Solid TumorsNCT00601133
Function and Balance for Inpatient Rehabilitation
An observational study of Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Walking Test, Balance Test and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have completed acute inpatient rehabilitation at MDACC
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Solid Tumors
- Being tested
- Walking Test, Balance Test, Questionnaire, Diary
- Keywords
- Solid Tumors, Acute Inpatient Rehabilitation, Postural Instability, Balance, Function, Walking, Questionnaire, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking TestOther
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
Balance TestOther
Machine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed.
QuestionnaireBehavioural
Also called Survey
To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes.
DiaryBehavioural
Also called journal
Record any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Walking Test; Other: Balance Test; Behavioral: Questionnaire; Behavioral: Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Results of functional tests of postural control (Timed 50 feet walk + Timed Get Up & Go Test)
Measured: Observation points at baseline (discharge) and at post discharge week 4 +/- 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Guo, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601133
- Sponsor's protocol ID
- 2007-0799
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Clinical Description of Postural Instability in Patient Who Underwent Acute Inpatient Rehabilitation and at Follow-Up
- ClinicalTrials.gov ID
- NCT00601133
- Acronym / sponsor ID
- 2007-0799
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Acute Inpatient Rehabilitation, Postural Instability, Balance, Function, Walking, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Postural Instability | – | Other: Walking Test, Other: Balance Test, Behavioral: Questionnaire, Behavioral: DiaryParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have completed acute inpatient rehabilitation at MDACC
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking TestTimed 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 | Patient Postural Instability |
| Balance TestMachine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed. | Other | Patient Postural Instability |
| QuestionnaireAlso: SurveyTo be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes. | Behavioural | Patient Postural Instability |
| DiaryAlso: journalRecord any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry | Behavioural | Patient Postural Instability |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
Related trials for Solid Tumors
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
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RecruitingPhase 1/2
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RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
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SW-682 in Advanced Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Guo, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.