Electrically Assisted Movement Therapy

NCT02563886 | Unknown

• 1 other identifier: EAMT-346/15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),

  A quantitative measure of motor impairment.

  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 (4)

• Wolf Motor Function Test

  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)

• Modified Ashworth scale

  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)

• European stroke scale

  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)

• Motor Activity Log

  T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start

Study Arms (2)

EAMT, then standard care

EXPERIMENTAL

Electrically Assisted Movement Therapy precedes usual and customary care.

Other: Electrically Assisted Movement Therapy; Other: Usual and customary care

Standard care, then EAMT

ACTIVE COMPARATOR

Usual and customary care precedes Electrically Assisted Movement Therapy.

Other: Electrically Assisted Movement Therapy; Other: Usual and customary care

Interventions

Electrically Assisted Movement Therapy OTHER

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.

Also known as: EAMT

EAMT, then standard care; Standard care, then EAMT

Usual and customary care OTHER

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.

Also known as: Standard care

EAMT, then standard care; Standard care, then EAMT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Centre Hospitalier Universitaire Vaudois: collaborator
• Swiss Commission for Technology and Innovation: collaborator

Study Sites (1)

Service de Neuropsychologie et neuroréhabilitation - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28499657 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stefano Carda, MD, PhD

  Neuropsychology and Neurorehabilitation Service, Centre hospitalier universitaire vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

• José del R. Millán, Prof.

  Defitech Foundation Chair in Brain-machine Interface, Swiss Federal Institute of Technology Lausanne (EPFL)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)