Function and Balance for Inpatient Rehabilitation - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00601133

Purpose

Primary Objective:

1. To determine the change in functional tests of postural control of cancer patients who have completed acute inpatient rehabilitation from discharge at one month (+/-1wk) after discharge.

Secondary Objective:

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

Condition	Intervention
Solid Tumors	Other: Walking Test Other: Balance Test Behavioral: Questionnaire Behavioral: Diary

MedlinePlus related topics: Cancer Exercise and Physical Fitness Rehabilitation

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Quantitative and Clinical Description of Postural Instability in Patient Who Underwent Acute Inpatient Rehabilitation and at Follow-Up

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To find out how well you can walk and keep your balance 4 weeks after leaving the inpatient rehabilitation program at M. D. Anderson. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	58
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Participants having difficulty walking and with balance after cancer treatment that are leaving the M.D. Anderson rehabilitation hospital.	Other: 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 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. Behavioral: Questionnaire To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes. 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

Groups/Cohorts

Assigned Interventions

1

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

Other: 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

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.

Behavioral: Questionnaire

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

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

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, and again at a return visit 1 month 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 1 month 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 1 month 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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who have completed acute inpatient rehabilitation at MDACC

Criteria

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 underwent acute inpatient rehabilitation at MDACC.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601133

Contacts

Contact: Ying Guo, MD

713-745-2327

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Ying Guo, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Ying Guo, MD

U.T.M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Ying Guo, MD/Associate Professor )
Study ID Numbers:	2007-0799
Study First Received:	January 14, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00601133
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Solid Tumors
Acute Inpatient Rehabilitation
Postural Instability
Balance

Function
Walking
Questionnaire
Survey

Study placed in the following topic categories:

Benzocaine

ClinicalTrials.gov processed this record on January 16, 2009