The Effects of Repetitive Arm Training Combined With Functional Electrical Stimulation on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
Sponsor study identifier
interventional
64
1 country
2
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2016
Actual (reported)Study Completion
November 2016
Actual (reported)Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The relationship between intensity of rehabilitation and clinical outcomes, recently emphasized, has generated a great interest for technological high-intensity interventions. However, their effects compared to traditional interventions as well the involved biological mechanisms remain uncertain. The present Strategic Program aims to predict the treatment efficacy in specific rehabilitation profiles, to improve the use of "targeted" therapies and the individual management of patients affected by stroke and to transfer these findings into rehabilitative strategies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2014
Actual (reported)October 20, 2014
Actual (reported)November 2016
Actual (reported)November 2016
Actual (reported)Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up.
Wolf Motor Function Test (WMFT) Manual
1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up
Modified Ashworth Scale (MAS)for spasticity measure
1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up
Motor Activity Log (MAL)measures change in arm use during activities of daily living
1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up
Functional Independence Measure (FIM)
1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up
Stroke Impact Scale 3.0 (SIS)
1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up
Arm training protocol Training sessions will last for 60 minutes and will focus on repetitive tasks that incorporate multidirectional reaching actions. In this robot-assisted therapy a robot manipulator applies forces to the paretic arm during goal-directed movements. Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists of a battery powered programmable stimulator and a forearm-wrist-hand orthosis containing 5 electrodes positioned to provide reliable activation of muscles. The intensity of stimulation will be set to a level that provided comfortable and consistent activation of the extensor and flexor muscles to achieve whole hand opening and functional grasping.
The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence, Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques based on neuro-developmental treatment.
The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence. Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques. The amount of treatment will to be comparable between control and experimental groups in order to avoid possible confounding factors.
Physical Medicine and Rehabilitation Department Ferrara
Ferrara, Emilia-Romagna, 44100, Italy
Ferrara University Hospital
Ferrara, Ferrara, 44124, Italy
Straudi S, Baroni A, Mele S, Craighero L, Manfredini F, Lamberti N, Maietti E, Basaglia N. Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):309-316. doi: 10.1016/j.apmr.2019.09.016. Epub 2019 Nov 1.
Nino Basaglia, MD
Ferrara University Hospital
64 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2014
First Posted
October 20, 2014
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Arm training protocol Training sessions will last for 60 minutes. The Reo Therapy System is robot-assisted therapy; during the session the subject's affected hand is placed on or strapped onto a robotic arm and the subject is instructed to either actively reach predefined reach points, or to be guided while the robotic arm leads the arm towards these reach points. Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists is a stimulator containing 5 electrodes positioned to provide reliable activation of the following muscles: extensor digitatum communis and extensor pollices brevis, flexor pollices longus, flexor digitatum superficialis, and thenar muscles.
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Primary Completion
November 2016
Actual (reported)Study Completion
November 2016
Actual (reported)Last Updated
February 3, 2017
Record last verified: 2017-02
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