NCT01520636

Brief Summary

This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2020

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

January 18, 2012

Last Update Submit

January 17, 2020

Conditions

Rehabilitation

Keywords

strokeearly rehabilitationmotor recoveryfunctional recovery

Outcome Measures

Primary Outcomes (1)

  • Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK

    between day 0 and month 3

Secondary Outcomes (8)

  • Motor control deficiency assessed by the FM scale

    at D15, D30, D45, M3

  • Total length of stay as inpatient

    up to D30

  • Autonomy assessed by the Functional Independence Measure (motor subscale)

    at D30 and M3

  • Autonomy assessed by the Rankin scale

    at D15, D30, D45, M3.

  • Unexpected events

    at D30 and M3

  • +3 more secondary outcomes

Study Arms (2)

group 1: standard physiotherapy

PLACEBO COMPARATOR

daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day.

Procedure: standard physiotherapy

group 2: experimental physiotherapy

EXPERIMENTAL

physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.

Procedure: experimental physiotherapy

Interventions

standard physiotherapyPROCEDURE

daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day

group 1: standard physiotherapy
experimental physiotherapyPROCEDURE

physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.

group 2: experimental physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients informed and giving their written consent.First
  • Ever ischemic hemispheric or haemorrhagic stroke, unilateral, occurred between the 25th and the 72nd previous hours
  • Age ≥ 18 years old
  • Motricity quoted by an NIHSS \>=2 in the upper limb or in the lower limb

You may not qualify if:

  • Patient without health insurance.
  • Coma (NIHSS consciousness \> or = 2)
  • Total recovery within the 24 first hours
  • Brain stem or cerebellar stroke
  • Previous neurological history, specially stroke or dementia
  • Inability to understand the study
  • Surgical treatment of the stroke
  • Autonomy before stroke assessed by Rankin score different from 0
  • Scheduled surgery in the following 15 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de MPR - Hôpital Fernand Widal

Paris, 75010, France

Location

Service de Neurologie - Hôpital Lariboisière

Paris, 75010, France

Location

Related Publications (1)

  • Yelnik AP, Quintaine V, Andriantsifanetra C, Wannepain M, Reiner P, Marnef H, Evrard M, Meseguer E, Devailly JP, Lozano M, Lamy C, Colle F, Vicaut E; AMOBES Group. AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22.

    PMID: 28008092RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Alain YELNIK, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 30, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

January 22, 2020

Record last verified: 2017-04

Locations

FR(2)