<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02202954</url>
  </required_header>
  <id_info>
    <org_study_id>P100114</org_study_id>
    <secondary_id>2012-A00348-35</secondary_id>
    <nct_id>NCT02202954</nct_id>
  </id_info>
  <brief_title>Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke</brief_title>
  <acronym>NEURORESTORE</acronym>
  <official_title>Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke. Efficacy and Cost After One Year Treatment. A Randomized, Controlled, Multicenter, Single Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the situation of motor limitations that people often experience after stroke, current&#xD;
      health systems cannot provide for the daily amount and duration of high intensity muscle&#xD;
      stretch and motor training that would be required over protracted periods to involve muscle&#xD;
      and brain plasticity. For patients with sufficient cognitive abilities, Guided&#xD;
      Self-rehabilitation Contracts allow implementing stretch and training at high intensity and&#xD;
      may result in meaningful functional improvement in chronic stages, as long as discipline&#xD;
      persists over at least a year span.&#xD;
&#xD;
      This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as&#xD;
      against conventional therapy in the community, for a one year duration in persons with&#xD;
      chronic hemiparesis after stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single blind controlled multicentre protocol will compare the evolution after a one-year&#xD;
      treatment, either using a Guided Self-rehabilitation Contract or conventional therapy in the&#xD;
      community. Patients with chronic stroke-induced hemiparesis (over a year post stroke) will be&#xD;
      selected to be randomized between the two groups, Conventional or in Guided&#xD;
      Self-rehabilitation Contracts.&#xD;
&#xD;
      In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense,&#xD;
      providing double guidance:&#xD;
&#xD;
        -  Technical, selecting and teaching the required exercises to the patient using infrequent&#xD;
           thorough visits, for example every month.&#xD;
&#xD;
        -  Psychological, binding with the patient on the contract.&#xD;
&#xD;
      The patient agrees to:&#xD;
&#xD;
        -  Perform the prescribed daily stretch postures and rapid alternating movements over the&#xD;
           long term.&#xD;
&#xD;
        -  Document this work in a written diary.&#xD;
&#xD;
      To facilitate such contracts, a manual for guided self-rehabilitation in spastic paresis has&#xD;
      been developed and will be provided to patients randomized to that group.&#xD;
&#xD;
      124 patients will be enrolled from 6 centers in France: Creteil, Paris Fernand-Widal,&#xD;
      Toulouse, Reims, Saint-Etienne and Bordeaux. The duration of patient participation will be 2&#xD;
      years: 6 months follow-up, 1 year intervention and another 6-month follow-up after the study&#xD;
      intervention. Only functional assessments will be used, using in particular ambulation speed&#xD;
      for the lower limb and the Modified FRENCHAY Scale for the upper limb.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)</measure>
    <time_frame>After one year of treatment</time_frame>
    <description>Fast 10-meter barefoot ambulation speed with no assistive device&#xD;
Active upper limb function using the Modified FRENCHAY scale (10 everyday life activities performed live in front of the investigator and videotaped - videos reviewed later by a blinded investigator).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Speed, step length and cadence over 10 meters at comfortable speed, barefoot and with shoes, with no assistive device</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speed, step length, cadence and physiological cost index over 2 minutes at maximal speed, with shoes</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Assessment Scale: interview between patient and investigator, assessing the level of disability in 4 domains (dressing, cosmesis, hygiene and pain)</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Activity of Daily Living (ADL) Index</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euro-Qol - 5 dimension (EQ-5D)</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
    <description>European Quality of Life Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale - 15</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire to the patient (or caregiver) evaluating monthly frequency of physical therapy sessions and amount of home aid during the whole study period, that will serve as basis for a cost evaluation from the point of view of medical insurance.</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of the total cost of care, including medical costs, social expenses, amount of social benefits, from the point of view of the medical insurance and of the state, to include all payors.</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation by the occupational therapist of home adaptation and the functioning at home</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
    <description>An ancillary study on the 44 patients in the Paris area</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation by a clinical psychologist of coping with each type of care (guided self-rehabilitation or conventional), of the required psychological resources and the potential need for psychological follow-up.</measure>
    <time_frame>One assessment visit every 6 month for 2 years</time_frame>
    <description>An ancillary study on the 44 patients in the Paris area.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Hemiparesis</condition>
  <arm_group>
    <arm_group_label>Guided Self-rehabilitation Contract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.&#xD;
The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional rehabilitation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>conventional therapy in the community</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Guided Self-rehabilitation Contract</intervention_name>
    <description>In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.&#xD;
The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.</description>
    <arm_group_label>Guided Self-rehabilitation Contract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with spastic hemiparesis, following a unique stroke episode over a year before&#xD;
             enrollment into the study&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Barefoot walking possible with no assistive device over 10 m&#xD;
&#xD;
          -  Fast barefoot ambulation speed between 0.1 m/sec and 1.3 m/sec&#xD;
&#xD;
          -  Mean Modified FRENCHAY Score between 2 and 8/10&#xD;
&#xD;
          -  Patient having provided a signed consent to participate in this trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple stroke episodes, clinically of based on brain imaging&#xD;
&#xD;
          -  No recent (less than 3 months before enrollment) brain imaging (CT scan or MRI) in&#xD;
             case of doubt about multiple stroke episodes&#xD;
&#xD;
          -  Concurrent severe condition jeopardizing functional or vital prognosis, or the ability&#xD;
             to participate in rehabilitation sessions&#xD;
&#xD;
          -  Cognitive, phasic or behavioral condition impeding verbal communication, active&#xD;
             participation to a rehabilitation or self-rehabilitation program, or participation in&#xD;
             a research study, according to the investigator's judgment&#xD;
&#xD;
          -  Person having a tutor or benefiting from a law protection order&#xD;
&#xD;
          -  Person not benefiting from French State Health Insurance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Michel GRACIES, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henri Mondor Hospital</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.neuroloco.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>June 19, 2017</last_update_submitted>
  <last_update_submitted_qc>June 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Muscle Spasticity</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202954
org study id: P100114
secondary id: 2012-A00348-35
nct id: NCT02202954
lead sponsor: 
has dmc: Yes
In the situation of motor limitations that people often experience after stroke, current
      health systems cannot provide for the daily amount and duration of high intensity muscle
      stretch and motor training that would be required over protracted periods to involve muscle
      and brain plasticity. For patients with sufficient cognitive abilities, Guided
      Self-rehabilitation Contracts allow implementing stretch and training at high intensity and
      may result in meaningful functional improvement in chronic stages, as long as discipline
      persists over at least a year span.

      This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as
      against conventional therapy in the community, for a one year duration in persons with
      chronic hemiparesis after stroke.
This single blind controlled multicentre protocol will compare the evolution after a one-year
      treatment, either using a Guided Self-rehabilitation Contract or conventional therapy in the
      community. Patients with chronic stroke-induced hemiparesis (over a year post stroke) will be
      selected to be randomized between the two groups, Conventional or in Guided
      Self-rehabilitation Contracts.

      In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense,
      providing double guidance:

        -  Technical, selecting and teaching the required exercises to the patient using infrequent
           thorough visits, for example every month.

        -  Psychological, binding with the patient on the contract.

      The patient agrees to:

        -  Perform the prescribed daily stretch postures and rapid alternating movements over the
           long term.

        -  Document this work in a written diary.

      To facilitate such contracts, a manual for guided self-rehabilitation in spastic paresis has
      been developed and will be provided to patients randomized to that group.

      124 patients will be enrolled from 6 centers in France: Creteil, Paris Fernand-Widal,
      Toulouse, Reims, Saint-Etienne and Bordeaux. The duration of patient participation will be 2
      years: 6 months follow-up, 1 year intervention and another 6-month follow-up after the study
      intervention. Only functional assessments will be used, using in particular ambulation speed
      for the lower limb and the Modified FRENCHAY Scale for the upper limb.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)
time frame: After one year of treatment
description: Fast 10-meter barefoot ambulation speed with no assistive device
Active upper limb function using the Modified FRENCHAY scale (10 everyday life activities performed live in front of the investigator and videotaped - videos reviewed later by a blinded investigator).
measure: Speed, step length and cadence over 10 meters at comfortable speed, barefoot and with shoes, with no assistive device
time frame: One assessment visit every 6 month for 2 years
measure: Speed, step length, cadence and physiological cost index over 2 minutes at maximal speed, with shoes
time frame: One assessment visit every 6 month for 2 years
measure: Disability Assessment Scale: interview between patient and investigator, assessing the level of disability in 4 domains (dressing, cosmesis, hygiene and pain)
time frame: One assessment visit every 6 month for 2 years
measure: Barthel Activity of Daily Living (ADL) Index
time frame: One assessment visit every 6 month for 2 years
measure: Euro-Qol - 5 dimension (EQ-5D)
time frame: One assessment visit every 6 month for 2 years
description: European Quality of Life Scale
measure: Geriatric Depression Scale - 15
time frame: One assessment visit every 6 month for 2 years
measure: Questionnaire to the patient (or caregiver) evaluating monthly frequency of physical therapy sessions and amount of home aid during the whole study period, that will serve as basis for a cost evaluation from the point of view of medical insurance.
time frame: One assessment visit every 6 month for 2 years
measure: Estimation of the total cost of care, including medical costs, social expenses, amount of social benefits, from the point of view of the medical insurance and of the state, to include all payors.
time frame: One assessment visit every 6 month for 2 years
measure: Evaluation by the occupational therapist of home adaptation and the functioning at home
time frame: One assessment visit every 6 month for 2 years
description: An ancillary study on the 44 patients in the Paris area
measure: Evaluation by a clinical psychologist of coping with each type of care (guided self-rehabilitation or conventional), of the required psychological resources and the potential need for psychological follow-up.
time frame: One assessment visit every 6 month for 2 years
description: An ancillary study on the 44 patients in the Paris area.
arm group label: Guided Self-rehabilitation Contract
arm group type: Active Comparator
description: In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.
The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.
arm group label: Conventional rehabilitation
arm group type: No Intervention
description: conventional therapy in the community
intervention type: Other
intervention name: Guided Self-rehabilitation Contract
description: In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.
The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.
arm group label: Guided Self-rehabilitation Contract
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Michel GRACIES, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
url: http://www.neuroloco.org
description: Related Info
responsible party type: Sponsor
mesh term: Paresis