Back to resultsRepetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
Primary Purpose
Stroke, Arm Motor Recovery
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
conventional therapy
arm training combined with FES
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Arm motor recovery, biological biomarkers
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
Sites / Locations
- Physical Medicine and Rehabilitation Department Ferrara
- Ferrara University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
arm training combined with FES
conventional therapy
Arm 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.
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.
Outcomes
Primary Outcome Measures
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Secondary Outcome Measures
Wolf Motor Function Test (WMFT) Manual
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
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
Functional Independence Measure (FIM)
FIM measures level of independence during activities of daily living.
Stroke Impact Scale 3.0 (SIS)
Assesses health status following stroke
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.
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.
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.
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.
Circulating Biomarkers
Full Information
NCT ID
NCT02267798
First Posted
January 16, 2014
Last Updated
February 2, 2017
Sponsor
University Hospital of Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT02267798
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Arm Motor Recovery
Keywords
Stroke, Rehabilitation, Arm motor recovery, biological biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm training combined with FES
Arm Type
Experimental
Arm 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.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention 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.
The amount of treatment will to be comparable between control and experimental groups in order to avoid possible confounding factors.
Intervention Type
Device
Intervention Name(s)
arm training combined with FES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Description
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Time Frame
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 Measure Information:
Title
Wolf Motor Function Test (WMFT) Manual
Time Frame
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
Title
Modified Ashworth Scale (MAS)for spasticity measure
Description
MAS: a 6-point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
Time Frame
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
Title
Motor Activity Log (MAL)measures change in arm use during activities of daily living
Description
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
Time Frame
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
Title
Functional Independence Measure (FIM)
Description
FIM measures level of independence during activities of daily living.
Time Frame
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
Title
Stroke Impact Scale 3.0 (SIS)
Description
Assesses health status following stroke
Time Frame
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
Title
Box and Block test
Description
It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 min.
Time Frame
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
Title
Motor cortex excitability (single pulse and paired pulse TMS)
Description
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.
Time Frame
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
Title
Analysis of muscle activation patterns during upper extremity movements
Description
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.
Time Frame
1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up
Title
NIRS (Near Infrared Spectroscopy)
Description
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.
Time Frame
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
Title
Circulating Biomarkers
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nino Basaglia, MD
Organizational Affiliation
Ferrara University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Medicine and Rehabilitation Department Ferrara
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31678222
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.
Results Reference
derived
Learn more about this trial
Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
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