Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

University Hospital of Ferrara

Status: Completed

Conditions: Stroke; Arm Motor Recovery

Treatments: Other: conventional therapy; Device: arm training combined with FES

Study type: Interventional

Funder types: Other

Identifiers

NCT02267798

Regionale WP1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

arm training combined with FES

Experimental group

Description:

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.

Treatment:

Device: arm training combined with FES

conventional therapy

Active Comparator group

Description:

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.

Treatment:

Other: conventional therapy