Reliability of Spasticity Measurement With Lokomat | NCT02718053

Studies
Reliability of Spasticity Measurement With Lokomat

NCT02718053

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Status

Suspended

Last Update Posted

Sep 30, 2016Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Spasticity, Lokomat

Interventions

L-stiff
Ashworth

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Mar 11, 2016

First Submission Date that Met QC Criteria

Mar 19, 2016

First Posted Date

Mar 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2016

Last Update Posted Date

Sep 30, 2016Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
spasticity		patients affected by spasticity of the lower limbs	Other: L-stiff Other: Ashworth
controls		healthy subjects	Other: L-stiff Other: Ashworth

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-stiff	Other	spasticity measurement with Lokomat	controls spasticity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation of spasticity measurement obtained with L-Stiff (Lokomat) and Ashworth scale		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients affected by lower limbs spasticity

Exclusion Criteria:

medical contraindications to mobilization with Lokomat

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

subjects are selected from patients hospitalized in our neurorehabilitation unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Generale di Zona Moriggia Pelascini		Gravedona Ed Uniti	CO	22015	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009128	Muscle Spasticity

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided