Clinical trial NCT02563886: Electrically Assisted Movement Therapy
Official title: Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: Swiss Commission for Technology and Innovation
First posted: 2015-09-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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);

Primary outcomes:
measure: Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
timeFrame: 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 outcomes:
measure: Wolf Motor Function Test
timeFrame: 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)
measure: Modified Ashworth scale
timeFrame: 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)
measure: European stroke scale
timeFrame: 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)
measure: Motor Activity Log
timeFrame: T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Service de Neuropsychologie et neuroréhabilitation - CHUV
state: VD
Study officials:
affiliation: Neuropsychology and Neurorehabilitation Service, Centre hospitalier universitaire vaudois (CHUV)
name: Stefano Carda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Defitech Foundation Chair in Brain-machine Interface, Swiss Federal Institute of Technology Lausanne (EPFL)
name: José del R. Millán, Prof.
role: STUDY_DIRECTOR
References:
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.