ClinicalTrials.gg
CompletedNCT00601133Updated Jan 10, 2013

Function and Balance for Inpatient Rehabilitation

An observational study in Solid Tumors, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
24
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Solid Tumors

Keywords

  • Solid Tumors
  • Acute Inpatient Rehabilitation
  • Postural Instability
  • Balance
  • Function
  • Walking
  • Questionnaire
  • Survey
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.

Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have completed acute inpatient rehabilitation at MDACC

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • 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.

    Other: Walking Test · Other: Balance Test · Behavioral: Questionnaire · Behavioral: Diary

Interventions

  • OtherWalking 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

  • OtherBalance Test

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

  • BehavioralQuestionnaire

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

    Also known as: Survey

  • BehavioralDiary

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

    Also known as: journal

06

What researchers measure

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

07

Study locations

1 site
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Jan 2013 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2008
First posted
Jan 25, 2008
Start
Jan 2008
Primary completionActual
Jan 2013
CompletionActual
Jan 2013
Last update
Jan 10, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00601133
Responsible party
Sponsor
First posted
Jan 25, 2008
Start date
Jan 2008
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Jan 10, 2013

Study contacts

Ying Guo, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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