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Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients (ISOKINETIC)

Primary Purpose

Stroke, Hemiplegia, Gait

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isokinetic hip flexors strengthening
Conventional rehabilitation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, gait, hip flexors, paresis, hemiplegia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering from a first ever stroke
  • At the subacute phase
  • Able to walk at least 10m with or without assistive devices
  • Hip flexors strength on the paretic side > 2/5 (MRC)

Exclusion Criteria:

  • Uncontrolled epilepsy
  • Contraindications to physical activity (severe arterial hypertension, aortic valvulopathy, severe PAD...)
  • History of muscular or joint disorders on the paretic hip
  • Subject unable to deliver an informed written consent (due to aphasia, cognitive or psychiatric disorders...)
  • Protected persons
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Isokinetic

    Control

    Arm Description

    Patients who benefit from the hip flexors isokinetic strengthening rehabilitation program

    Patients who benefit from a conventional rehabilitation program

    Outcomes

    Primary Outcome Measures

    Max gait speed (m/s)
    Gait speed will be assessed in the 10m walk test

    Secondary Outcome Measures

    Max gait speed (m/s)
    Gait speed will be assessed in the 10m walk test
    Hip flexors strength
    Hip flexors strength will be evaluated using an isokinetic dynamometer (concentric, 30°/s) and motor testing (medical research council)
    Gait endurance
    Gait endurance will be assessed using the 6MWT
    Gait capacities
    Functional ambulation categories (FAC)
    Balance and postural control
    Postural Assessment for Stroke Scale (PASS)
    Balance and postural control
    Timed-up and go test
    Rate of perceived exhaustion during gait
    Borg scale

    Full Information

    First Posted
    September 22, 2016
    Last Updated
    September 11, 2018
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02917850
    Brief Title
    Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
    Acronym
    ISOKINETIC
    Official Title
    Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    sponsor decision
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Post-stroke patients often present with gait disorders due to several physical impairments. Hip flexor deficit is one of the more prevalent trouble and is associated with gait capacities. This study aims at evaluating the impact of an isokinetic hip flexors strengthening rehabilitation program in the subacute phase after stroke. Patients will be randomized to an intervention group (isokinetic rehabilitation) or a control group (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and at 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Hemiplegia, Gait
    Keywords
    stroke, gait, hip flexors, paresis, hemiplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Isokinetic
    Arm Type
    Active Comparator
    Arm Description
    Patients who benefit from the hip flexors isokinetic strengthening rehabilitation program
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients who benefit from a conventional rehabilitation program
    Intervention Type
    Procedure
    Intervention Name(s)
    Isokinetic hip flexors strengthening
    Intervention Description
    Isokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional rehabilitation
    Intervention Description
    Conventional rehabilitation 10/w during 6 weeks
    Primary Outcome Measure Information:
    Title
    Max gait speed (m/s)
    Description
    Gait speed will be assessed in the 10m walk test
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Max gait speed (m/s)
    Description
    Gait speed will be assessed in the 10m walk test
    Time Frame
    3 and 6 months
    Title
    Hip flexors strength
    Description
    Hip flexors strength will be evaluated using an isokinetic dynamometer (concentric, 30°/s) and motor testing (medical research council)
    Time Frame
    6weeks; 3 and 6 months
    Title
    Gait endurance
    Description
    Gait endurance will be assessed using the 6MWT
    Time Frame
    6 weeks; 3 and 6 months
    Title
    Gait capacities
    Description
    Functional ambulation categories (FAC)
    Time Frame
    6 weeks; 3 and 6 months
    Title
    Balance and postural control
    Description
    Postural Assessment for Stroke Scale (PASS)
    Time Frame
    6 weeks; 3 and 6 months
    Title
    Balance and postural control
    Description
    Timed-up and go test
    Time Frame
    6 weeks; 3 and 6 months
    Title
    Rate of perceived exhaustion during gait
    Description
    Borg scale
    Time Frame
    6 weeks; 3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suffering from a first ever stroke At the subacute phase Able to walk at least 10m with or without assistive devices Hip flexors strength on the paretic side > 2/5 (MRC) Exclusion Criteria: Uncontrolled epilepsy Contraindications to physical activity (severe arterial hypertension, aortic valvulopathy, severe PAD...) History of muscular or joint disorders on the paretic hip Subject unable to deliver an informed written consent (due to aphasia, cognitive or psychiatric disorders...) Protected persons Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Etienne Allart, MD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients

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