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

Not Applicable

Completed

• Conditions: Stroke; Arm Motor Recovery
• Interventions: Device: arm training combined with FES; Other: conventional therapy

• Registration Number: NCT02267798
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-20
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm training combined with FES	arm training combined with FES	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.
conventional therapy	conventional therapy	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.

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)	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 of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary Outcome Measures

Name	Time	Method
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	MAS: a 6-point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
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	Motor Activity Log (MAL): assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities
Box and Block test	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	It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 min.
Analysis of muscle activation patterns during upper extremity movements	1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up	A measure of the coordination of muscular activity across muscles of the upper limbs will be derived from recordings performed during a series of upper extremity motor tasks.
NIRS (Near Infrared Spectroscopy)	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	For the NIRS it will use an 32-channel NIRS imaging equipment which consist of 16 pairs of emitting and detecting optical fibers attached to a custom-made head cap placed on primary motor cortex.; NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.
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	FIM measures level of independence during activities of daily living.
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	Assesses health status following stroke
Motor cortex excitability (single pulse and paired pulse TMS)	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	1. Single pulse TMS Single-Pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).; 2. Paired-pulse TMS Paired-Pulse TMS will be used to study intracortical excitability.
Circulating Biomarkers	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

Trial Locations

Locations (2)

Physical Medicine and Rehabilitation Department Ferrara; 🇮🇹 Ferrara, Emilia Romagna, Italy

Ferrara University Hospital; 🇮🇹 Ferrara, Italy