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

NCT02917850 | Withdrawn

• 2 other identifiers: 2015_322016-A00366-45
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Hemiplegia; Gait

Keywords

stroke; gait; hip flexors; paresis; hemiplegia

Outcome Measures

Primary Outcomes (1)

• Max gait speed (m/s)

  Gait speed will be assessed in the 10m walk test

  6 weeks

Secondary Outcomes (7)

• Max gait speed (m/s)

  3 and 6 months

• Hip flexors strength

  6weeks; 3 and 6 months

• Gait endurance

  6 weeks; 3 and 6 months

• Gait capacities

  6 weeks; 3 and 6 months

• Balance and postural control

  6 weeks; 3 and 6 months

Study Arms (2)

Isokinetic

ACTIVE COMPARATOR

Patients who benefit from the hip flexors isokinetic strengthening rehabilitation program

Procedure: Isokinetic hip flexors strengthening; Procedure: Conventional rehabilitation

Control

ACTIVE COMPARATOR

Patients who benefit from a conventional rehabilitation program

Procedure: Conventional rehabilitation

Interventions

Isokinetic hip flexors strengthening PROCEDURE

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

Isokinetic

Conventional rehabilitation PROCEDURE

Conventional rehabilitation 10/w during 6 weeks

Control; Isokinetic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Etienne Allart, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 28, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09