NCT03284606

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

4.3 years

First QC Date

September 13, 2017

Last Update Submit

June 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • voluntary muscularity

    voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny

    Week 10

Secondary Outcomes (1)

  • Spasticity score

    Week 10

Study Arms (2)

TAPING

EXPERIMENTAL

taping in conjunction with common rehabilitation for hemiplegic patients

Device: TAPINGProcedure: Common rehabilitation

NO TAPING

PLACEBO COMPARATOR

Common rehabilitation for hemiplegic patients without taping

Procedure: Common rehabilitation

Interventions

TAPINGDEVICE

Taping in conjunction with common rehabilitation for hemiplegic patients

TAPING

Common rehabilitation for hemiplegic patients

NO TAPINGTAPING

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aurélie MORIN

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations