Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study (ERASM)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Stroke

Treatments

Procedure: Occupational therapy
Procedure: Functional near-infrared spectroscopy
Procedure: Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02664636
LOCAL/2015/JF-02
2015-A01624-45 (Other Identifier)

Details and patient eligibility

About

The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.

Full description

The secondary objectives of this study are: A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from Day 0 to Day 60. B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.

Enrollment

10 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion

Exclusion criteria

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient presents with a severe cognitive disorder
  • The patient has severe aphasia with a Boston Diagnostic Aphasia Examination (BDAE) scale score strictly less than 2
  • The patient has heminegligence with a bells test > 6 on the left.
  • The patient presents with limited amplitude in the paretic upper limb (shoulder abduction <60°, elbow flexion > 30° or dorsal wrist flexion <20°).
  • Imbalanced/uncontrolled epilepsy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

The study population
Experimental group
Description:
The study population consists of patients 20 and 75 years of age who have had a supra-tentorial ischemic or hemorrhagic stroke. The study covers consulting or hospitalized patients at the neurological rehabilitation service (NHS) of Grau du Roi Medical Center, part of the Nîmes University Hospital. Most patients originate from a 2-4 week stay in the neurological acute care, cardiac or polyvalent departments of the University Hospitals of Montpellier or Nîmes. Intervention: Physiotherapy Intervention: Occupational therapy Intervention: Functional near-infrared spectroscopy
Treatment:
Procedure: Physiotherapy
Procedure: Functional near-infrared spectroscopy
Procedure: Occupational therapy

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems