Effectiveness of Step-by-step Upper Limb Functional Exercise with Hand Brain-Machine Interface for Upper Limb Paraplegia Patients after Stroke: A Historical Control Study

UMIN ID: UMIN000055615

Registered date:25/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke (Subacute)
• Date of first enrollment: 2024/08/28
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1-2 weeks: Brain-Machine Interface 3-4 weeks: electromyogram-triggered / controlled NMES(EMG-NMES) or NMES

Outcome(s)

• Primary Outcome: Fugl-Meyer Assessment (FMA) : Before intervention, 2 weeks after intervention, 4 weeks after intervention
• Secondary Outcome: stroke impairment assessment set modified ashworth scale motor activity log functional independence measure range of motion event related desynchronization surface electromyography

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients with range of motion of the MP joint on the paralyzed side of the hand less than -10 Patients with upper limb paralysis for more than 180 days Patients who are unable to make clear decisions Patients with pacemakers or implantable cardioverter-defibrillators Patients participating in other clinical trials for upper extremity paraplegia prior to study entry Patients who have undergone botulinum therapy for spasticity of the upper limb and nerve blocks such as phenol block prior to study participation Patients who are unable to obtain an EEG due to skin conditions, cranial deformities, etc. Women who are lactating, pregnant or possibly pregnant Patients with serious diseases (e.g., complications of malignancy) Patients who are deemed inappropriate as research subjects by the investigator or physician

Related Information

• Primary Sponsor: Hokuto Social Medical Corporation Tokachi Rehabilitation Center
• Source(s) of Monetary Support: Non