Armautotox
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
Sponsor study identifier
interventional
35
1 country
1
Study Start
March 2016
Actual (reported)Primary Completion
February 2018
Actual (reported)Study Completion
March 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2016
Actual (reported)March 1, 2016
Actual (reported)March 4, 2016
Actual (reported)February 2018
Actual (reported)March 2018
Actual (reported)wolf-motor functional test (WMFT)
functional hemiplegic's arm evaluation
1h
modified Ashworth scale
15 minutes
self rehabilitation of upper limb in experimental group + BTI + usual physiotherapy
BTI + usual physiotherapy
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Raymond Poincare Hospital
Garches, 92380, France
Maulet T, Pouplin S, Bensmail D, Zory R, Roche N, Bonnyaud C. Self-rehabilitation combined with botulinum toxin to improve arm function in people with chronic stroke. A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101450. doi: 10.1016/j.rehab.2020.10.004. Epub 2020 Dec 17.
Nicolas ROCHE, MD PhD
Raymond Poincare HOSPITAL
35 participants (actual enrollment reported by the registry).
First Submitted
March 1, 2016
First Posted
March 4, 2016
Study Start
March 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 2018
Actual (reported)Study Completion
March 2018
Actual (reported)Last Updated
April 13, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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