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

NCT07002463 | Completed

• 1 other identifier: LUNA-AWF-2025-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) motor score (0-66)

  The motor subscale of the FMA-UE was used to assess upper limb motor function. Higher scores indicate better motor performance. The motor score was predefined as the primary outcome prior to data analysis.

  Baseline, Week 3, Week 6, and 3 weeks after therapy completion

Secondary Outcomes (10)

• Change in total Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score (0-126)

  Baseline, Week 3, Week 6, and 3 weeks after therapy completion

• Box and Blocks Test (B&BT)

  Baseline, Week 3, Week 6, and 3 weeks after therapy completion

• EQ-5D-5L

  Baseline, Week 3, Week 6, and 3 weeks after therapy completion

• Muscle Tone - Modified Ashworth Scale (MAS)

  Baseline, Week 3, Week 6, and 3 weeks after therapy completion

• Muscle Oscillation Frequency Measured by MyotonPRO

  Baseline, Week 3, Week 6, and 3 weeks after therapy completion

Study Arms (2)

Robot-assisted training (Luna EMG)

EXPERIMENTAL

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

Device: Luna EMG

Therapist-assisted training

ACTIVE COMPARATOR

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

Behavioral: Therapist-assisted upper limb training

Interventions

Luna EMG 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.

Robot-assisted training (Luna EMG)

Therapist-assisted upper limb training 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.

Therapist-assisted training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

Study Sites (1)

Lower Silesian Specialist Hospital T. Marciniak - Emergency Medicine Center

Wroclaw, 54-049, Poland

Location

MeSH Terms

Conditions

Stroke; Paresis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Denis Moskiewicz, M.Sc.

  Department of Physiotherapy, Wroclaw University of Health and Sport Sciences, 51-612 Wrocław, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc., Assistant Lecturer, Dept. of Neurological and Pediatric Physiotherapy

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 3, 2025
• Study Start: April 3, 2023
• Primary Completion: February 12, 2024
• Study Completion: March 4, 2024
• Last Updated: April 23, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)