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

NCT07002463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Wroclaw University of Health and Sport Sciences

    lead OTHER

Principal Investigators

  • Denis Moskiewicz, M.Sc. · Department of Physiotherapy, Wroclaw University of Health and Sport Sciences, 51-612 Wrocław, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2024-02-12
Completion
2024-03-04

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002463 on ClinicalTrials.gov