Function and Balance for Inpatient Rehabilitation

NCT ID: NCT00601133

Last Updated: 2013-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Solid Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Postural Instability

Participants having difficulty walking and with balance after cancer treatment that are leaving the M.D. Anderson rehabilitation hospital or after treatment through the rehabilitation mobile team.

Walking Test

Intervention Type OTHER

Timed Test 1: From sitting position walk 10 feet quickly, return to sitting position Timed Test 2: Walk 25 feet, turn around, and walk back

Tests conducted twice, once on departure from rehabilitation center, and again at a return visit 1 month later

Balance Test

Intervention Type OTHER

Machine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed.

Questionnaire

Intervention Type BEHAVIORAL

To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes.

Diary

Intervention Type BEHAVIORAL

Record any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry

Interventions

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Walking Test

Timed Test 1: From sitting position walk 10 feet quickly, return to sitting position Timed Test 2: Walk 25 feet, turn around, and walk back

Tests conducted twice, once on departure from rehabilitation center, and again at a return visit 1 month later

Intervention Type OTHER

Balance Test

Machine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed.

Intervention Type OTHER

Questionnaire

To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes.

Intervention Type BEHAVIORAL

Diary

Record any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey journal

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Guo, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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UT MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

The University of Texas M.D.Anderson Cancer Center

Other Identifiers

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2007-0799

Identifier Type: -

Identifier Source: org_study_id

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