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

The Effects of Repetitive Arm Training Combined With Functional Electrical Stimulation on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Arm Motor Recovery
• Intervention / Treatment: Device: arm training combined with FES; Other: conventional therapy

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Ferrara University Hospital
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44100
      • Physical Medicine and Rehabilitation Department Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: arm training combined with FES; 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.
Active Comparator: 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.	Other: 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. The amount of treatment will to be comparable between control and experimental groups in order to avoid possible confounding factors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	MAS: a 6-point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist	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	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	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)	FIM measures level of independence 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
Stroke Impact Scale 3.0 (SIS)	Assesses health status following stroke	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
Box and Block test	It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 min.	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 cortex excitability (single pulse and paired pulse TMS)	Single pulse TMS Single-Pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).; Paired-pulse TMS Paired-Pulse TMS will be used to study intracortical excitability.	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
Analysis of muscle activation patterns during upper extremity movements	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.	1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up
NIRS (Near Infrared Spectroscopy)	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.	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
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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Investigators: Principal Investigator: Nino Basaglia, MD, Ferrara University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Arm motor recovery; biological biomarkers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Regionale WP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No