StrokeISOKINETICNCT02917850
Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
A study testing Isokinetic hip flexors strengthening and Conventional rehabilitation in people with Stroke and Hemiplegia, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia, Gait
- What is being tested?
- Isokinetic hip flexors strengthening and Conventional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
- Conditions
- Stroke, Hemiplegia, Gait
- Being tested
- Isokinetic hip flexors strengthening, Conventional rehabilitation
- Keywords
- stroke, gait, hip flexors, paresis, hemiplegia
- Medical subject headings
- Stroke, Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic hip flexors strengtheningProcedure or surgery
Isokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w.
Conventional rehabilitationProcedure or surgery
Conventional rehabilitation 10/w during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Isokinetic | Active comparator | Patients who benefit from the hip flexors isokinetic strengthening rehabilitation program Receives: Procedure: Isokinetic hip flexors strengthening; Procedure: Conventional rehabilitation |
| Control | Active comparator | Patients who benefit from a conventional rehabilitation program Receives: Procedure: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max gait speed (m/s)
Gait speed will be assessed in the 10m walk test
Measured: 6 weeks
Secondary outcomes (7)
Max gait speed (m/s)
Gait speed will be assessed in the 10m walk test
Measured: 3 and 6 months
Hip flexors strength
Hip flexors strength will be evaluated using an isokinetic dynamometer (concentric, 30°/s) and motor testing (medical research council)
Measured: 6weeks; 3 and 6 months
Gait endurance
Gait endurance will be assessed using the 6MWT
Measured: 6 weeks; 3 and 6 months
Gait capacities
Functional ambulation categories (FAC)
Measured: 6 weeks; 3 and 6 months
Balance and postural control
Postural Assessment for Stroke Scale (PASS)
Measured: 6 weeks; 3 and 6 months
Balance and postural control
Timed-up and go test
Measured: 6 weeks; 3 and 6 months
Rate of perceived exhaustion during gait
Borg scale
Measured: 6 weeks; 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Allart, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917850
- Sponsor's protocol ID
- 2015_32
- Other IDs
- 2016-A00366-45
- Acronym
- ISOKINETIC
- Status last verified
- Sep 2018
- First submitted
- 22 Sep 2016
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT02917850
- Acronym / sponsor ID
- ISOKINETIC / 2015_32
- Conditions
- Stroke, Hemiplegia, Gait
- Keywords
- stroke, gait, hip flexors, paresis, hemiplegia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isokinetic | Active comparator | Procedure: Isokinetic hip flexors strengthening, Procedure: Conventional rehabilitationPatients who benefit from the hip flexors isokinetic strengthening rehabilitation program |
| Control | Active comparator | Procedure: Conventional rehabilitationPatients who benefit from a conventional rehabilitation program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic hip flexors strengtheningIsokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w. | Procedure or surgery | Isokinetic |
| Conventional rehabilitationConventional rehabilitation 10/w during 6 weeks | Procedure or surgery | Control, Isokinetic |
Primary outcome
Max gait speed (m/s)
Time frame: 6 weeks
Gait speed will be assessed in the 10m walk test
7 secondary outcomes
Max gait speed (m/s)
Time frame: 3 and 6 months
Hip flexors strength
Time frame: 6weeks; 3 and 6 months
Gait endurance
Time frame: 6 weeks; 3 and 6 months
Gait capacities
Time frame: 6 weeks; 3 and 6 months
Balance and postural control
Time frame: 6 weeks; 3 and 6 months
Balance and postural control
Time frame: 6 weeks; 3 and 6 months
Rate of perceived exhaustion during gait
Time frame: 6 weeks; 3 and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne Allart, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic hip flexors strengthening and Conventional rehabilitation in people with Stroke and Hemiplegia, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Max gait speed (m/s) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.