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

September 11, 2018 updated by: University Hospital, Lille
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Max gait speed (m/s)
Time Frame: 6 weeks
Gait speed will be assessed in the 10m walk test
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Max gait speed (m/s)
Time Frame: 3 and 6 months
Gait speed will be assessed in the 10m walk test
3 and 6 months
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)
6weeks; 3 and 6 months
Gait endurance
Time Frame: 6 weeks; 3 and 6 months
Gait endurance will be assessed using the 6MWT
6 weeks; 3 and 6 months
Gait capacities
Time Frame: 6 weeks; 3 and 6 months
Functional ambulation categories (FAC)
6 weeks; 3 and 6 months
Balance and postural control
Time Frame: 6 weeks; 3 and 6 months
Postural Assessment for Stroke Scale (PASS)
6 weeks; 3 and 6 months
Balance and postural control
Time Frame: 6 weeks; 3 and 6 months
Timed-up and go test
6 weeks; 3 and 6 months
Rate of perceived exhaustion during gait
Time Frame: 6 weeks; 3 and 6 months
Borg scale
6 weeks; 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_32
  • 2016-A00366-45 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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