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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-13

Study Completion Date

2027-07-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Stroke Hemiplegia and Hemiparesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The intervention group will be compared to a matched historical cohort, that will be added to in parallel during recruitment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

High dosage, high intensity motor rehabilitation

Intervention Type BEHAVIORAL

Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.

Matched group from an ongoing project with identical criteria.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High dosage, high intensity motor rehabilitation

Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No