Spasticity, LokomatNCT02718053
Reliability of Spasticity Measurement With Lokomat
An observational study of Spasticity, Lokomat, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the reliability of spasticity measurement with Lokomat Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spasticity, Lokomat
- What is being tested?
- L-stiff and Ashworth
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to May 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects are selected from patients hospitalized in our neurorehabilitation unit
Who may be able to join
- patients affected by lower limbs spasticity
Who cannot join
- medical contraindications to mobilization with Lokomat
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Generale di Zona Moriggia Pelascini
Gravedona Ed Uniti, CO, 22015
About this study
The purpose of the study is to evaluate the reliability of spasticity measurement with Lokomat
- Conditions
- Spasticity, Lokomat
- Being tested
- L-stiff, Ashworth
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-stiffOther
spasticity measurement with Lokomat
AshworthOther
spasticity measurement with Ashworth scale
| Study group | Role | What they receive |
|---|---|---|
| spasticity | patients affected by spasticity of the lower limbs Receives: Other: L-stiff; Other: Ashworth | |
| controls | healthy subjects Receives: Other: L-stiff; Other: Ashworth |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of spasticity measurement obtained with L-Stiff (Lokomat) and Ashworth scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, LokomatStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718053
- Sponsor's protocol ID
- spasticity01
- Status last verified
- Sep 2016
- First submitted
- 11 Mar 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Spasticity Measurement With Lokomat
- ClinicalTrials.gov ID
- NCT02718053
- Acronym / sponsor ID
- spasticity01
- Conditions
- Spasticity, Lokomat
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- First posted
- 24 Mar 2016 (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.
The purpose of the study is to evaluate the reliability of spasticity measurement with Lokomat
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spasticity | – | Other: L-stiff, Other: Ashworthpatients affected by spasticity of the lower limbs |
| controls | – | Other: L-stiff, Other: Ashworthhealthy subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects are selected from patients hospitalized in our neurorehabilitation unit
Key inclusion criteria (1 listed)
- patients affected by lower limbs spasticity
Key exclusion criteria (1 listed)
- medical contraindications to mobilization with Lokomat
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 |
|---|---|---|
| L-stiffspasticity measurement with Lokomat | Other | controls, spasticity |
| Ashworthspasticity measurement with Ashworth scale | Other | controls, spasticity |
Primary outcome
correlation of spasticity measurement obtained with L-Stiff (Lokomat) and Ashworth scale
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
Related trials for Spasticity, Lokomat
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?
An observational study of Spasticity, Lokomat, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 30 Sep 2016. 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 Italy. 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?
Results are not available in the source record.
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?
correlation of spasticity measurement obtained with L-Stiff (Lokomat) and Ashworth scale (time frame: 1 day). 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 30 Sep 2016.