Electrically Assisted Movement Therapy (EAMT)
Primary Purpose
Cerebrovascular Accident
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Electrically Assisted Movement Therapy
Usual and customary care
Sponsored by

About this trial
This is an interventional treatment trial for Cerebrovascular Accident
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of one, first ever stroke (both ischemic or hemorrhagic) verified by brain imaging (MRI or CT);
- Chronic impairment after stroke (minimum 6 months);
- No contraindications to MRI;
- No contraindications to electrical stimulation;
Exclusion Criteria:
- Unstable recovery stage (difference between two examinations > 1 FMA-UE point);
- Mild impairment of the upper extremity (FMA-UE >= 21);
- Excessive spasticity of the affected arm (modified Ashworth Scale > 2);
Sites / Locations
- Service de Neuropsychologie et neuroréhabilitation - CHUV
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EAMT, then standard care
Standard care, then EAMT
Arm Description
Electrically Assisted Movement Therapy precedes usual and customary care.
Usual and customary care precedes Electrically Assisted Movement Therapy.
Outcomes
Primary Outcome Measures
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
A quantitative measure of motor impairment.
Secondary Outcome Measures
Wolf Motor Function Test
Quality and time of task performance
Modified Ashworth scale
A quantitative measure of hand and arm spasticity
European stroke scale
Overall functional status
Motor Activity Log
Semi-structured interview to assess arm function.
Full Information
NCT ID
NCT02563886
First Posted
September 22, 2015
Last Updated
February 23, 2016
Sponsor
Swiss Federal Institute of Technology
Collaborators
Centre Hospitalier Universitaire Vaudois, Swiss Commission for Technology and Innovation
1. Study Identification
Unique Protocol Identification Number
NCT02563886
Brief Title
Electrically Assisted Movement Therapy
Acronym
EAMT
Official Title
Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Centre Hospitalier Universitaire Vaudois, Swiss Commission for Technology and Innovation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether intensive, focused training of the affected upper extremity after stroke results in long-term functional gains in moderately-to-severely paralyzed patients, more than 6 months after their vascular accident. During the course of therapy, user's attempts to move and complete exercises are assisted by neuromuscular electrical stimulation.
Detailed Description
This pilot study quantifies functional gains induced by the Electrically Assisted Movement Therapy (EAMT), an extension of Constraint-Induced Movement Therapy to moderately-to-severely paralyzed patients in their stable plateau phase of recovery. During EAMT, patients can assist affected upper limb movements through functional electrical stimulation. Initially, patients are divided in two groups. One of the groups receives EAMT, the other receives the best possible physical and occupational therapy. Therapy consists in 40 sessions of 45 minutes twice per day over five weeks, including a one-week therapy break. After 20 sessions, group allocation is crossed-over, and patients don't receive any therapy for one week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EAMT, then standard care
Arm Type
Experimental
Arm Description
Electrically Assisted Movement Therapy precedes usual and customary care.
Arm Title
Standard care, then EAMT
Arm Type
Active Comparator
Arm Description
Usual and customary care precedes Electrically Assisted Movement Therapy.
Intervention Type
Other
Intervention Name(s)
Electrically Assisted Movement Therapy
Other Intervention Name(s)
EAMT
Intervention Description
Electrically Assisted Movement Therapy (EAMT) is an extension of conventional Constraint-Induced Movement Therapy (CIMT) for moderately-to-severely paralyzed patients. During EAMT, patients use a movement controller with the healthy hand, controlling movements generated through neuromuscular electrical stimulation of the paralyzed arm and hand. During each session three types of exercises can be performed: mobilization, games, and training for activities of daily living, all three involving proper shaping of exercise difficulty at therapist discretion. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks.
Intervention Type
Other
Intervention Name(s)
Usual and customary care
Other Intervention Name(s)
Standard care
Intervention Description
Usual and customary care ranges from no treatment to varying amounts of orthotics, home-based and clinic-based occupational therapy, or physiotherapy, but always excludes CIMT and EAMT. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks, whenever possible, to match EAMT amount of therapy.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
Description
A quantitative measure of motor impairment.
Time Frame
T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment)
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Quality and time of task performance
Time Frame
T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment)
Title
Modified Ashworth scale
Description
A quantitative measure of hand and arm spasticity
Time Frame
T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment)
Title
European stroke scale
Description
Overall functional status
Time Frame
T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment)
Title
Motor Activity Log
Description
Semi-structured interview to assess arm function.
Time Frame
T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of one, first ever stroke (both ischemic or hemorrhagic) verified by brain imaging (MRI or CT);
Chronic impairment after stroke (minimum 6 months);
No contraindications to MRI;
No contraindications to electrical stimulation;
Exclusion Criteria:
Unstable recovery stage (difference between two examinations > 1 FMA-UE point);
Mild impairment of the upper extremity (FMA-UE >= 21);
Excessive spasticity of the affected arm (modified Ashworth Scale > 2);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Carda, MD, PhD
Organizational Affiliation
Neuropsychology and Neurorehabilitation Service, Centre hospitalier universitaire vaudois (CHUV)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José del R. Millán, Prof.
Organizational Affiliation
Defitech Foundation Chair in Brain-machine Interface, Swiss Federal Institute of Technology Lausanne (EPFL)
Official's Role
Study Director
Facility Information:
Facility Name
Service de Neuropsychologie et neuroréhabilitation - CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28499657
Citation
Carda S, Biasiucci A, Maesani A, Ionta S, Moncharmont J, Clarke S, Murray MM, Millan JDR. Electrically Assisted Movement Therapy in Chronic Stroke Patients With Severe Upper Limb Paresis: A Pilot, Single-Blind, Randomized Crossover Study. Arch Phys Med Rehabil. 2017 Aug;98(8):1628-1635.e2. doi: 10.1016/j.apmr.2017.02.020. Epub 2017 May 9.
Results Reference
derived
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