The Efficacy of Additional Motor Training Dosage During the Early Stages Post Stroke on the Upper Extremity Recovery (EFODIN)

Adi Negev-Nahalat Eran

Status: Enrolling

Conditions: Stroke; Hemiplegia and Hemiparesis

Treatments: Behavioral: High dosage, high intensity motor rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07056049

NGV-24-0006

Details and patient eligibility

About

Intervention abstract

Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life.

Despite the decline in stroke-related mortality over the past decades, the outcome of rehabilitation programs does not improve, and is predictable regardless of the program used. Still, several human and animal studies show that high capacity of training in the early stages post stroke improve motor recovery. This notion is far from being well established.

Aim: Studying the effect of high-dosage, high-intensity training program in the subacute period on upper extremity motor recovery.

Population: Stroke survivors. Study duration: 6 months. Study protocol: Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. They will be monitored pre and post training, and 6 months post-stroke. Outcome measures will include clinical, kinematic and adherence measures (see complete list in the protocol).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI
• First-ever stroke or previous stroke with no upper extremity weakness
• 1 week ≤ Time after stroke onset ≤ 6 weeks
• Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement
• Ability to provide inform consent

Exclusion criteria

• A painful shoulder limiting an active forward reach
• Severe spasticity or non-neural loss of range of motion
• Cognitive or communication impairments as determined by the clinical team Unstable medical conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

This group will be provided with additional rehab time during the sub actue phase.

Experimental group

Description:

Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. The program will be tailored to their impairment level, and will be added to the usual treatment given during hospitalization.

Treatment:

Behavioral: High dosage, high intensity motor rehabilitation

Matched group from an ongoing project with identical criteria.

No Intervention group

Description:

This group is comprised of patients with similar characteristics and the intervention group will be compared to this group.