Clinical trial NCT02267798: Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
Official title: The Effects of Repetitive Arm Training Combined With Functional Electrical Stimulation on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Arm Motor Recovery
Keywords: Stroke
Rehabilitation
Arm motor recovery
biological biomarkers
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Primary endpoint: Fugl-Meyer Upper Extremity (FM-UE) Secondary endpoints: Box and Block Test (BBT), Modified Ashworth Scale (MAS); motor cortex excitability (TMS); Electromyography analysis of muscle activation patterns during upper extremity movements; measurements of cerebral perfusion (NIRS); circulating biomarkers (see Figure 3 and Table 1). Overall assessments will be performed pre-, mid-, post-treatment and at 6-months follow-up.

Eligibility criteria: Inclusion criteria:

* males and females, age 18 to 79 years
* diagnosis of first, single unilateral ischemic stroke verified by brain imaging \< 8 weeks
* upper limb motor function defined by an FM-UE score \> 11 and \<55

Exclusion criteria:

* medical conditions likely to interfere with the ability to safely complete the study protocol
* impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
* severe upper-limb pain, referred as \> 7 at Visual Analog Scale (VAS)
* history of seizures or epilepsy

Primary outcomes:
measure: Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
timeFrame: 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.
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT) Manual
timeFrame: 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
measure: Modified Ashworth Scale (MAS)for spasticity measure
timeFrame: 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
measure: Motor Activity Log (MAL)measures change in arm use during activities of daily living
timeFrame: 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
measure: Functional Independence Measure (FIM)
timeFrame: 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
measure: Stroke Impact Scale 3.0 (SIS)
timeFrame: 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
measure: Box and Block test
timeFrame: 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
measure: Motor cortex excitability (single pulse and paired pulse TMS)
timeFrame: 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
measure: Analysis of muscle activation patterns during upper extremity movements
timeFrame: 1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up
measure: NIRS (Near Infrared Spectroscopy)
timeFrame: 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
measure: Circulating Biomarkers
timeFrame: 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
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Physical Medicine and Rehabilitation Department Ferrara
state: Emilia Romagna
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara University Hospital
name: Nino Basaglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.