HAL-SJ Pilot study

JRCT ID: jRCTs052180010

Registered date:28/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acute stroke with upper extremity motor deficit
• Date of first enrollment: 08/01/2019
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Motor training of affected upper extremity using
Hal-SJ for 20 minutes + conventional motor training for 20 minutes
Conventional motor training of affected upper extremity for 40 minutes
Each group are subjected to perform 3 weeks, 5 times a week

Outcome(s)

• Primary Outcome: Fugl-Meyer Assessment score of upper extremity

Secondary Outcome

Efficacy measurements;
(1)FMA proximal UE (total score of shoulder, elbow, forearm and wrist)
(2)Brunnstrom stage, upper extremity and finger
(3)Modified Ashworth Scale, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension
(4)Action Research Arm Test
(5)Functional Independent Measure
(6)Motor activity Log
Safety measurements;
(1)Occurrence rate of any adverse event or failure during three weeks after starting intervention

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

-Acute stroke patients (except for subarachnoid hemmorrhage and transient ischemic attack) with unilateral upper extremity motor deficits
-Brunnstrom stage of upper extremity of deficit side between II and V
-Patients who can start intervention between 10 and 16 days after stroke onset, and who can be followed-up throughout study period

Exclude criteria

-Any upper extremity paresis caused by previous stroke
-Diagnosed as stroke due to cerebral arteriovenous malformation, dural arteriovenous fistula, moyamoya disease, sinus thrombosis or cavernous malformation
-Severe contracture of affected upper extremity

Related Information

• Primary Sponsor: Miyamoto Susumu
• Source(s) of Monetary Support: AMED