Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00429

2 Trial Registration Date

2014-08-04

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.221

4 Source(s) of Funding

Division of Neurology, Department of Medicine & Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong

5 Primary Sponsor

Division of Neurology, Department of Medicine & Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Roxanna LIU

ii Address

Division of Neurology, Department of Medicine & Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong;

iii Phone

852 2632 3877

iv Email

roxannaliu@cuhk.edu.hk

v Affiliation

Division of Neurology, Department of Medicine & Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Vincent CT MOK

ii Address

Division of Neurology, Department of Medicine & Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong;

iii Phone

852 2632 3523

iv Email

vctmok@cuhk.edu.hk

v Affiliation

Division of Neurology, Department of Medicine & Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Pilot study on Microelectronic Neural Bridge in improving rehabilitation outcome for stroke patients with upper limb paresis

10 Public Title

Pilot study on Microelectronic Neural Bridge in improving rehabilitation outcome for stroke patients with upper limb paresis

i Public Title in Chinese 研究名稱

微電子神經橋對提高中風患者上肢輕癱康復效果的試驗研究

11 Short Title (Optional)

NA

12 Countries of Recruitment

Hong Kong, China SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-05-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

stroke

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Microelectronic Neural Bridge Training

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The Contralaterally Controlled Functional Electrical Stimulation (CCFES) is a system, which detects and converts a control signal from the healthy side of the body to regulate the intensity of electrical stimulation delivered to the corresponding muscles of the paretic limb on the affected side of the body.
Our collaborator, the ASTRI group has developed a similar system named the Microelectronic Neural Bridge (MNB). MNB senses the electromyography (EMG) signal of a particular group of muscles. Such signal is channeled to a processor, which generates electrical stimulation to the corresponding muscles in the paretic limb, in much the same way the CCFES system does. Training the paretic limb for 2 weeks.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Aged 18 or above
2. Within 6 months post stroke (both ischemic and hemorrhagic)
3. Manual muscle grade of 3 or less for finger extensors
4. Functional hand opening in response to electrical stimulation
5. Cognitively capable of using the MNB system as instructed

ii Exclusion Criteria

1. Had intramuscular botulinum toxin injections in any upper-extremity muscle within 3 months before enrollment or at any time during the study
2. Apraxic
3. Had uncompensated hemineglect
4. Had uncompensated hemianopsia
5. Had pacemaker in situ
6. Had metal implants in situ
7. Had recent upper limb fractures

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-08-16

21 Target Sample Size

5

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

1. Maximum voluntary finger extension angle
2. Hand grip strength as indicated by dynamometer
3. Box and Block test
At Baseline & Week 2 after training

24 Secondary Outcome

NA

25 Study Information/Publication

i Study Information/Publication Available?

Yes

ii Link to Study Information/Publication

NA

26 Last Update Date

2015-09-08

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-14005053

28 Date of Registration in Primary Registry

2014-08-05

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

None

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Trial History Detail on 2014-08-15