Acquired Brain Injury Clinical Trial
Official title:
Effects of Early Stepping Verticalization With or Without FES Compared to Conventional Physiotherapy on the Occurrence of Critical Illness Polyneuropathy in Patients Affected by Acquired Brain Injury: a Retrospective Study
Verified date | August 2018 |
Source | Ospedale Generale Di Zona Moriggia-Pelascini |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Intensive Care Unit (ICU) survivors often develop an acquired weakness due to a
Critical Illness Polyneuropathy (CIP). Early mobilization in ICU, by reducing the bed rest
and decreasing the oxidative stress, was shown to represent a valid preventive option.
Purpose: To evaluate whether ICU sessions of stepping verticalization associated with
Functional Electrical Stimulation (FES) of the lower limbs are able to reduce the occurrence
of CIP in Acquired Brain Injured (ABI) patients.
Methods: all the ABI patients admitted in our Neurorehabilitation Unit from our ICU were
retrospectively evaluated. Patients affected by previous peripheral neuropathy, diabetes,
cancer, alcoholism, viral hepatitis, AIDS and autoimmune diseases were excluded. They were
divided into 3 groups according to the rehabilitation strategy received in ICU: group 1
received conventional physiotherapy + stepping verticalization sessions with Erigo® (Hocoma,
Switzerland); group 2 received conventional physiotherapy + stepping verticalization sessions
with FES using ErigoPro®; group 3 received only conventional physiotherapy. As for internal
protocol, all patients started rehabilitation in the first week from the ABI and performed 60
minutes/day of rehabilitation, 5 days/week. Primary outcome was the evidence of CIP at
Neurorehabilitation admission (=ICU discharge), according to neurophysiological criteria.
Secondary outcomes were the strength impairment at Neurorehabilitation discharge, measured by
the total Motricity Index score and the Functional Ambulation Classification (FAC) score,
assessing quality of gait.
Status | Completed |
Enrollment | 39 |
Est. completion date | July 1, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - arriving directly from our acute care facility - hospitalized in ICU due to an acute brain injury Exclusion Criteria: - previous peripheral neuropathies - diabetes - cancer - alcoholism - viral hepatitis - AIDS - autoimmune diseases - absence of clinical or neurophysiological informations at data collection |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Generale di Zona Moriggia Pelascini | Gravedona | CO |
Lead Sponsor | Collaborator |
---|---|
Ospedale Generale Di Zona Moriggia-Pelascini |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CIP occurrence | Presence of critical illness polyneuropathy at the end of ICU stay | at enrollment | |
Secondary | motricity index | total motricity index score (4 limbs) at neurorehabilitation discharge. Score goes from 0 (no movement in any limb) to 400 (full strength in alla limbs) | at enrollment | |
Secondary | Functional Ambulation Classification (FAC) | Functional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation) | at enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03911752 -
Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage
|
||
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Not yet recruiting |
NCT05863897 -
e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
|
N/A | |
Completed |
NCT02215590 -
Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims
|
N/A | |
Recruiting |
NCT05443542 -
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
|
N/A | |
Recruiting |
NCT05309005 -
Virtual Reality and Social Cognition After Acquired Brain Injury
|
||
Recruiting |
NCT04586842 -
Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury
|
N/A | |
Completed |
NCT03328221 -
Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury
|
||
Active, not recruiting |
NCT05734183 -
Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness
|
N/A | |
Active, not recruiting |
NCT05729165 -
Local Vibration in Patients With Severe Acquired Brain Injury
|
N/A | |
Recruiting |
NCT05440682 -
Connectivity in Cranioplasty
|
N/A | |
Completed |
NCT04206475 -
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
|
N/A | |
Recruiting |
NCT02495558 -
Cough Assessment in Patients With Severe Acquired Brain Injury
|
N/A | |
Completed |
NCT03989388 -
Occupational Self-Analysis Programme
|
N/A | |
Terminated |
NCT01974635 -
Proprioception Testing in Persons With Sensorimotor Impairment
|
N/A | |
Not yet recruiting |
NCT01451242 -
The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER
|
N/A | |
Completed |
NCT05052905 -
VR-based Remote Rehabilitation for Pediatric ABI
|
N/A | |
Recruiting |
NCT06130735 -
Impact of Intensive Computerized Cognitive Training
|
N/A | |
Recruiting |
NCT04328857 -
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
|
N/A | |
Completed |
NCT04499092 -
COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery
|
N/A |