"Comparison of Therapist-Led and Robot-Assisted Arm Therapy in Subacute Stroke Rehabilitation"

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

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-03-04

Brief Summary

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This study aims to compare the outcomes of upper limb motor therapy conducted by a physiotherapist with robot-assisted therapy using the Luna EMG device in patients in the subacute phase after stroke. Additionally, the study will examine the correlation between changes in muscle tone and motor function improvement. The randomized controlled trial will be conducted at the Rehabilitation Department of the T. Marciniak Lower Silesian Specialist Hospital in Wrocław, Poland. Two groups (robot-assisted vs. conventional therapy) will perform identical sets of movements with matched repetition counts over a 6-week therapy period. Functional improvement will be assessed using Fugl-Meyer Upper Extremity Assessment (FMA-UE), Box and Block Test (B\&BT), EQ-5D-5L, and MyotonPro measurements.

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Detailed Description

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Stroke often leads to upper limb motor impairment, spasticity, and reduced independence. Robot-assisted rehabilitation, including devices like Luna EMG, may increase therapy intensity and patient motivation through feedback and movement intention detection via EMG signals.

This interventional study includes 50 participants post-stroke, randomly assigned to either robot-assisted therapy (Luna EMG) or conventional physiotherapist-led therapy. Both groups receive standard rehabilitation (75 minutes/day), with an additional 45-minute targeted upper limb training session. Sessions are conducted 5 days a week for 6 weeks.

Muscle tone will be assessed using the Modified Ashworth Scale and biomechanical parameters (stiffness, oscillation) with MyotonPro. Motor performance will be evaluated using the Fugl-Meyer Assessment (FMA-UE) and the Box and Block Test (B\&BT). Quality of life and pain perception will also be measured using the EQ-5D-5L and a numeric rating scale (NRS).

Outcome measures will be collected at baseline, after 3 weeks, after 6 weeks of therapy, and 3 weeks post-intervention to evaluate both immediate and short-term effects of the intervention. This study seeks to identify whether robotic rehabilitation offers measurable advantages over traditional methods in early post-stroke recovery.

Conditions

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Stroke Hemiparesis Muscle Spasticity Upper Extremity Dysfunction Subacute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two parallel groups: (1) robot-assisted upper limb rehabilitation using Luna EMG or (2) therapist-assisted upper limb rehabilitation. Both groups also receive the same standard rehabilitation program. Randomization was performed using simple urn-based drawing by an individual independent of the study team. An additional balancing step was applied post-assignment to ensure equal group sizes. Interventions are delivered in parallel over 6 weeks, 5 days per week.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Only the outcomes assessor is blinded. Functional and quality of life assessments (e.g., FMA-UE, Box and Blocks Test, EQ-5D-5L) are conducted by an independent physiotherapist who is not involved in treatment delivery and remains unaware of the participants' group assignments.

Due to the nature of the intervention, participants are aware of their treatment allocation (robot-assisted vs. therapist-assisted training). Similarly, physiotherapists delivering the robotic or therapist-assisted upper limb training (based on 50 EMG-triggered or assisted repetitions) are necessarily aware of group allocation. However, physiotherapists delivering the standard rehabilitation program (common to both groups) are not informed about group assignment and are considered blinded.

Study Groups

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Robot-assisted training (Luna EMG)

A robotic rehabilitation device using EMG-triggered movement assistance for upper limb recovery after stroke.

Group Type EXPERIMENTAL

Luna EMG

Intervention Type DEVICE

Participants receive additional upper limb rehabilitation using the Luna EMG robotic system. Each session includes 4 EMG-triggered exercises (shoulder flexion, external rotation, elbow extension, and forearm supination), with 50 repetitions per movement. The intervention is delivered 5 days per week for 6 weeks alongside a standard rehabilitation program.

Therapist-assisted training

A physiotherapist assists the participant in performing 4 specific upper limb movements (50 repetitions each), matching the robotic training protocol.

Group Type ACTIVE_COMPARATOR

Therapist-assisted upper limb training

Intervention Type BEHAVIORAL

Participants receive additional upper limb rehabilitation with a physiotherapist performing assisted movements equivalent to the robotic training protocol. Each session includes 4 assisted exercises (shoulder flexion, external rotation, elbow extension, and forearm supination), with 50 repetitions per movement. The intervention is delivered 5 days per week for 6 weeks alongside a standard rehabilitation program.

Interventions

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Luna EMG

Participants receive additional upper limb rehabilitation using the Luna EMG robotic system. Each session includes 4 EMG-triggered exercises (shoulder flexion, external rotation, elbow extension, and forearm supination), with 50 repetitions per movement. The intervention is delivered 5 days per week for 6 weeks alongside a standard rehabilitation program.

Intervention Type DEVICE

Therapist-assisted upper limb training

Participants receive additional upper limb rehabilitation with a physiotherapist performing assisted movements equivalent to the robotic training protocol. Each session includes 4 assisted exercises (shoulder flexion, external rotation, elbow extension, and forearm supination), with 50 repetitions per movement. The intervention is delivered 5 days per week for 6 weeks alongside a standard rehabilitation program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18-90
* First-ever ischemic or hemorrhagic stroke within 6 weeks prior to enrollment
* Stable medical condition
* Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 94
* Mini-Mental State Examination (MMSE) ≥ 23
* Signed informed consent

Exclusion Criteria

* Fixed contractures in upper limb
* MAS ≥ 3 in any upper limb muscle
* Severe vision/hearing problems
* Severe dysphagia or respiratory issues
* Myasthenia or myasthenic syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No