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Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers (NEUROTAP)

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ClinicalTrials.gov Identifier: NCT03284606
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
Groupement Interrégional de Recherche Clinique et d'Innovation
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

A majority of people undergoing rehabilitation following a stroke have a deficit of the dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance with the recommendations of learned societies is not sufficient to compensate for this deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its action on muscle, joint, circulatory and pain functions.

The use of taping would increase the duration of stimulation of the muscles of the dorsiflexors of the foot which would facilitate the motor recovery.

Data from the literature do not support the conclusion that taping is effective, but no studies evaluating the efficacy of this technique in the foot-lift deficiency of the hemiplegic patient have been found.

The investigators hypothesize that the use of taping in conjunction with common rehabilitation for hemiplegic patients following a stroke improves the stimulation of the muscles of the dorsiflexors of the foot with a positive impact on the walking.


Condition or disease Intervention/treatment Phase
Hemiplegia Device: TAPING Procedure: Common rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: TAPING
taping in conjunction with common rehabilitation for hemiplegic patients
Device: TAPING
Taping in conjunction with common rehabilitation for hemiplegic patients

Procedure: Common rehabilitation
Common rehabilitation for hemiplegic patients

Placebo Comparator: NO TAPING
Common rehabilitation for hemiplegic patients without taping
Procedure: Common rehabilitation
Common rehabilitation for hemiplegic patients




Primary Outcome Measures :
  1. voluntary muscularity [ Time Frame: Week 10 ]
    voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny


Secondary Outcome Measures :
  1. Spasticity score [ Time Frame: Week 10 ]
    Ashworth scale modified for spasticity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a stroke occurring in a period ranging from 15 days to a month before inclusion and presenting left or right hemiplegia.
  • Voluntary motricity of the dorsal flexors of the foot greater than or equal to 1 on the scale of Held and Pierrot Deseilligny
  • Quadriceps voluntary motor skill greater than or equal to 2 on the scale of Held and Pierrot Deseilligny
  • Informed consent of the patient.

Exclusion Criteria:

  • - Evolutive neurological disease leading to cognitive impairment (Alzheimer's, Parkinson's, Multiple sclerosis ...)
  • Pre-stroke neurological sequelae
  • Achilles tendon elongation or tendinous transfer surgery.
  • Spasticity of the sural triceps greater than 2 on the modified Ashworth scale
  • Injection of botulinum toxin
  • Patients under guardianship, curatorships or under safeguard of justice.
  • Allergy to glue, skin lesions located on the zone of laying of the bands
  • Complex Regional Pain Symptom of the Ankle

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): NCT03284606


Contacts
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Contact: Aurélie MORIN 0561322804 morin.a@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Recruiting
Toulouse, France, 31052
Contact: Aurélie Morin, physiotherapist         
Sponsors and Collaborators
University Hospital, Toulouse
Groupement Interrégional de Recherche Clinique et d'Innovation
Investigators
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Principal Investigator: Aurélie MORIN Univesity Hospital Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03284606     History of Changes
Other Study ID Numbers: RC31/15/7839
2016-A01552-49 ( Registry Identifier: French ANSM )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms