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

Clinical research of Intelligent Stroke Rehabilitation System for upper-limb Impairment after stroke in cerebral infarction patients with severe upper-limb impairment

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000132741
Enrollment
26
Registered
2013-02-04
Start date
2010-08-16
Completion date
2011-08-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To testify the efficacy, safety and treatment time point of the Intelligent Stroke Rehabilitation System in managing severe upper-limb impairment after stroke by comparing the efficacy of using the Intelligent Stroke Rehab system and self-exercise with guiding pictures. Our study hypothesis is that efficacy of the rehab system would surpass that of control group above 10%~20%, which receives self-exercise with guiding pictures.

Interventions

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 quer

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. 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. 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: 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 upper extremity, and 10 minutes/session for the hand and lower extremity. There were 5 sessions per week, for a total of 40 sessions.

Sponsors

Philips Research Asia, Shanghai(PRAS)
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Patients with the following manifestations were excluded: heart, liver, kidney and lung failure, uncontrolled arrhythmia, malignant tumor, musculoskeletal disease significantly affecting the motor function and other neurological disorders, restrictions of upper limb movement, impaired vision, impaired hearing, laterality agnosia and apraxia, impaired cognitive function (Folstein Mini-Mental State Examination, MMSE <22 points), incapable of maintaining sitting homeostasis, serious upper extremity sensory disturbances, severe upper limb joint pain, significant shoulder subluxation, serious upper limb muscle spasms (Modified Ashworth scale = 3), upper limb skin bedsores, and severe hand edema

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026