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RehabilitationAMOBESNCT01520636

Active MOBility Early After Stroke : What Should be the Best Physiotherapy Early After Stroke ?

A study testing standard physiotherapy and experimental physiotherapy in people with Rehabilitation, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rehabilitation
What is being tested?
standard physiotherapy and experimental physiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
2 sitesFrance
Study dates
Jul 2012to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Surgical treatment of the stroke
  • Autonomy before stroke assessed by Rankin score different from 0
  • Scheduled surgery in the following 15 days

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Service de MPR - Hôpital Fernand Widal

    Paris, 75010

  • Service de Neurologie - Hôpital Lariboisière

    Paris, 75010

Other trials in France

About this study

Official title: What Should be the Best Physiotherapy Early After Stroke ?

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.

Read the detailed description

Hypothesis:

An intensive and active physiotherapy delivered as soon as D2 post stroke could induce faster motor control recovery and autonomy than could do an usual conservative treatment aiming at preventing complications. The benefits could be a shortened inpatient stay (both in stroke unit and rehabilitation centre), a reduction of the secondary complications with a cut in of the total cost of care.

Primary objective:

To compare two strategies of physiotherapy on the evolution of motor control recovery during the first 3 months post stroke.

Secondary objectives :

To compare two strategies of physiotherapy on:

  • Motor control deficiency on D15, D30, D45, M3
  • Total length of stay as inpatient
  • Autonomy on D15, D30, D45, M3
  • Frequency of unexpected events
  • Quality of life on M3
  • Living place on M3

Assessment criteria:

-First criterion : Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK between day 0 and month 3.-Secondary criteria :

  • Motor control deficiency assessed by the FM scale on D15, D30, D45, M3 and by the time requested before being able to walk 10 meters without human assistance.
  • Total length of stay as inpatient
  • Autonomy assessed by the Functional Independence Measure (motor subscale) on D30 and M3 and by the Rankin scale on D15, D30, D45, M3.
  • Unexpected events recorded on D30 and M3
  • Quality of life assessed by the Stroke Impact Scale on M3
  • Residency

Method:

This is a "Zelen", single-blinded, randomised, controlled, multicentric trial aiming at comparing intensive physiotherapy after a stroke with the usually more conservative physiotherapy provided. Treatment is applied from the inclusion to the end of the stroke unit stay or until D15 post stroke.

  • Group 1: 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 2: 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.
Conditions
Rehabilitation
Being tested
standard physiotherapy, experimental physiotherapy
Keywords
stroke, early rehabilitation, motor recovery, functional recovery
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard physiotherapyProcedure or surgery

    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

  • experimental physiotherapyProcedure or surgery

    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.

Study groups in NCT01520636
Study groupRoleWhat they receive
group 1: standard physiotherapyPlacebo comparatordaily 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.
Receives: Procedure: standard physiotherapy
group 2: experimental physiotherapyExperimentalphysiotherapy 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.
Receives: Procedure: experimental physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: between day 0 and month 3

Secondary outcomes (8)

  1. Motor control deficiency assessed by the FM scale

    Motor control deficiency assessed by the FM scale on D15, D30, D45, M3 and by the time requested before being able to walk 10 meters without human assistance.

    Measured: at D15, D30, D45, M3

  2. Total length of stay as inpatient

    Total length of stay as inpatient

    Measured: up to D30

  3. Autonomy assessed by the Functional Independence Measure (motor subscale)

    Measured: at D30 and M3

  4. Autonomy assessed by the Rankin scale

    Measured: at D15, D30, D45, M3.

  5. Unexpected events

    Unexpected events recorded on D30 and M3

    Measured: at D30 and M3

  6. Quality of life assessed by the Stroke Impact Scale

    Quality of life assessed by the Stroke Impact Scale on M3

    Measured: at M3

  7. Residency

    Measured: at M3

  8. Scale PASS

    Evaluation scale of balance PASS at D30 and M3

    Measured: at D30 and M3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMar 2015
  4. Study completionDec 2015

Why it stopped: difficulty of inclusion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01520636
Sponsor's protocol ID
P100124
Other IDs
2011-A01049-32
Acronym
AMOBES
Status last verified
Apr 2017
First submitted
18 Jan 2012
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28008092

Questions about this trial

What is this clinical trial studying?

A study testing standard physiotherapy and experimental physiotherapy in people with Rehabilitation, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: difficulty of inclusion). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (time frame: between day 0 and month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01520636, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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