Clinical trial NCT07002463: "Comparison of Therapist-Led and Robot-Assisted Arm Therapy in Subacute Stroke Rehabilitation"
Official title: "Comparison of Outcomes of Physiotherapist- and Robot-Assisted Upper Limb Therapy and Their Association With Muscle Tone and Motor Function in Subacute Stroke Patients"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Muscle Spasticity
Upper Extremity Dysfunction
Subacute Stroke
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Secondary outcomes:
measure: Box and Blocks Test (B&BT)
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: EQ-5D-5L
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Muscle Tone - Modified Ashworth Scale (MAS)
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Muscle Oscillation Frequency Measured by MyotonPRO
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Muscle Stiffness Measured by MyotonPRO
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Muscle Elasticity Measured by MyotonPRO
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Muscle Relaxation Time Measured by MyotonPRO
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Muscle Creep Measured by MyotonPRO
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
measure: Pain Intensity (NRS 0-10)
timeFrame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion (Rest and activity)
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Lower Silesian Specialist Hospital T. Marciniak - Emergency Medicine Center
Study officials:
affiliation: Department of Physiotherapy, Wroclaw University of Health and Sport Sciences, 51-612 Wrocław, Poland
name: Denis Moskiewicz, M.Sc.
role: STUDY_CHAIR
References: