Robotic Rehabilitation in Patients With Acute Stroke

NCT03571529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-14

No results posted yet for this study

Summary

The advantage of the EMG-driven exoskeletons is that patient's own muscle power known as Residual Muscle Power is used to move the extremity while many other robotic devices work and drive impaired limb based on machine directed force. However, it is not clear which group of patients are suitable for EMG driven exoskeletons use and there has not been any established treatment protocol.

The aims of the study are 1- to investigate the effectiveness of the EMG-driven exoskeleton for hand rehabilitation in patients with acute stroke. 2- to understand which group of the patients may give the best response to the EMG-driven technology and how should be the treatment protocol designed.

Conditions

  • Acute Stroke

Interventions

DEVICE

EMG-driven exoskeleton hand robot

Primary Outcome Measurement: 1\. Fugl-Meyer Upper Extremity Assessment Secondary Outcome Measurements: 1. Action Research Arm Test 2. Motor Activity Log 3. Data from force and EMG measurement records of HOH robot 4. Grip strength (with hand dynamometer) 5. Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers 6. Manuel muscle testing for wrist and finger muscles. 7. Modify Asworth sclale At the beginning of each robotic treatment session, superficial EMG recording will be taken at relax position ( without muscle contraction) and then during maximal voluntary isometric contraction (MVC) after the patient's hand is placed in the exoskeleton. For both, EMG recording is performed for 7 seconds and Root Mean Square (RMS) is calculated from this record.

OTHER

Conventional physiotherapy

Primary Outcome Measurement: 1\. Fugl-Meyer Upper Extremity Assessment Secondary Outcome Measurements: 1. Action Research Arm Test 2. Motor Activity Log 3. Data from force and EMG measurement records of HOH robot 4. Grip strength (with hand dynamometer) 5. Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers 6. Manuel muscle testing for wrist and finger muscles. 7. Modify Asworth sclale

Sponsors & Collaborators

  • Medipol University

    collaborator OTHER
  • Medical Park Hospital Istanbul

    collaborator OTHER
  • Rehab-Robotics Company Limited

    collaborator INDUSTRY
  • Bahçeşehir University

    lead OTHER

Principal Investigators

  • Dilber Karagozoglu Coskunsu, Ass.Prof. · Bahçeşehir University

  • Sumeyye Akcay, PT · Bahçeşehir University

  • Özden Erkan Oğul, Ass.Prof. · Medipol University

  • Kubra Yıldırım, PT · IAU Medical Park Florya Hospital

  • Yakup Krespi, Prof. · IAU Medical Park Florya Hospital

  • Haris Begovic, PhD · Hong Kong Polytechnic University

  • Necla Öztürk, Prof. · Maltepe University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2020-03-31
Completion
2020-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT03571529 on ClinicalTrials.gov