A Very Early Standing Study in Elderly Stroke

NCT03424031 | Terminated

• 1 other identifier: CHRO-2016-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• PASS score

  the 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).

  4th month

Secondary Outcomes (4)

• functional recovery

  Day 15

• Evaluation of the walk quality

  Month 4

• Percentage of days with stools

  Day 15

• Semi-quantitative evaluation

  Day 15

Study Arms (2)

Verticalization

EXPERIMENTAL

the patient will be placed in the most vertical position possible.

Procedure: Verticalization

Passive mobilization

NO INTERVENTION

Passive mobilization of the lower limb deficit

Interventions

Verticalization PROCEDURE

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.

Verticalization

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (4)

• 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.

  PMID: 17702703 BACKGROUND

• 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.

  PMID: 11779908 BACKGROUND

• 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.

  PMID: 15929503 BACKGROUND

• 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.

  PMID: 10471437 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Canan OZSANCAK, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 6, 2018
• Study Start: January 31, 2017
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)