Clinical research of Intelligent Stroke Rehabilitation System for upper-limb Impairment after stroke

INTERVENTION: ARM1: Intelligent Stroke Rehabilitation System is a device which assists rehabilitation doctors and therapies to do functional assessment for the hemiplegic upper limb of stroke patients, and also provides equipment for rehab exercises. It consists of a doctor station and a patient station. The doctor station is operated by the therapist in hospital and includes system software and data memory. Through the system software, therapists can perform the following tasks on computer: storage and query of patient information, evaluation of patient upper limb function, movement selection, and exercise parameter settings. The therapist stores the training program into the data memory for patients. The patient station is used by patients in the hospital treatment room or at home and includes: data acquisition, an infrared reflective garment, and infrared reflective glove. During rehabilitation training, the patient puts the infrared reflective garment and the infrared reflective glove on the affected upper limb, standing or sitting on the direction of the data acquisition unit at a certain distance. The data memory is inserted into the data acquisition unit which is connected with a TV to show the training system interface. Body positioning and screen touching training are based on system prompts. After finishing the training, the patient turns off the data acquisition unit, and takes off the infrared reflective garment and infrared reflective glove. At regular follow‐up visits, training records recorded on the data memory are examined by the therapist by computer to determine whether re‐evaluation of upper limb function is needed. If re‐evaluation is needed, movement selections and exercise parameters will be set up; if it is not needed, the system software can automatically update the training program according to the training performance of the patient at the previous stage, and therapists can adjust corresponding training exercise parameters according to the actual situation of the patients. Then, the training program is stored in the data memory for the next rehabilitation training sessions. Thirty‐two movements achieving goals make up the core of the sports training of the system. Additionally, it includes 4 warm‐up and relaxation exercises. We designed these upper limb motions (excluding hand) according to the Chinese Stroke Full Guideline. The rehab system structure and algorithm supports four sets: self‐assisted, active feedback, table‐assisted and active motion. The rehab system guides patients to do exercises which cover 3 joints: shoulder, elbow and wrist. There were two sets involved in the 8 week exercise training. Exercise Set: Two sets of exercises were used in the 8 weeks exercise training 9 Self‐assisted exercises: the movement of the affected upper extremity is driven by the healthy upper extremity (Bobath method) 2 shoulder joint active exercises. In the first 4 weeks, 9 self‐assisted exercises and 4 warm‐up and relaxation exercises were used. In the second 4 weeks, 2 shoulder joint active exercises, 9 self‐assisted exercises, and 4 warm‐up and relaxation exercises were used. Exercise plan: Therapist chose 6‐8 movements from the above exercise set every 2 weeks according to the subject’s condition. The therapist could determine range of motion and the number of repetitions for the chosen exercise. Exercise schedule: There were a total of 8 weeks of system therapy on the hemiplegic upper extremity (excluding hand), with 9 sessions per week, 20 minutes per session, for a total of 72 sessions. ARM2: CONDITION: Cerebral Infarction SECONDARY OUTCOME: The safety of the system as assessed through the observation on the incidence of Adverse Events(AEs) like cardiovascular events, movement injuries, and pain, etc The role of therapist during the system guided training: The therapist guided patients to understand and use the rehab system at the beginning of training, for example, how to complete calibration and how to follow guidance from the system. The therapists did not have any physical contact with the patients during the exercising process. Hemiplegic upper extremities (excluding hands) from treatment and control groups received neurodevelopmental treatment (NDT) based on conventional physical therapy. This consisted of one‐on‐one treatment provided by therapists focusing on exercise therapy including: active, passive, and assisted joint mobility, voluntary movement of shoulder, elbow, wrist and fingers in all directions, forearm rotation, relaxation exercises of upper limbs, limb positioning and maintaining activities, muscle stretch training, coordination training, task oriented training, and Activities of Daily Living training. Details of hemiplegic hand and lower extremity treatment of the treatment group and the control group were not specified for the trial and they were decided by therapists based on subject circumstances. There were a total of 8 weeks of conventional physical therapy on the hemiplegic limb: for the first 4 weeks, 5 minutes/session for the upper extremity, and 15 minutes/session for the hand and lower extremity; and for the second 4 weeks, 10 minutes/session for the PRIMARY OUTCOME: upper limb motor function as assessed using a mean proximal subscore (shoulder/elbow/wrist subsections) of Modified Fugl‐Meyer Motor Score of the upper extremity (FM‐prox, 0 to 46). ; The occurrence or changes of AEs can be concluded on the basis of the patient’s spontaneous report, physical examination, special lab tests (X‐ray, CT, MRI, etc.), or the original data of AEs. Each AE will be evaluated from the perspective of duration, intensity, severity and the causal relationship with studied intervention. ; frequency of upper limb daily performance as assessed using a mean Amount Scale score of Motor Activity Log (MAL AS score, 0 to 5) ; quality of upper limb daily performance as assessed using a mean How Well Scale score of Motor Activity Log (MAL HW score, 0 to 5) upper limb motor function as assessed using a mean median time of Graded Wolf Motor Function Test (GWMFT median time,0 to 120s) upper limb motor function as assessed using a mean proximal subscore(shoulder/elbow/forearm/wrist subsections) of Motor Status Score (MSS‐prox, 0 to 46) upper limb motor function as assessed using a mean total score (shoulder/elbow/wrist/hand subsections) of Modified Fugl‐Meyer Motor Score of the upper extremity (FM sum, 0 to 66). upper limb motor function as assessed using a mean total score of Graded Wolf Motor Function Test (GWMFT total score, 0 to 7) upper limb muscle tension as assessed using a mean total score of modified Ashworth scale(the tone of the shoulder adductors, the flexors of the elbow and wrist) (AS sum, 0 to 15) INCLUSION CRITERIA: within 3 months of the first time onset of cerebral infarction >= 18 years old brain unilateral lesions focused in the middle cerebral artery, confirmed by CT or MRI obvious unilateral hemiplegia: severe motor dysfunction in upper extremity, proximal Fugl‐Meyer subscore (FM‐prox, 0 to 46) 6–13, lower extremity Brunnstrom classification <= 4 With normal language understanding and cognitive function, and capable of signing informed consent and coordinating with the treating program.