Clinical trial NCT03424031: A Very Early Standing Study in Elderly Stroke
Official title: A Very Early Standing Study in Elderly Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 45
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery.

Verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. Although commonly used in the rehabilitation of stroke, evidence is still lacking as to its impact in this specific care.

Verticalization is underutilized in two situations: in the hyper acute phase as well as in elderly and very deficient patients. It has, however, been shown that the precocity of the treatment allows a better functional recovery. Similarly, the re-education of the elderly is also debated since it has long been mentioned that age was a factor of poor prognosis, the objectives are sometimes underestimated. However, several studies have shown that with the same rehabilitation, elderly patients recover as much as younger patients. The differences found are at least in part due to "less rehabilitation" of older stroke patients.

The different existing data lead us to the hypothesis that the verticalization of the elderly hemiplegic patient in acute phase would allow a better functional recovery.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Age \> 70
* Modified Rankin Scale (MRS) pre stroke : 0 or 1
* Admission in the neuro vascular unit less than 48 hours after the onset of symptoms
* NIHSS Item 6 for lower extremity motor skills: 3 or 4
* Modified Functional Ambulation Classification : 0
* Affiliated to a social security scheme

Exclusion Criteria:

* History of stroke with motor sequencing limiting walking
* Arterial stenosis limiting the sunrise before D4 (identified by Doppler)
* Symptomatic orthostatic hypotension known or present in the acute phase
* Coma
* Patients who will be referred to a structure (UNV or other) outside the department
* Fracture, orthopedic disorder or any other complication preventing verticalization
* Refusal of the patient to participate in the study or to be verticalized
* Patients under guardianship
* Patients deprived of their liberty by an administrative decision

Primary outcomes:
measure: PASS score
timeFrame: 4th month
Secondary outcomes:
measure: functional recovery
timeFrame: Day 15
measure: Evaluation of the walk quality
timeFrame: Month 4
measure: Percentage of days with stools
timeFrame: Day 15
measure: Semi-quantitative evaluation
timeFrame: Day 15
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR d'Orléans
name: Canan OZSANCAK, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allison R, Dennett R. Pilot randomized controlled trial to assess the impact of additional supported standing practice on functional ability post stroke. Clin Rehabil. 2007 Jul;21(7):614-9. doi: 10.1177/0269215507077364.
citation: Bagg S, Pombo AP, Hopman W. Effect of age on functional outcomes after stroke rehabilitation. Stroke. 2002 Jan;33(1):179-85. doi: 10.1161/hs0102.101224.
citation: Bagley P, Hudson M, Forster A, Smith J, Young J. A randomized trial evaluation of the Oswestry Standing Frame for patients after stroke. Clin Rehabil. 2005 Jun;19(4):354-64. doi: 10.1191/0269215505cr874oa.
citation: Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.