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Upper Limb Botulinum Toxin Injection Combined With Self Rehabilitation (Armautotox)

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ClinicalTrials.gov Identifier: NCT02699762
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Brief Summary:
To show that the addition of a self-rehabilitation program to standard treatment, involving repeated BTI and usual physiotherapy, improves impairment and activity limitation of the paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a randomised controlled study of patients with spastic hemiparesis following stroke.

Condition or disease Intervention/treatment Phase
Self Rehabilitation Combined With BTI on Upper Limb Other: self rehabilitation of upper limb in experimental group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Other
Official Title: Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Upper Limb Function in Stroke
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: experimental group
self rehabilitation of upper limb in experimental group + BTI + usual physiotherapy
Other: self rehabilitation of upper limb in experimental group
The patients in the self-rehabilitation group will be taught the self-rehabilitation program by a physiotherapist who is not involved in the patient follow-up. They will receive a log book which will be used to evaluate compliance and tolerance to the program. They will be instructed to carry out the exercises 7 days per week for the whole duration of the study and to record which exercises they carried out and for how long, after each exercise session.

No Intervention: control group
BTI + usual physiotherapy



Primary Outcome Measures :
  1. wolf-motor functional test (WMFT) [ Time Frame: 1h ]
    functional hemiplegic's arm evaluation


Secondary Outcome Measures :
  1. modified Ashworth scale [ Time Frame: 15 minutes ]
    spasticity evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged from 18 to 75 years inclusive.
  • Women at least 24 months post menopause, or having undergone surgical sterilisation or using an effective method of contraception (oral or injected contraception or patches or a double-barrier intrauterine device).
  • Signing of the informed consent form indicating that the subject has understood the aim of the study as well as the procedures involved and that he/she accepts to participate and to comply with the demands and restrictions inherent to the study
  • Affiliation to the French social security regime or a similar regime.
  • Single stroke more than 6 months previously
  • Capable of understanding instructions and to participate in the definition of a therapeutic goal
  • Voluntary movement of the shoulder and elbow
  • Able to participate in a self-rehabilitation program
  • Having previously undergone BTI. The last injection must be at least 4 months prior to inclusion.

Exclusion Criteria:

  • Subjects who are unlikely to adhere to the study and/or poor adherence anticipated by the investigator
  • Patient with no medical insurance
  • Pregnant woman
  • Uncontrolled progressive pathology
  • Comprehension deficit (Boston Diagnostic Aphasia Examination(BDAE) <3)
  • Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study
  • Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.)
  • Surgery to the paretic limb treated in the study less than 6 months previously
  • Contra-indications to botulinum toxin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699762


Locations
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France
Raymond Poincare Hospital
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Principal Investigator: Nicolas ROCHE, MD PhD Raymond Poincare HOSPITAL

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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02699762     History of Changes
Other Study ID Numbers: 2015-A01677-42
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
self rehabilitation
stroke
botulinum toxin injection
arm functions

Additional relevant MeSH terms:
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Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs