NCT00601133

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

5 years

First QC Date

January 14, 2008

Last Update Submit

January 9, 2013

Conditions

Keywords

Solid TumorsAcute Inpatient RehabilitationPostural InstabilityBalanceFunctionWalkingQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 TestOther: Balance TestBehavioral: QuestionnaireBehavioral: Diary

Interventions

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

Patient Postural Instability

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

Patient Postural Instability
QuestionnaireBEHAVIORAL

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
Patient Postural Instability
DiaryBEHAVIORAL

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
Patient Postural Instability

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have completed acute inpatient rehabilitation at MDACC

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ying Guo, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations