Robotic Rehabilitation in Patients With Acute Stroke

NCT03571529 | Completed

• 1 other identifier: Bahcesehir University
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EMG driven exoskeleton; hand rehabilitation; hand function; upper extremity outcome

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity Assessment:

  Fugl-Meyer assessment was first used in 1975 to assess post-stroke physical performance. 33-item upper extremity subscale of the Fugl-Meyer scale evaluates movements, coordination/speed and pain in the shoulder, elbow, forearm. The highest score for the upper extremity is 66.

  Change from pre-interventional Fugl-Meyer Upper Extremity score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.

Secondary Outcomes (6)

• Action Research Arm Test (ARAT)

  Change from pre-interventional ARAT score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.

• Motor Activity Log

  Change from pre-interventional Motor Activity Log score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.

• Manuel muscle testing

  Change from pre-interventional Manuel muscle testing scores at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.

• Range of motion measurement (ROM)

  Change from pre-interventional ROMs at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.

• Force and EMG measurement with the testing device

  Change from pre-interventional force and EMG measurement with the testing device at the end of the 5th session, 10th session and 15 session intervention that will be performed at the last session of each week at a total of 3 weeks.

Study Arms (2)

Robotic rehabilitation

ACTIVE COMPARATOR

Active Comparator: Robotic rehabilitation Protocol with EMG-driven hand exoskeleton (Hand of Hope): Warm-up: 10 min passive mode 2 min resting Training: According to residual muscle power: * 10 min active-assistive, 2 min resting, 10 min Active-assistive or * 5 min active, 2 min resting, 15 min active assistive or * 10 min active, 2 min resting, 10 min active and * 10 min window cleaning game Robotic rehabilitation will be applied 5 times a week; Totally 15 sessions (3 weeks). Conventional physiotherapy also will be performed to the robotic rehabilitation group.

Device: EMG-driven exoskeleton hand robot; Other: Conventional physiotherapy

conventional physiotherapy

ACTIVE COMPARATOR

Conventional Physiotherapy will be performed to the both group 5 sessions a week and totally 15 sessions (3 weeks). Conventional physiotherapy will include neurophysiological approaches. Each session will last around 1,5 hours.

Other: Conventional physiotherapy

Interventions

EMG-driven exoskeleton hand robot DEVICE

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.

Robotic rehabilitation

Conventional physiotherapy OTHER

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

Robotic rehabilitation; conventional physiotherapy

Eligibility Criteria

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

You may qualify if:

• Having ischemic stroke history within last 4 weeks
• Being at the age 18 and older than 18
• Providing a sitting balance during the robot training (maximum 1 hour with preparation time)
• Understanding and performing simple commands
• Full range of motion in MCP, PIP and DIP
• MAS \< 3 for finger flexors and extensors
• Participants who agree to participate in the study

You may not qualify if:

• Recurrent stroke
• Other neurologic or orthopedic problems that may affect to upper extremity functions
• Hemispatial neglect (will be diagnosed by Line bisection test and The star cancellation test)
• Refused treatment, non-cooperation
• MAS ≥ 3 (MAS will be measured every week during the treatment period)

Sponsors & Collaborators

• Bahçeşehir University: lead
• Medipol University: collaborator
• Medical Park Hospital Istanbul: collaborator
• Rehab-Robotics Company Limited: collaborator

Study Sites (1)

Dilber Karagozoglu Coskunsu

Istanbul, Europe, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dilber Karagozoglu Coskunsu, Ass.Prof.

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

• Sumeyye Akcay, PT

  Bahçeşehir University

  STUDY CHAIR

• Özden Erkan Oğul, Ass.Prof.

  Medipol University

  STUDY CHAIR

• Kubra Yıldırım, PT

  IAU Medical Park Florya Hospital

  STUDY CHAIR

• Yakup Krespi, Prof.

  IAU Medical Park Florya Hospital

  STUDY CHAIR

• Haris Begovic, PhD

  The Hong Kong Polytechnic University

  STUDY CHAIR

• Necla Öztürk, Prof.

  Maltepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: June 27, 2018
• Study Start: April 6, 2018
• Primary Completion: March 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

TU (1)