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

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ClinicalTrials.gov Identifier: NCT02917850
Recruitment Status : Withdrawn (sponsor decision)
First Posted : September 28, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Gait Procedure: Isokinetic hip flexors strengthening Procedure: Conventional rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Isokinetic
Patients who benefit from the hip flexors isokinetic strengthening rehabilitation program
Procedure: Isokinetic hip flexors strengthening
Isokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w.

Procedure: Conventional rehabilitation
Conventional rehabilitation 10/w during 6 weeks

Active Comparator: Control
Patients who benefit from a conventional rehabilitation program
Procedure: Conventional rehabilitation
Conventional rehabilitation 10/w during 6 weeks




Primary Outcome Measures :
  1. Max gait speed (m/s) [ Time Frame: 6 weeks ]
    Gait speed will be assessed in the 10m walk test


Secondary Outcome Measures :
  1. Max gait speed (m/s) [ Time Frame: 3 and 6 months ]
    Gait speed will be assessed in the 10m walk test

  2. Hip flexors strength [ Time Frame: 6weeks; 3 and 6 months ]
    Hip flexors strength will be evaluated using an isokinetic dynamometer (concentric, 30°/s) and motor testing (medical research council)

  3. Gait endurance [ Time Frame: 6 weeks; 3 and 6 months ]
    Gait endurance will be assessed using the 6MWT

  4. Gait capacities [ Time Frame: 6 weeks; 3 and 6 months ]
    Functional ambulation categories (FAC)

  5. Balance and postural control [ Time Frame: 6 weeks; 3 and 6 months ]
    Postural Assessment for Stroke Scale (PASS)

  6. Balance and postural control [ Time Frame: 6 weeks; 3 and 6 months ]
    Timed-up and go test

  7. Rate of perceived exhaustion during gait [ Time Frame: 6 weeks; 3 and 6 months ]
    Borg scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917850


Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Etienne Allart, MD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02917850     History of Changes
Other Study ID Numbers: 2015_32
2016-A00366-45 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
stroke
gait
hip flexors
paresis
hemiplegia

Additional relevant MeSH terms:
Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms