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Electrically Assisted Movement Therapy (EAMT)

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ClinicalTrials.gov Identifier: NCT02563886
Recruitment Status : Unknown
Verified February 2016 by Stefano Carda, Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
Swiss Commission for Technology and Innovation
Information provided by (Responsible Party):
Stefano Carda, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Other: Electrically Assisted Movement Therapy Other: Usual and customary care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: EAMT, then standard care
Electrically Assisted Movement Therapy precedes usual and customary care.
Other: Electrically Assisted Movement Therapy
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.
Other Name: EAMT

Other: Usual and customary care
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.
Other Name: Standard care

Active Comparator: Standard care, then EAMT
Usual and customary care precedes Electrically Assisted Movement Therapy.
Other: Electrically Assisted Movement Therapy
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.
Other Name: EAMT

Other: Usual and customary care
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.
Other Name: Standard care




Primary Outcome Measures :
  1. Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), [ 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) ]
    A quantitative measure of motor impairment.


Secondary Outcome Measures :
  1. Wolf Motor Function Test [ 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) ]
    Quality and time of task performance

  2. Modified Ashworth scale [ 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) ]
    A quantitative measure of hand and arm spasticity

  3. European stroke scale [ 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) ]
    Overall functional status

  4. Motor Activity Log [ Time Frame: T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start ]
    Semi-structured interview to assess arm function.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563886


Locations
Switzerland
Service de Neuropsychologie et neuroréhabilitation - CHUV
Lausanne, VD, Switzerland, 1011
Sponsors and Collaborators
Swiss Federal Institute of Technology
Centre Hospitalier Universitaire Vaudois
Swiss Commission for Technology and Innovation
Investigators
Principal Investigator: Stefano Carda, MD, PhD Neuropsychology and Neurorehabilitation Service, Centre hospitalier universitaire vaudois (CHUV)
Study Director: José del R. Millán, Prof. Defitech Foundation Chair in Brain-machine Interface, Swiss Federal Institute of Technology Lausanne (EPFL)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefano Carda, MD, PhD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02563886     History of Changes
Other Study ID Numbers: EAMT-346/15
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases