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
About this trial
This is an interventional treatment trial for Hemiplegia
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
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
NCT ID
NCT03284606
First Posted
September 13, 2017
Last Updated
June 13, 2022
Sponsor
University Hospital, Toulouse
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation
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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