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A Very Early Standing Study in Elderly Stroke

A Very Early Standing Study in Elderly Stroke

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03424031
Acronym
AVESSES
Enrollment
45
Registered
2018-02-06
Start date
2017-01-31
Completion date
2020-07-10
Last updated
2020-11-06

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

Conditions

Stroke

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.

Interventions

To allow the verticalization of hemiplegic patients, we will use a device commonly used in rehabilitation: the standing (or standing) brand Thera Trainer . This device makes it possible to keep the patient standing despite the motor and postural deficits thanks to knee, buttocks and an anterior support for the upper limbs. Verticalization with this device requires the presence of one or two caregivers (including at least one re-educator), depending on the possibilities of participation of the patient.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PASS score4th monththe PASS score (score of 36) will be evaluated at 4 months (t2) in single blind (by a physiotherapist who will not be aware of the reeducation performed).

Secondary

MeasureTime frameDescription
functional recoveryDay 15It will be performed in single blind by evaluating the PASS score after the 10th session (t1) or when the patient leaves if it occurs before.
Evaluation of the walk qualityMonth 4It will be performed in single blind thanks to the modified FAC scale at 4 month
Percentage of days with stoolsDay 15Number of days with stool / number of days of hospitalization in UNV
Semi-quantitative evaluationDay 15The amount of stool is evaluated in the data collection of the care teams (0: no saddle, +: small amount of stool, ++: moderate amount, +++: larger quantity, ++ ++: very important quantity)

Countries

France

Outcome results

None listed

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