Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03666338

Acronym

SOMS-GCS

Enrollment

200

Registered

2018-09-11

Start date

2011-07-11

Completion date

2016-02-04

Last updated

2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Rehabilitation

Keywords

early mobilization

Brief summary

Analysis of the randomized controlled SOMS trial of early, goal-directed mobilization to investigate if the treatment effect is consistent and independent of the initial conscious state without evidence of moderation or modification.

Interventions

OTHEREarly, goal-directed mobilization

Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* aged 18 years or older * mechanically ventilated for less than 48 h and expected to require mechanical ventilation for at least another 24 h at the time of screening * functionally independent at baseline with a Barthel Index Score of at least 70 at 2 weeks before admission to the ICU based on patient or proxy completion of the measure

Exclusion criteria

* admitted to hospital for more than 5 days before screening * a motor component of Glasgow Coma Scale (GCS) lower than 5 * irreversible disorder with a 6-month mortality of greater than 50%, * raised intracranial pressure * cardiopulmonary arrest * unstable fractures contributing to probable immobility * inclusion in another trial at the same time * acute myocardial infarction * do not have lower part of their legs * have a rapidly developing neuromuscluar disease * pregnant * ruptured or leaking aortic aneurysm

Design outcomes

Primary

Measure	Time frame	Description
Functional independence at hospital discharge	At the day of hospital discharge, on average up to 1 month	minimal modified functional independence measure score of 8 (Scale ranging from 0-8 with the subdomain locomotion and transfer 0-4 each)

Secondary

Measure	Time frame	Description
average achieved mobility level during the ICU stay	from ICU admission to ICU discharge, on average up to 2 weeks	mean achieved SOMS level
Functional status at hospital discharge	At the day of hospital discharge, on average up to 1 month	minimal modified functional independence measure score (range 0-8) of the subdomains transfer and locomotion with 0-4 each
Start to mobilization (SOMS > 0)	Days from ICU admission till first mobilization, approximately up to 5 days	Start to mobilization in days (Surgical Optimal Mobilization Scale \> 0, ranging from 0 = no mobilization to 4 ambulation)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026