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Completed

NCT Number: NCT00601133

Function and Balance for Inpatient Rehabilitation

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.

Completed

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Key information

Conditions

Solid Tumors

Sex eligibility

All sexes

Study type

Observational

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients, or the legal guardians of patients, must have the ability to understand and willingness to sign a written informed consent document.
  • Patients must be able to ambulate with or without assistant device, without assistance from a person.
  • Patients must have undergone acute inpatient rehabilitation at MDACC or undergone rehabilitation through mobile team.

Exclusion criteria

  • Patients who decline to participate or who are determined incapable of completing the research.
  • Active CNS disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
  • Patient who is not willing or able to come back for 4+/-1 week routine follow-up.

Treatment and study plan

walking test

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

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

Behavioral

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

Other names: Survey

Diary

Behavioral

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

Other names: journal

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2008
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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