Difficulty WalkingTUGNCT01807273
Time Up and go in Hemiplegic Patients
An observational study of Difficulty Walking, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficulty Walking
- What is being tested?
- Walking test
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 hemiplegic out patients
Who may be able to join
- Patients performing 3D gait analysis
- Male or female adults aged ≥ 18 years,
- Hemiplegia following unique stroke- Patients with hemiplegia able to stand up alone,walk and turn around alone without assistance.
Who cannot join
- Patient with a protective measure,
- Pregnant women, breastfeeding
- Brain damage bilateral cerebellar syndrome, apraxia and / or severe aphasia,
- Patient who received botulinum toxin injection in the 3 months prior to inclusion, patients who underwent surgery of the locomotor system in the 6 months prior to inclusion,
- No affiliation to a social security
- other pathology, complications with significant impact on the activities of walking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Biomechanical Parameters of Functional Task Time Up and Go in Hemiplegic Patients
Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis
Read the detailed description
The timed up and go is a routine quick test assessing motor functional tasks including stand up ,walk 3 m,turn around and sitting down.We will included hemiplegic patients to quantify biomechanic parameters
- Conditions
- Difficulty Walking
- Being tested
- Walking test
- Keywords
- hemiplegic, time up and go test, motion analysis, center of mass
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking testOther
Also called The TUG test included stand up ,walk,turn around ,sit down
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegic subjects | 60 hemiplegic outpatients walking test Receives: Other: Walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of the center of mass
subjects will perform the TUG test with 3D walk analysis equipment
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficulty WalkingStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Nicolas ROCHE, MDPHD, Principal investigator, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807273
- Sponsor's protocol ID
- 2012-A01619-3
- Acronym
- TUG
- Status last verified
- Jan 2014
- First submitted
- 7 Mar 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Biomechanical Parameters of Functional Task Time Up and Go in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT01807273
- Acronym / sponsor ID
- TUG / 2012-A01619-3
- Conditions
- Difficulty Walking
- Keywords
- hemiplegic, time up and go test, motion analysis, center of mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Mar 2013 (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.
Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis
Detailed description
The timed up and go is a routine quick test assessing motor functional tasks including stand up ,walk 3 m,turn around and sitting down.We will included hemiplegic patients to quantify biomechanic parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegic subjects | – | Other: Walking test60 hemiplegic outpatients walking test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 hemiplegic out patients
Key inclusion criteria (3 listed)
- Patients performing 3D gait analysis
- Male or female adults aged ≥ 18 years,
- Hemiplegia following unique stroke- Patients with hemiplegia able to stand up alone,walk and turn around alone without assistance.
Key exclusion criteria (6 listed)
- Patient with a protective measure,
- Pregnant women, breastfeeding
- Brain damage bilateral cerebellar syndrome, apraxia and / or severe aphasia,
- Patient who received botulinum toxin injection in the 3 months prior to inclusion, patients who underwent surgery of the locomotor system in the 6 months prior to inclusion,
- No affiliation to a social security
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 testAlso: The TUG test included stand up ,walk,turn around ,sit down | Other | Hemiplegic subjects |
Primary outcome
Variability of the center of mass
Time frame: 1 hour
subjects will perform the TUG test with 3D walk analysis equipment
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 4 Feb 2015.
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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.
Nicolas ROCHE, MDPHD principal investigator
HOPITAL RAYMOND POINCARE
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 Difficulty Walking, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 6 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 4 Feb 2015. 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 France. 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?
Variability of the center of mass (time frame: 1 hour). 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 4 Feb 2015.