Clinical research for efficacy and safety of hand-finger rehabilitation robot SMOVE for the patients with upper limb paresis after recovery stage stroke patients.

JRCT ID: jRCTs032220269

Registered date:12/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with upper limb paresis after recovery stage stroke patients.
• Date of first enrollment: 03/02/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

[SMOVE group]
With the forearm resting on the fixing jig, perform finger movement function training using SMOVE for 20 minutes (1 unit).
[Standard rehabilitation treatment group]
20 minutes (1 unit) of hand movement function training with the assistance of a rehabilitation therapist according to exercise recall.

Outcome(s)

• Primary Outcome: The amount of change in the total amount of Active Range Of Motion (AROM) between the fingers of each joint of all the affected fingers other than thumb from the pre-intervention evaluation to the 6-week post-intervention evaluation.

Secondary Outcome

1. Changes in other endpoints from pre-intervention evaluation to 6 weeks after intervention.
2. The amount of change in the total finger AROM of each joint of all the affected fingers other than thumb and the amount of change in other outcomes from the pre-intervention evaluation to the 4-week post-intervention.
Other Outcomes
1) Sum of finger AROM of each joint for each affected finger
2) Finger AROM of each joint on the affected side
3) AROM on the affected elbow joint and affected wrist joint
4) Affected side Fugl-Meyer Assessment (FMA): Upper limbs
5) Affected side Action Research Arm Test (ARAT)
6) Brunnstrom stage (BRS) on the affected upper limb
7) Affected finger BRS
8) Modified Ashworth Scale (MAS): Affected wrist joint, elbow joint, finger joint
9) Grip strength on the affected side
10) Pinch force on the affected side
11) Motor activity Log (MAL) -14

Key inclusion & exclusion criteria

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

Include criteria

1) Patients at the age of 20 to 85 at the time of obtaining consent.
2) Patients who have a first-onset stroke (CIS: clinically isolated syndrome).
3) Patients with hemiplegic upper limb and the type of stroke is cerebral infarction or cerebral hemorrhage (not targeted for subarachnoid hemorrhage).
4) Patients within 15-83 days after stroke onset at the time consent is obtained.
5) Patients within 22-90 days after stroke onset at the start of the study intervention.
6) Patients hospitalized for post-stroke rehabilitation unit or equivalent ward.
7) Patients with hand/finger Brunnstrom stage II to III.
8) JCS (Japan Coma Scale): 0

Exclude criteria

[at the time of 1st registration]
1) Patients with hemiplegic upper limb following subarachnoid hemorrhage.
2) Patients with any upper extremity paresis caused by previous stroke.
3) Patients with having upper limb paresis caused not by cerebral stroke.
4) Patients with severe spasticity upper than MAS 3 (Modified Ashworth Scale).
5) Patients with forced grasping or apraxia.
6) Patients who are treated with type A botulinus toxin or ITB (intrathecal baclofen) therapy.
7) Patients with mental illness(Excluding patients whose primary disease is stable on medication and other.) .
8) Patients with cognitive dysfunction less than MMSE 23 (Mini Mental State Examination).
9) Patients with significantly impaired vision or hard of hearing.
10) An untenable state that patients being treated with rehabilitation therapy in convalescent stage rehabilitation beds.
11) Patients who cannot identify myopotential and cannot start the extension mode operation of SMOVE.
12) Patients whose skin condition is not suitable for electrodes placement, or device putting on their hands.
13) Patients receiving continuous oxygen administration, antiarrhythmic drug / antihypertensive drug / antihypertensive drug by intravenous drip.
14) Patients with severe hepatic / renal /cardiac / pulmonary failure.
15) Patients with a cardiac pacemaker or implantable cardioverter-defibrillator.
16) Patients with malignant tumor not completely cured.
[at the time of 2nd registration]
1) Patients who are found to newly violate the exclusion criteria 1) to 16) at the time of 1st registration.
2) Patients who have recovered 4 or more points of FMA-UE (Fugl-Meyer Assessment) between the time of 1st registration and 2nd.

Related Information

• Primary Sponsor: Mukae Nobutaka
• Source(s) of Monetary Support: megwel Co.,Ltd.