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

Primary Purpose

Hemiplegia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TAPING
Common rehabilitation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAPING

NO TAPING

Arm Description

taping in conjunction with common rehabilitation for hemiplegic patients

Common rehabilitation for hemiplegic patients without taping

Outcomes

Primary Outcome Measures

voluntary muscularity
voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny

Secondary Outcome Measures

Spasticity score
Ashworth scale modified for spasticity

Full Information

First Posted
September 13, 2017
Last Updated
June 13, 2022
Sponsor
University Hospital, Toulouse
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT03284606
Brief Title
Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers
Acronym
NEUROTAP
Official Title
A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment default
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAPING
Arm Type
Experimental
Arm Description
taping in conjunction with common rehabilitation for hemiplegic patients
Arm Title
NO TAPING
Arm Type
Placebo Comparator
Arm Description
Common rehabilitation for hemiplegic patients without taping
Intervention Type
Device
Intervention Name(s)
TAPING
Intervention Description
Taping in conjunction with common rehabilitation for hemiplegic patients
Intervention Type
Procedure
Intervention Name(s)
Common rehabilitation
Intervention Description
Common rehabilitation for hemiplegic patients
Primary Outcome Measure Information:
Title
voluntary muscularity
Description
voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Spasticity score
Description
Ashworth scale modified for spasticity
Time Frame
Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie MORIN
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31052
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers

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