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TerminatedNCT03284606NEUROTAPUpdated Jun 16, 2022

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

An interventional study of TAPING and Common rehabilitation in Hemiplegia, sponsored by University Hospital, Toulouse. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

Why this study was terminated
Recruitment default
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Hemiplegia

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    TAPING

    taping in conjunction with common rehabilitation for hemiplegic patients

    Device: TAPING · Procedure: Common rehabilitation

  • Placebo comparator
    NO TAPING

    Common rehabilitation for hemiplegic patients without taping

    Procedure: Common rehabilitation

Interventions

  • DeviceTAPING

    Taping in conjunction with common rehabilitation for hemiplegic patients

  • ProcedureCommon rehabilitation

    Common rehabilitation for hemiplegic patients

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What researchers measure

Primary outcomes

  1. voluntary muscularity

    voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny

    Time frame: Week 10

Secondary outcomes

  1. Spasticity score

    Ashworth scale modified for spasticity

    Time frame: Week 10

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Study locations

1 site
  • University Hospital Toulouse
    Toulouse, 31052, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03284606
Lead sponsor
University Hospital, Toulouse
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Sep 1, 2017
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jun 16, 2022

Study contacts

Aurélie MORIN
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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