Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke

NCT ID: NCT04326140

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-12-31

Brief Summary

This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke.

Detailed Description

Approximately 70% to 80 % of stroke patients suffered from upper limb (UE) hemiparesis which limited their daily function and quality of life, as well as required considerable demands of long-term medical care. Robot-assisted training and mirror priming has been advocated as part of contemporary approaches. The robotic-assisted therapy mainly emphasized on the proximal part of UE, such as shoulder and elbow movement. While mirror priming strategy has been increasingly employed in the UE training, one question has been raised: the affected UE of stroke patients cannot complete the same movement as the sounded limb synchronously. This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke. This project will further explore the possible neuro-muscular mechanism underlying this combined mirror priming with robotic training. This project attempts to compare the cortical activation and neuromuscular control of patients with stroke and age-matched healthy adults in terms of electroencephalography (EEG) and muscle tone measurement. The findings of this study may lay an evidence-based foundation for bridging basic science and clinical application.

Conditions

Stroke

Study Design

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

Study Groups

Robotic training with mirror therapy

Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).

Group Type: EXPERIMENTAL

mirror therapy

Intervention Type: DEVICE

The affected side wears the machine, assists by the machine, and performs the same action with the good hand. According to the posture condition, selects two suitable actions in the three actions (all fingers open, all fingers close, all fingers open and close). The action is 10 minutes each.

robotic-assisted training

Intervention Type: DEVICE

The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.

Robotic-assisted training

The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.

Group Type: SHAM_COMPARATOR

robotic-assisted training

Intervention Type: DEVICE

The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.

sham mirror therapy

Intervention Type: DEVICE

The mirror was masked. The intervention was the same as the mirror therapy.

Interventions

mirror therapy

The affected side wears the machine, assists by the machine, and performs the same action with the good hand. According to the posture condition, selects two suitable actions in the three actions (all fingers open, all fingers close, all fingers open and close). The action is 10 minutes each.

Intervention Type: DEVICE

robotic-assisted training

The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.

Intervention Type: DEVICE

sham mirror therapy

The mirror was masked. The intervention was the same as the mirror therapy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Stroke more than 3 months.
• Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
• The myoelectric signal can be detected to activate the instrument
• Unilateral paresis (FMA score<60)
• No serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
• Can provide informed consent

Exclusion Criteria

• Other neurological disease
• Complete sense of body defect
• Inability to understand instructions
• current participation in any other research
• Botulinum Toxin injection within 3 months

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ching-yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

#886-3-2118800 ext. 5761

Facility Contacts

Ching-Yi Wu, ScD

Role: primary

cywu@mail.cgu.edu.tw

886-3-2118800 ext. 5761

Other Identifiers

201801525B0

Identifier Type: -

Identifier Source: org_study_id