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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stroke

Treatments: Device: sham mirror therapy; Device: mirror therapy; Device: robotic-assisted training

Study type: Interventional

Funder types: Other

Identifiers

NCT04326140

201801525B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Robotic training with mirror therapy

Experimental group

Description:

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).

Treatment:

Device: mirror therapy

Device: robotic-assisted training

Robotic-assisted training

Sham Comparator group

Description:

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.

Treatment:

Device: sham mirror therapy

Device: robotic-assisted training