Experimental Design
stroke, limb motor dysfunction, knee flexion, Upper extremity movements, Hand movements, Lower extremity movements
STROKE
This clinical trial is planned to be carried out in 2 clinical trial institutions at the same time and is divided into an experimental group and a control group. Patients in the experimental group received exercise training guided by the remote rehabilitation training system, routine clinical physical therapy (PT) training, and routine drug treatment. By contrast, patients in the control group received routine clinical occupational therapy (OT) training, routine clinical PT training, and routine drug treatment (see According to the inclusion criteria, this study selects all patients who conform to the entire trial process, that is, those who conform to the trial protocol, have good compliance, and can complete the corresponding tasks for analysis. The patients are randomly allocated to the experimental and control group in a 1:1 ratio, and the main efficacy index (Fugl-Meyer score of patients) was used as the basis for case estimation, with the sample size calculated according to the following formula [
According to class II medical devices recognized by the industry, when the probability of type I error α is set to 1-sided .025, Considering whether the patients were exposed to PT/OT training and reducing the associated effects, this clinical trial protocol used a randomized grouping approach in which all patients who met the inclusion criteria were randomly assigned to either the test or control group according to randomization rules. The randomization method and steps were as follows: (1) Patients were randomized according to the stratified block randomization method. First, the random seed was set, then the block length was determined and stratified according to the center. SAS version 9.4 (SAS Institute) was used to generate a random grouping table of 120 patients receiving the trial (experimental group or control group). Each center was assigned consecutive random numbers that connect with each other. The patients were randomly assigned to either the experimental group or the control group according to the order in which the cases were enrolled and the randomization table.As the training methods were different for the 2 groups, an open randomized trial was used. After randomizing patients to 1 of the 2 groups, neither the investigator nor the patients knew the grouping when baseline scoring was performed. At the beginning of the training, the randomized envelope for rehabilitation training corresponding to each randomization number was opened to know the corresponding training method. Thus, the investigator and patients only became aware of the grouping and scoring results after starting training. The statistical analysts, however, before unblinding, were not aware of the patients’ grouping.The flowchart of this clinical trial is shown in Clinical trial flowchart.According to related studies [Upper extremity movements: (1) Bobath handshake training, (2) Bobath flexion and extension, (3) Bobath external anterior flexion and extension, (4) Bobath pre- and postrotation, (5) breast expansion exercise, (6) shoulder joint internal and external rotation, (7) shoulder touch training, and (8) elbow joint flexion and touch. Hand movements: (1) flexion-pressure rotation forward and backward, (2) wrist flexion and extension, (3) elbow flexion and wrist compression training, (4) finger-to-finger training, and (5) ball gripping training. Lower extremity movements: (1) squat training, (2) knee flexion and extension, and (3) knee internal and external rotation.The experimental group adopted the training method of the remote rehabilitation training system and routine clinical PT training, whereas the control group used routine clinical rehabilitation training methods for limb motor dysfunction (ie, routine clinical OT training and routine clinical PT training).For the inpatients in the experimental and control groups, the specific diagnosis and treatment methods were based on the condition and the test content, and the corresponding training and rehabilitation exercise methods that could be completed independently were selected in the rehabilitation hall. In addition, they performed system-guided training or routine clinical OT training 2 times a day (each session lasted 30 minutes) and conventional PT training 2 times a day (each session lasted 30 minutes). They trained no less than 10 times a week, for a total of no less than 30 times, for a total of 3 weeks.In this study, the simplified Fugl-Meyer Motor Function Assessment scale was used for evaluation. The scale has good reliability and validity, Cronbach reliability coefficient >.80, and intraclass correlation coefficient >0.70 [The scale consists of 50 items, including 33 for the upper extremities and 17 for the lower extremities, with each item rated on a scale of 0 (unable to complete the specified movement), 1 (able to partially complete), or 2 (can fully complete). The total score is 100 points. The higher the score, the better the motor function of the patient. At baseline and after 3 weeks of training, the patients were assessed by the rehabilitation physician according to the Fugl-Meyer Assessment (FMA) scale and the related results were recorded, respectively.To study the rehabilitation training under the real nonphysician involvement scenario, the rehabilitation physician or therapist was next to the patient during the whole rehabilitation training process, only to ensure the patient’s safety. In addition, the rehabilitation data from the experimental group were uploaded to the rehabilitation website so that the physician could view the training data and update the exercise prescription as necessary from the office. The actual training of patients with stroke is shown in Practical application of the 2 training methods: (A) patients in the control group using conventional occupational therapy training; (B) patients in the experimental group using a remote rehabilitation training system.