Function and Balance for Inpatient Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Other: Walking Test; Other: Balance Test; Behavioral: Questionnaire; Behavioral: Diary

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have completed acute inpatient rehabilitation at MDACC

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 Names: 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 Names: journal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Results of functional tests of postural control (Timed 50 feet walk + Timed Get Up & Go Test)	Observation points at baseline (discharge) and at post discharge week 4 +/- 1

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Ying Guo, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• The University of Texas M.D.Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): January 25, 2008

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 9, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Balance; Questionnaire; Survey; Walking; Function; Solid Tumors; Acute Inpatient Rehabilitation; Postural Instability
• Other Study ID Numbers: 2007-0799