There is Constraint-Induced Movement Therapy (CIMT), an approach that inhibits  the use of unaffected side and intensively trains the functional tasks of the upper limb. However, problems such as the burden of the patient caused by intense training of CIMT and excessive restraint, an increased risk of falls, and the difficulty of temporarily living independently were raised. In order to minimize this problem, modified Constraint-Induced Movement Therapy (mCIMT) was designed to reduce the restraint time of the upper limb and the training time of the upper limb to report a positive effect on the recovery of function in stroke patients. In addition, mCIMT promotes changes in cortical properties in both the contralateral and ipsilateral hemispheres of stroke lesions. Recently, many interventions that combine tDCS that directly induces such changes with rehabilitation intervention have been conducted. However, most of the previous studies have investigated the effects of unilateral or bilateral tDCS or combined intervention effects such as CIMT or robot therapy, which have limitations in clinical application in terms of patient burden or cost as an intervention used with tDCS. Therefore, since there are few studies related to the combined intervention of mCIMT and tDCS, it is considered necessary to verify this.

Treatment

The experimental group and control group will undergo dual-tDCS for 20 minutes prior to receiving mCIMT. It is conducted for 20 minutes at a time, 5 times a week, for 4 weeks in total. The equipment used for the Dual-tDCS in this study is TheBrainDriver v2.1 tDCS (TheBrainDriver v2.1, TheBrainDriver, USA), which uses an electrode with a diameter of 5 cm. For the electrode attachment site, the anode stimulus is attached to the primary motor cortex on the damaged side, and the cathode stimulus is attached to the primary motor cortex on the non-damaged side, and the stimulation protocol applies a constant current of 1 mA intensity for 20 minutes. The placebo control group is applied to the same location for 20 minutes without applying current.
mCIMT conducted in the experimental group and the control group will proceed for 30 minutes immediately after the tDCS is performed. While awake for a total of 4 weeks and 5 days a week, the use of gloves will limit the movement of the wrists and hands of the upper limbs., except for washing and eating and receiving physical and occupational therapy in daily life. The repetitive intensive training program for the upper extremity consists of eight tasks: placing in a rubber ball basket, carrying a plastic bottle, carrying a pegboard, flipping a card, picking up beans, stacking cones, turning a bookshelf, and putting a coin.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The experimental group will undergo dual-tDCS for 20 minutes prior to receiving mCIMT. It is conducted for 20 minutes at a time, 5 times a week, for 4 weeks in total. The equipment used for the Dual-tDCS in this study is TheBrainDriver v2.1 tDCS (TheBrainDriver v2.1, TheBrainDriver, USA), which uses an electrode with a diameter of 5 cm. For the electrode attachment site, the anode stimulus is attached to the primary motor cortex on the damaged side, and the cathode stimulus is attached to the primary motor cortex on the non-damaged side, and the stimulation protocol applies a constant current of 1 mA intensity for 20 minutes. 
mCIMT conducted in the experimental group will proceed for 30 minutes immediately after the tDCS is performed. While awake for a total of 4 weeks and 5 days a week, the use of gloves will limit the movement of the wrists and hands of the upper limbs., except for washing and eating and receiving physical and occupational therapy in daily life. The repetitive intensive training program for the upper extremity consists of eight tasks: placing in a rubber ball basket, carrying a plastic bottle, carrying a pegboard, flipping a card, picking up beans, stacking cones, turning a bookshelf, and putting a coin.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The control group will undergo dual-tDCS for 20 minutes prior to receiving mCIMT. It is conducted for 20 minutes at a time, 5 times a week, for 4 weeks in total. The equipment used for the Dual-tDCS in this study is TheBrainDriver v2.1 tDCS (TheBrainDriver v2.1, TheBrainDriver, USA), which uses an electrode with a diameter of 5 cm. For the electrode attachment site, the anode stimulus is attached to the primary motor cortex on the damaged side, and the cathode stimulus is attached to the primary motor cortex on the non-damaged side. The placebo control group is applied to the same location for 20 minutes without applying current.
mCIMT conducted in the the control group will proceed for 30 minutes immediately after the sham tDCS is performed. While awake for a total of 4 weeks and 5 days a week, the use of gloves will limit the movement of the wrists and hands of the upper limbs., except for washing and eating and receiving physical and occupational therapy in daily life. The repetitive intensive training program for the upper extremity consists of eight tasks: placing in a rubber ball basket, carrying a plastic bottle, carrying a pegboard, flipping a card, picking up beans, stacking cones, turning a bookshelf, and putting a coin.

Gender

Age

Description

Patients who agreed to participate in the study
Adults aged 20 to 90 and those with chronic stroke (>180 days after onset)
Patients without cognitive impairment with MMSE-K 24 or higher

Patients who  Infarct or hemorrhage in both hemispheres or brainstem areas
Patients who  spontaneous stiffness of the joints between the metacarpophalangeal joints and interphalangeal joints is 10° or less and 20° or less, respectively.
Patients who serious damage in balancing or walking
Patients with uncontrolled health conditions or serious terminal illness other than stroke
Patients with severe stiffness in the shoulders, elbows, wrists, or fingers

Motor Activity Log(MAL)

72 hours before the start of intervention, 72 hours after intervention

accelerometer

72 hours before the start of intervention, 72 hours after intervention

Fugle-Meyer Assessment(FMA)

72 hours before the start of intervention, 72 hours after intervention

General characteristics of subjects

Prior to initial evaluation

There were no significant differences in general characteristics and baseline of study subjects between the experimental and the control group. The experimental group and the control group showed significant improvement in FMA and AOU of MAL, Use of unaffected side, and Use of affected side, excluding QOM of MAL. As a result of comparison between groups through ANCOVA, the experimental group showed statistically significant improvement only in the AOU of MAL (p<.05, d=.93) and the Use of unaffected side (p<.05, d=1.07) than the control group. On the other hand, there was no statistical difference in the QOM of MAL and Use of affected side of FMA. However, In effect size Cohen's d, all evaluations including FMA(d=.58), QOM of MAL(d=.28) and use of affected side(d=55) showed a difference in effect size more than small effect.