseline (discharge) and at post discharge week 4 +/- 1
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ying Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: