Robotic Rehabilitation in Patients With Acute Stroke

NCT ID: NCT03571529

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2020-05-31

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.

Detailed Description

Improving the rehabilitation outcome of the upper extremity in stroke patients has been an ongoing challenge in the rehabilitation field. Up to 85% of stroke survivors experience a certain degree of paresis of the upper limb at the onset and only 20% to 56% of survivors regain complete functional use of the affected upper limb despite the therapeutic interventions in first 3 months . Recovery of upper limb function is generally slower and non-complete.

To support and speed up a recovery process, there are many robotic devices currently used in the stroke units. Unlike one-on-one treatment applied by clinicans, robotic devices can provide repetitive, task oriented movements,with greater intensity, stimulating and engaging environment for user, hence alleviating the labour-intensive aspects of hands-on conventional therapy. There are a number of complex robotic devices that have been developed over the last two decades to assist upper arm training in rehabilitation.

Using EMG driven exoskeleton, commercially known as the Hand of Hope (HOH), has been shown its efficacy to improve patient's grip and pinch ability, muscle coordination and improve functional daily living tasks in patients even after 3,4,8,10 and 14 years after onset of the stroke. In addition to continuous investigation efforts needed to be spent, there has not been established any treatment protocol using EMG-driven exoskeletons. Since Stroke patients need to be focused on their own residual muscle power, clear indications for EMG-driven exoskeletons i.e., Hand of Hope, need to be established.

An investigation designed to highlight all these points will make an important contribution to the therapeutic approach using EMG-driven hand robotics for the hand rehabilitation after stroke.

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic rehabilitation

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.

Group Type: ACTIVE_COMPARATOR

EMG-driven exoskeleton hand robot

Intervention Type: 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.

Conventional physiotherapy

Intervention Type: 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

conventional physiotherapy

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.

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: 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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: collaborator

Medical Park Hospital Istanbul

OTHER

Sponsor Role: collaborator

Rehab-Robotics Company Limited

INDUSTRY

Sponsor Role: collaborator

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Dilber Karagozoglu Coskunsu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilber Karagozoglu Coskunsu, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Bahçeşehir University

Sumeyye Akcay, PT

Role: STUDY_CHAIR

Bahçeşehir University

Özden Erkan Oğul, Ass.Prof.

Role: STUDY_CHAIR

Medipol University

Kubra Yıldırım, PT

Role: STUDY_CHAIR

IAU Medical Park Florya Hospital

Yakup Krespi, Prof.

Role: STUDY_CHAIR

IAU Medical Park Florya Hospital

Haris Begovic, PhD

Role: STUDY_CHAIR

Hong Kong Polytechnic University

Necla Öztürk, Prof.

Role: STUDY_CHAIR

Maltepe University

Locations

Dilber Karagozoglu Coskunsu

Istanbul, Europe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Bahcesehir University

Identifier Type: -

Identifier Source: org_study_id