Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00643

2 Trial Registration Date

2018-12-11

i Registration Status

Prospective

3 Secondary IDs

IRB no: 2018.470

4 Source(s) of Funding

No

5 Primary Sponsor

No

6 Secondary Sponsor

No

Function

Not Applicable

Please specify

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

i Name

Ka Ling Chan

ii Address

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong

iii Phone

67341077

iv Email

chankaling22042003@yahoo.com.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Chan Ka Ling

ii Address

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong

iii Phone

67341077

iv Email

1155105028@link.cuhk.edu.hk

v Affiliation

Master of Science in Musculoskeletal Medicine, Rehabilitation and Geriatric Orthopaedics, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Which is essential in “Remind to move” treatment in children with hemiplegic cerebral palsy: Awareness or a combination with intensive customized exercise?

10 Public Title

Which is essential in “Remind to move” treatment in children with hemiplegic cerebral palsy: Awareness or a combination with intensive customized exercise?

i Public Title in Chinese 研究名稱

提醒治療法在半身痙攣學童的患側手部功能研究: 感知提示增強患側注意力或是配合密集運動, 哪樣較重要?

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-11-30

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.470

14 Medical Condition Being Studied

Hemiplegic Cerebral Palsy

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Remind to move treatment was recently developed for children with hemiplegic cerebral palsy in Hong Kong to improve their hand functions and increase spontaneous hand use in the affected side. It is a user-friendly treatment which is easy and convenient to carry out without restraint of less affected hand as compared to CIMT. RTM involves two treatment elements: 1. sensory cueing on the affected arm 2.repetitive bimanual or unimanual upper limb exercise. A light weight sensory cueing wrist watch device was worn on the more affected arm in the children. It vibrated at fixed interval to increase the child’s attention on the hemiplegic arm, followed by repetitive upper limb exercise to increase use of it.

iii Dosage form of the intervention

vibration and exercise

iv Dosage of the intervention

The wristwatch will vibrate every 15 minutes during intervention period. The subjects will receive vibration and need to do individualized exercise afterwards.

v Duration of the intervention

3 weeks

vi Frequency of the intervention

around 6 hours/day, 5 days per week, in total 3 weeks

16 Comparative Treatments

i Description/ name of comparative treatments

Interval vibration emitted by the sensory cueing wristwatch device on the affected hand of subjects

ii Dosage form of the comparative treatments

Vibration

iii Dosage of the comparative treatments

The wristwatch will vibrate every 15 minutes during intervention period

iv Duration of the comparative treatments

3 weeks

v Frequency of the comparative treatments

around 6 hours/day, 5 days per week, in total 3 weeks

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Being diagnosed with hemiplegic cerebral palsy

Being 6 to 18 years of age

Having the ability to follow instruction

Having the ability to grasp and release light objects

Having impairment of hand function at levels I to III of the Manual Activity Classification System

Ability to extend the wrist at least 20° and the fingers at least 10° from full flexion at metacarpal joints

ii Exclusion Criteria

severe cognitive impairment

Severe visual impairment

having predominant spasticity more than Grade 3 of the Modified Ashworth Scalein wrist and finger flexors, forearm pronators, and/or thumb adductors

Severe sensory impairment that cannot sense the vibration emitted by the wristwatch device

having received Botulinum neurotoxin injections and/or surgical interventions in the 6-month period before the study

iii Age Minimum

6

iv Age Maximum

18

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Stratified randomization

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

to investigate: 1. whether continuously increasing awareness on the more affected arm by cueing it in the form of vibration at a fixed interval can improve hand functions and increase spontaneous hand use in hemiplegic arm; and 2. whether providing sensory cueing to hemiplegic arm only can achieve c

20 Anticipated trial start date

2018-12-17

21 Target Sample Size

12

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

hand functions

ii The metric or method of measurement used

Bruininks Osteretsky Test of Motor Proficiency (2nd edition), Jebsen-Taylor Hand Function Test

iii The timepoint(s) of primary interest

Pre-test, immediate post-test, post-test after 3 weeks of intervention

Primary Outcome

i The Name of the outcome

The upper limb impairment measures

ii The metric or method of measurement used

include power grip and active range of motion on the affected upper limb

iii The timepoint(s) of primary interest

Pre-test, immediate post-test, post-test after 3 weeks of intervention

24 Secondary Outcome

i The Name of the outcome

Spontaneous use of affected hand in daily life

ii The metric or method of measurement used

the ratio of duration of movement of the affected hand to the duration of movement of the unaffected hand which is being measured by the built-in accelerator in the wristwatch device, Carergiver Functional Use Survey

iii The timepoint(s) of primary interest

Pre-test, immediate post-test, post-test after 3 weeks of intervention

Secondary Outcome

i The Name of the outcome

Individual goal achievement

ii The metric or method of measurement used

Goal Attainment Scaling

iii The timepoint(s) of primary interest

Pre-test, immediate post-test, post-test after 3 weeks of intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-01-29

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-12-11