Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000132741
Ethics application status
Approved
Date submitted
31/01/2013
Date registered
4/02/2013
Date last updated
22/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical research of Intelligent Stroke Rehabilitation System for upper-limb Impairment after stroke
Scientific title
Clinical research of Intelligent Stroke Rehabilitation System for upper-limb Impairment after stroke in cerebral infarction patients with severe upper-limb impairment
Secondary ID [1] 281856 0
Nil
Universal Trial Number (UTN)
U1111-1138-9640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Infarction 288218 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288584 288584 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286415 0
Treatment: Devices
Intervention code [2] 286416 0
Rehabilitation
Comparator / control treatment
The control group received self-exercises by picture guidance. The picture exercise is a control devised to approximate the novel intervention and is according to the Chinese Stroke Full Guideline.
Exercise Set: 9 self-assisted exercises, 2 shoulder joint active exercises, 3 relaxation exercises and a muscle stretch exercise. In the first 4 weeks, 9 self-assisted exercises, 3 relaxation exercises and a muscle stretch exercise were used. In the second 4 weeks, all 15 exercises in the pictures were used.
Exercise plan: The therapist chose 6-8 movements from the above exercise set every 2 weeks according to the subject’s condition and asked them to self-exercise guided by the pictures.
The role of the therapist during self-exercise: The therapist explained the key points of movement in the pictures followed by verbal guidance and demonstration. Therapists did not have any physical contact with the patients during the self-exercise.
Exercise schedule: There were a total of 8 weeks of self-exercise guided by pictures on the hemiplegic upper limb (excluding hand), with 9 sessions per week, 20 minutes per session, for a total of 72 sessions.
Control group
Active

Outcomes
Primary outcome [1] 288746 0
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).
Timepoint [1] 288746 0
at 4th week and 8th week after intervention
Secondary outcome [1] 300892 0
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).
Timepoint [1] 300892 0
at 4th week and 8th week after intervention
Secondary outcome [2] 300893 0
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)
Timepoint [2] 300893 0
at 4th week and 8th week after intervention
Secondary outcome [3] 300895 0
upper limb motor function as assessed using a mean total score of Graded Wolf Motor Function Test (GWMFT total score, 0 to 7)
Timepoint [3] 300895 0
at 4th week and 8th week after intervention
Secondary outcome [4] 300896 0
upper limb motor function as assessed using a mean median time of Graded Wolf Motor Function Test (GWMFT median time,0 to 120s)
Timepoint [4] 300896 0
at 4th week and 8th week after intervention
Secondary outcome [5] 300897 0
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)
Timepoint [5] 300897 0
at 4th week and 8th week after intervention
Secondary outcome [6] 300903 0
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 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.
Timepoint [6] 300903 0
at baseline, 4th week and 8th week after intervention
Secondary outcome [7] 300924 0
frequency of upper limb daily performance as assessed using a mean Amount Scale score of Motor Activity Log (MAL AS score, 0 to 5)
Timepoint [7] 300924 0
at 4th week and 8th week after intervention
Secondary outcome [8] 300925 0
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)
Timepoint [8] 300925 0
at 4th week and 8th week after intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2010
Actual
16/08/2010
Date of last participant enrolment
Anticipated
Actual
31/08/2011
Date of last data collection
Anticipated
Actual
31/08/2011
Sample size
Target
26
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 4829 0
China
State/province [1] 4829 0
Shanghai

Funding & Sponsors
Funding source category [1] 286650 0
Commercial sector/Industry
Name [1] 286650 0
Philips Research Asia, Shanghai(PRAS)
Country [1] 286650 0
China
Primary sponsor type
Commercial sector/Industry
Name
Philips Research Asia, Shanghai(PRAS)
Address
Building 1. No.10, Lane.888, Tian Lin Road, Min Hang District, Shanghai, P.R.China,200233
Country
China
Secondary sponsor category [1] 285432 0
Hospital
Name [1] 285432 0
Huashan Hospital, Fudan University
Address [1] 285432 0
No.12,Wulumuqi Zhong Road, Jing An District, Shanghai, P.R.China,200040
Country [1] 285432 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288725 0
Huashan Hospital, Fudan University,Institutional Review Board
Ethics committee address [1] 288725 0
No.12,Wulumuqi Zhong Road, Jing An District, Shanghai, P.R.China,200040
Ethics committee country [1] 288725 0
China
Date submitted for ethics approval [1] 288725 0
10/05/2010
Approval date [1] 288725 0
19/05/2010
Ethics approval number [1] 288725 0
(2010)Grant No.115

Summary
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.
Trial website
Trial related presentations / publications
No trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37406 0
Prof Yi Wu
Address 37406 0
Dept. of Rehabilitation Medicine, Huashan Hospital, Fudan University
No.12,Wulumuqi Zhong Road, Jing An District, Shanghai, P.R.China,200040
Country 37406 0
China
Phone 37406 0
+86 021 52887820
Fax 37406 0
Email 37406 0
1323866881@qq.com
Contact person for public queries
Name 37407 0
Wenke Fan
Address 37407 0
Room 501, No. 24, Lane.1349,Nan Ma Tou Road, Pu Dong New District, Shanghai, P.R.China,200125
Country 37407 0
China
Phone 37407 0
+86 021 52887820
Fax 37407 0
Email 37407 0
fanwenke@hotmail.com
Contact person for scientific queries
Name 37408 0
Wenke Fan
Address 37408 0
Room 501, No. 24, Lane.1349,Nan Ma Tou Road, Pu Dong New District, Shanghai, P.R.China,200125
Country 37408 0
China
Phone 37408 0
+86 021 52887820
Fax 37408 0
Email 37408 0
fanwenke@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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