We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified August 2017 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT02917850
First Posted: September 28, 2016
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
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 Intervention
Stroke Hemiplegia Gait Procedure: Isokinetic hip flexors strengthening Procedure: Conventional rehabilitation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

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


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

  • 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)

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

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

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

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

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


Estimated Enrollment: 40
Actual Study Start Date: August 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Etienne Allart, MD etienne.allart@chru-lille.fr

Locations
France
CRF L'espoir Recruiting
Hellemmes, France
Contact: Alexandre Coulomb, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Etienne Allart, MD University Hospital, Lille
  More Information

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 Submitted: September 22, 2016
First Posted: September 28, 2016
Last Update Posted: August 23, 2017
Last Verified: August 2017
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