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Withdrawn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
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, gait, hip flexors, paresis, hemiplegia
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
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
NCT ID
NCT02917850
First Posted
September 22, 2016
Last Updated
September 11, 2018
Sponsor
University Hospital, Lille
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
Learn more about this trial
Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
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