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

Wroclaw University of Health and Sport Sciences

Status: Completed

Conditions: Stroke; Subacute Stroke; Upper Extremity Dysfunction; Muscle Spasticity; Hemiparesis

Treatments: Behavioral: Therapist-assisted upper limb training; Device: Luna EMG

Study type: Interventional

Funder types: Other

Identifiers

NCT07002463

LUNA-AWF-2025-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

Robot-assisted training (Luna EMG)

Experimental group

Description:

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

Treatment:

Device: Luna EMG

Therapist-assisted training

Active Comparator group

Description:

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

Treatment:

Behavioral: Therapist-assisted upper limb training