NCT02455232

Brief Summary

The aim of this study is to determinate what are the main muscles regularly involved in the spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow flexors. Three selective motor block nerves will be carry out in order to assess the gain of the range of motion (passive and active) of the elbow after each Motor Block Nerve.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

May 7, 2015

Last Update Submit

January 30, 2017

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (1)

  • angles of elbow as measured by means of a goniometer

    60 minutes

Study Arms (1)

hemiplegic patient

EXPERIMENTAL

muscle participation in upper limb spasticity

Procedure: upper limb muscle blockDrug: 4cc of lidocaïne®

Interventions

upper limb muscle blockPROCEDURE
hemiplegic patient
4cc of lidocaïne®DRUG
hemiplegic patient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written consent
  • Hemiplegic patient with spasticity and deformation of elbow

You may not qualify if:

  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincaré

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • François Genet, PhD

    Centre d'Investigation Clinique et Technologique 805

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2015

Study Completion

January 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

FR(1)