Hemiplegic PatientsEQHEMNCT02350556
Interest of Evaluating the Movement of the Center of Mass in a Dynamic Avoidance Task as the Endpoint of the Dynamic Equilibrium of Hemiplegic Patients
A study testing Dynamic Avoidance Task, physical therapy and 3D motion on optoelectronic device in people with Hemiplegic Patients, run by Rennes University Hospital at 1 site in France.
Trial summary
For several years, the postural disorders assessment in hemiplegic patients was conducted through force plate, using the center of plantar pressure displacement in a static position. These are widely used in physical therapy both for assessment and rehabilitation of patients with balance disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegic Patients
- What is being tested?
- Dynamic Avoidance Task, physical therapy and 3D motion on optoelectronic device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2015to 23 Nov 2016
- Phase
- Interventional
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- For hemiplegic patients:
- Aged between 18-80 years of age, men and women
- Left or right hemispheric sustentoriel stroke :
- oIschemic or hemorragic oFirst symptomatic episode or TIA without consequences oBetween one month and one year since the stroke
- Balance standing > 30 sec without assistance in closed eyes condition
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- FAC score included between 3 and 7
- Triceps Spasticity strictly less than 3 on the Modified Ashworth Scale with heel on the ground and an adductor spasticity up to 3 on the same scale.
- Free, informed and written consent signed by the investigator and by the patient or one of his/her relatives (in the case of a patient able to understand the information and to express his/her consent but with motor difficulties resulting in the inability to sign)
- For healthy volunteers :
- Aged between 18-85 years of age, men or women, age-matched ( +/- 5 years ) with stroke patients
- Without a balance disorder
- Affiliated to social security
- Free, informed and written consent
Who cannot join
- For hemiplegic patients:
- History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...) before the stroke
- Pregnant women
- Patient with tiredness incompatible with the tests and instrumental assessments
- Patients under legal protection (according to French law) and detainees.
- Patients physically or mentally unable of giving informed consent
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- For healthy volunteers :
- History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...)
- Receiving a psychotropic treatment (antidepressant, antipsychotic, anxiolytic)
- Pregnant women
- Within the period of exclusion in the French national register of persons suitable for biomedical research
- Patients under legal protection (according to French law) and detainees.
Trial locations and contacts
1 site in 1 country.
About this study
For several years, the postural disorders assessment in hemiplegic patients was conducted through force plate, using the center of plantar pressure displacement in a static position.
These are widely used in physical therapy both for assessment and rehabilitation of patients with balance disorders.
Read more
For hemiplegic patients, an asymmetric distribution support on each foot and an increased surface area of postural sways (more marked on the medio lateral axis) are observed.
These studies, based on the study of plantar pressure ,are not enough to providea full description of the spatio-temporal organization of postural components in hemiplegic patients.
Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton by considering it as a simple inverted pendulum swinging on his ankles.
This simplified model can't be used in dynamic assessment because of the simultaneous contributions of several joints during movement. This restricts its clinical interest because patients are more exposed to imbalances and falls in dynamic situations. Thus, the hip angular movement results in a center plantar pressure displacementwhich is impossible to discriminate from the ankle axis movement using stabilometric signal only.
Thus, it seemed interesting to study another variable valid in dynamic conditions : the displacement of center of mass during a dynamic balancing task. This variable is obtained through 3D motion capture of the different segments of the human body. The dynamic test is a dynamic postural assessment following ball avoidance from three different directions. The center of mass displacement will be compared with a functional test known to be representative of dynamic balance of the individual capacities: The Timed Up and Go test (TUG).
All of this data aims to improve the hemiplegic postural assessment for physical therapy and to help develop new rehabilitative approaches.
- Conditions
- Hemiplegic Patients
- Being tested
- Dynamic Avoidance Task, physical therapy, 3D motion on optoelectronic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Avoidance TaskOther
physical therapyProcedure or surgery
3D motion on optoelectronic deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic patients | Other | Dynamic Avoidance Task Receives: Other: Dynamic Avoidance Task; Procedure: physical therapy; Device: 3D motion on optoelectronic device |
| healthy volunteers | Other | Dynamic Avoidance Task Receives: Other: Dynamic Avoidance Task; Procedure: physical therapy; Device: 3D motion on optoelectronic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the lateral displacement of the center of mass (CoM) in the frontal plane, obtained after recording the 3D motion using an optoelectronic device
Measured: dynamic avoidance test in 7 days
Secondary outcomes (4)
- to the functional level and the balance obtained from the test: Timed Up and Go test (TUG). This comparison will be made regarding the completion time of the test and the functional score in the Get Up and Go test.
Measured: inclusion (0)
- using dynamic assessments : Maximum front displacement of the Plantar pressure center (CP) resultant when avoiding the central ball,
Measured: dynamic avoidance test in 7 days
- Using static assessments : Postural asymmetry obtained by calculating the percentage of body weight distribution on each leg during the static postural initial assessment on force plate
Measured: Inclusion (0)
The ABS TUG score (being validated) will also be compared to the lateral displacement of the center of mass (CoM).
Measured: inclusio (0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start9 Mar 2015
- Primary completion3 Jun 2016
- Study completion23 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic PatientsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350556
- Sponsor's protocol ID
- 2014-A00097-40
- Acronym
- EQHEM
- Status last verified
- May 2017
- First submitted
- 26 Jan 2015
- Last updated
- 31 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Evaluating the Movement of the Center of Mass in a Dynamic Avoidance Task as the Endpoint of the Dynamic Equilibrium of Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT02350556
- Acronym / sponsor ID
- EQHEM / 2014-A00097-40
- Conditions
- Hemiplegic Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 29 Jan 2015 (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.
For several years, the postural disorders assessment in hemiplegic patients was conducted through force plate, using the center of plantar pressure displacement in a static position.
These are widely used in physical therapy both for assessment and rehabilitation of patients with balance disorders.
For hemiplegic patients, an asymmetric distribution support on each foot and an increased surface area of postural sways (more marked on the medio lateral axis) are observed.
These studies, based on the study of plantar pressure ,are not enough to providea full description of the spatio-temporal organization of postural components in hemiplegic patients.
Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton by considering it as a simple inverted pendulum swinging on his ankles.
This simplified model can't be used in dynamic assessment because of the simultaneous contributions of several joints during movement. This restricts its clinical interest because patients are more exposed to imbalances and falls in dynamic situations. Thus, the hip angular movement results in a center plantar pressure displacementwhich is impossible to discriminate from the ankle axis movement using stabilometric signal only.
Thus, it seemed interesting to study another variable valid in dynamic conditions : the displacement of center of mass during a dynamic balancing task. This variable is obtained through 3D motion capture of the different segments of the human body. The dynamic test is a dynamic postural assessment following ball avoidance from three different directions. The center of mass displacement will be compared with a functional test known to be representative of dynamic balance of the individual capacities: The Timed Up and Go test (TUG).
All of this data aims to improve the hemiplegic postural assessment for physical therapy and to help develop new rehabilitative approaches.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemiplegic patients | Other | Other: Dynamic Avoidance Task, Procedure: physical therapy, Device: 3D motion on optoelectronic deviceDynamic Avoidance Task |
| healthy volunteers | Other | Other: Dynamic Avoidance Task, Procedure: physical therapy, Device: 3D motion on optoelectronic deviceDynamic Avoidance Task |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- -
- Aged between 18-80 years of age, men and women
- Left or right hemispheric sustentoriel stroke :
- oIschemic or hemorragic oFirst symptomatic episode or TIA without consequences oBetween one month and one year since the stroke
- Balance standing > 30 sec without assistance in closed eyes condition
Key exclusion criteria (12 listed)
- History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...) before the stroke
- Pregnant women
- Patient with tiredness incompatible with the tests and instrumental assessments
- Patients under legal protection (according to French law) and detainees.
- Patients physically or mentally unable of giving informed consent
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 |
|---|---|---|
| Dynamic Avoidance Task | Other | healthy volunteers, hemiplegic patients |
| physical therapy | Procedure or surgery | healthy volunteers, hemiplegic patients |
| 3D motion on optoelectronic device | Device | healthy volunteers, hemiplegic patients |
Primary outcome
The primary outcome is the lateral displacement of the center of mass (CoM) in the frontal plane, obtained after recording the 3D motion using an optoelectronic device
Time frame: dynamic avoidance test in 7 days
4 secondary outcomes
- to the functional level and the balance obtained from the test: Timed Up and Go test (TUG). This comparison will be made regarding the completion time of the test and the functional score in the Get Up and Go test.
Time frame: inclusion (0)
- using dynamic assessments : Maximum front displacement of the Plantar pressure center (CP) resultant when avoiding the central ball,
Time frame: dynamic avoidance test in 7 days
- Using static assessments : Postural asymmetry obtained by calculating the percentage of body weight distribution on each leg during the static postural initial assessment on force plate
Time frame: Inclusion (0)
The ABS TUG score (being validated) will also be compared to the lateral displacement of the center of mass (CoM).
Time frame: inclusio (0)
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 31 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Avoidance Task, physical therapy and 3D motion on optoelectronic device in people with Hemiplegic Patients, run by Rennes University Hospital 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 14 inclusion and 12 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 31 May 2017. 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?
The primary outcome is the lateral displacement of the center of mass (CoM) in the frontal plane, obtained after recording the 3D motion using an optoelectronic device (time frame: dynamic avoidance test in 7 days). 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 31 May 2017.