NIPH Clinical Trials Search

ERTUN STUDY

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hand dysfunction
Date of first enrollment	17/09/2025
Target sample size	44
Countries of recruitment
Study type	Interventional
Intervention(s)	Participants are allocated to two groups: the "Nigirukun(R)" group, who wear the "Nigirukun(R)" glove, and the non-use group, who do not wear any device. Each group performs finger grip exercises twice a day, for one minute each session, over a four-week period.

Outcome(s)

Primary Outcome	Change in fingertip pinch strength from enrollment to 2 weeks after starting protocol treatment
Secondary Outcome	Changes in fingertip pinch stength over time Changes in lateral finger pinch strength and three-finger pinch strength over time Changes in five-finger crush strength over time Changes in forearm circumference over time Changes in Purdue Pegboard Test (manual dexterity test) over time Changes in Quick DASH over time Changes in Functional Independence Measure(FIM) over time

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients who are currently hospitalized at Nara Medical University Hospital for rehabilitation of decreased physical function 2) Patients with disability of hand and finger (physical disability certificate level 7, 4, or 3 as a guideline) 3) Patients who cannot undergo finger function rehabilitation using conventional training equipment 4) Patients aged 18 years or older 5) Patients who have given written consent (In cases where the patient is unable to sign due to hand dysfunction, etc., it is acceptable for a witness to sign and date the consent form on behalf of the patient
Exclude criteria	1) Patients with joint deformities or amputated fingers above the wrist 2) Patients diagnosed with dementia 3) Patients with fragile skin who may suffer skin damage from wearing gloves 4) Patients who cannot be assessed for hand function 5) Patients undergoing acute treatment for central nervous system disorders and neuromuscular disorders ( e.g.,Guillain-Barre syndrome,myositis) 6) Patients with severe contracture or spasticity 7) Patients with severe peripheral arterial disease, congestive heart failure or phlegmasia cerulea dolens 8) Patients with suppurative phlebitis 9) Patients whom the physician deems unsuitable for treatment