Function and Balance for Inpatient Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00601133
First received: January 14, 2008
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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.


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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
Other Name: Survey
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
Other Name: journal

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

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ying Guo, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00601133     History of Changes
Other Study ID Numbers: 2007-0799
Study First Received: January 14, 2008
Last Updated: January 9, 2013
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

ClinicalTrials.gov processed this record on August 26, 2014