Electrically Assisted Movement Therapy

NCT ID: NCT02563886

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EAMT, then standard care

Electrically Assisted Movement Therapy precedes usual and customary care.

Group Type: EXPERIMENTAL

Electrically Assisted Movement Therapy

Intervention Type: 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.

Usual and customary care

Intervention Type: 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.

Standard care, then EAMT

Usual and customary care precedes Electrically Assisted Movement Therapy.

Group Type: ACTIVE_COMPARATOR

Electrically Assisted Movement Therapy

Intervention Type: 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.

Usual and customary care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

EAMT; Standard care

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

Swiss Commission for Technology and Innovation

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Stefano Carda

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Carda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

José del R. Millán, Prof.

Role: STUDY_DIRECTOR

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

Locations

Service de Neuropsychologie et neuroréhabilitation - CHUV

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 28499657 (View on PubMed)

Other Identifiers

EAMT-346/15

Identifier Type: -

Identifier Source: org_study_id