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

A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers

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.

Study Overview

• Status: Terminated
• Conditions: Hemiplegia
• Intervention / Treatment: Device: TAPING; Procedure: Common rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31052
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
voluntary muscularity	voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny	Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity score	Ashworth scale modified for spasticity	Week 10

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation
• Investigators: Principal Investigator: Aurélie MORIN, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: RC31/15/7839; 2016-A01552-49 (Registry Identifier: French ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No