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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02917850
Other study ID # 2015_32
Secondary ID 2016-A00366-45
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date July 2018

Study information

Verified date September 2018
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Isokinetic hip flexors strengthening
Isokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w.
Conventional rehabilitation
Conventional rehabilitation 10/w during 6 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary Max gait speed (m/s) Gait speed will be assessed in the 10m walk test 6 weeks
Secondary Max gait speed (m/s) Gait speed will be assessed in the 10m walk test 3 and 6 months
Secondary Hip flexors strength Hip flexors strength will be evaluated using an isokinetic dynamometer (concentric, 30°/s) and motor testing (medical research council) 6weeks; 3 and 6 months
Secondary Gait endurance Gait endurance will be assessed using the 6MWT 6 weeks; 3 and 6 months
Secondary Gait capacities Functional ambulation categories (FAC) 6 weeks; 3 and 6 months
Secondary Balance and postural control Postural Assessment for Stroke Scale (PASS) 6 weeks; 3 and 6 months
Secondary Balance and postural control Timed-up and go test 6 weeks; 3 and 6 months
Secondary Rate of perceived exhaustion during gait Borg scale 6 weeks; 3 and 6 months
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