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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267798
• Other study ID #: Regionale WP1
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: February 2, 2017
• Start date: September 2013
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Arm Motor Recovery
• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara
Italy	Physical Medicine and Rehabilitation Department Ferrara	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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