Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study (MECASPRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323943
Recruitment Status : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
University Hospital of Saint-Etienne
Information provided by (Responsible Party):
Thuasne

Brief Summary:

Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. As a consequence, walking performances are reduced and energy cost of walking is deteriorated. This may increase performance fatigability, as the locomotion will be realized at a higher percentage of the subjects' capacities. In order to overcome these issues, different treatments are proposed. One of the most conventional solutions are the use of ankle foot orthosis (AFO) and it is the most commonly prescribed device used to compensate for "foot drop". There is a very large choice of AFO on the market which can be proposed to patients with foot drop.

The aim of this study is thus to assess the mechanical effects of using a manufactured carbon AFO in by comparison to a custom-made thermo-plastic AFO on walking capacity (distance and energy cost), fatigue and "foot drop" control throughout the gait phase in patients with hemiparetic stroke.


Condition or disease Intervention/treatment Phase
Hemiparesis;Poststroke/CVA Gait, Hemiplegic Device: Ankle Foot orthosis (AFO) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, cross-over, open labelled, monocentric, controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
Estimated Study Start Date : June 2, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Foot Health

Arm Intervention/treatment
Experimental: Carbon-AFO (C-AFO)
Manufactured carbon ankle foot orthosis (C-AFO) Sprystep (Thuasne) will be provided to patients. A familiarization with C-AFO will be performed before doing the tests.
Device: Ankle Foot orthosis (AFO)

The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order).

Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4.

During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order :

  • 5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured
  • 6MWT where energy cost will be measured
  • 5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed
Other Name: Sprystep (Thuasne)

Active Comparator: Custom-made thermo-plastic orthosis (CM-AFO)
Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests.
Device: Ankle Foot orthosis (AFO)

The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order).

Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4.

During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order :

  • 5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured
  • 6MWT where energy cost will be measured
  • 5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed
Other Name: Sprystep (Thuasne)

No Intervention: Without orthosis (NO)
No orthosis - patient will wear only their shoes



Primary Outcome Measures :
  1. Distance walked during the 6 Minute Walk Test (6MWT) [ Time Frame: Day : 14 ]

    Patient will performed three experimental session (14 days between each session) during wich the primary outcome will be assessed : one session while walking with C-AFO, one session while walking with CM-AFO, and one session while walking without AFO (randomized order).

    6 Minute Walk Test is a beneficial tool to evaluate walking endurance in patients with poststroke hemiparesis



Secondary Outcome Measures :
  1. Energy cost [ Time Frame: Day : 14 ]
    Energy cost will be assessed by oxygen consumption recorded during the 6MWT in the 3 conditions (C-AFO, CM-AFO, NO)

  2. Muscular activity [ Time Frame: Day: 14 ]
    Muscular activity will be assessed by electromyography (EMG) on different muscles (anterior tibial, gastroc medial, femoral). Muscular activity will be assessed before and after 6MWT during 5*15m sessions

  3. Angle [ Time Frame: Day : 14 ]
    Angle (°) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

  4. Perceived fatigue [ Time Frame: Day : 14 ]
    Perceived fatigue will be assessed by the Rated Perceived Exertion (RPE) scale before and after 6MWT

  5. Power [ Time Frame: Day : 14 ]
    Power (watt) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

  6. Momentum [ Time Frame: Day : 14 ]
    Momemtum (J rad−1) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

  7. Satisfaction related to the device [ Time Frame: Day : 42 ]
    A satisfaction survey will be asked in order to assess the positioning of AFO, comfort, esthetic and global satisfaction of devices



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemiparetic patients, walking with CM-AFO
  • Diagnosis of a first stroke since at least 6 months with medical conditions of stroke known, treatment proposed, cardio-vascular and neurological state stabilized
  • Foot drop observed during the swing phase of gait, requiring the use of a custom-made plastic orthosis that has been used for at least 3 months and used for less than 2 years
  • Muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale
  • Sufficient motor ability and endurance to ambulate at least 15 m independently without AFO
  • Patient who signed a consent

Exclusion Criteria:

  • Patient without any scanner to confirm CVA
  • Cerebellar syndrome associated
  • Multiple stroke - other neurological or psychiatric conditions, epilepsy
  • Patient with malignant disease or kidney disease or unstable or decompensated diabetes
  • Cardiovascular/respiratory disorders which can influence performance of patients during the tests
  • Drug / alcohol dependence
  • Pregnant women
  • Patient under justice protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323943


Contacts
Layout table for location contacts
Contact: Paul Calmels, MD, PhD +33 4 77 12 03 83 paul.calmels@chu-st-etienne.fr
Contact: Diana Rimaud, PhD +33 6 76 97 86 74 diana.rimaud@chu-st-etienne.fr

Locations
Layout table for location information
France
Chu Saint Etienne
Saint-Étienne, France, 42055
Contact: Paul Mr Calmels, MD, PhD    +33 4 77 12 03 83    paul.calmels@chu-st-etienne.fr   
Sub-Investigator: Leonard FEASSON, MD, PhD         
Sub-Investigator: Guillaume MILLET, PhD         
Principal Investigator: Paul CALMELS, MD, PhD         
Sponsors and Collaborators
Thuasne
University Hospital of Saint-Etienne
Investigators
Layout table for investigator information
Principal Investigator: Paul Calmels, MD,PhD CHU Saint Etienne, Bellevue

Layout table for additonal information
Responsible Party: Thuasne
ClinicalTrials.gov Identifier: NCT04323943    
Other Study ID Numbers: EC28
ANSM ( Other Identifier: 2019-A02957-50 )
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Paresis
Gait Disorders, Neurologic
Fatigue
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases