Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000413729
Ethics application status
Approved
Date submitted
10/01/2022
Date registered
10/03/2022
Date last updated
10/03/2022
Date data sharing statement initially provided
10/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness Of Single Joint Hybrid Assistive Limb (HAL-SJ) Robotic Exoskeleton Therapy In Improving Functional Outcomes Among Workers With Wrist Fractures: A Randomized Controlled Trial
Scientific title
The Effectiveness Of Single Joint Hybrid Assistive Limb (HAL-SJ) Robotic Exoskeleton Therapy In Improving Functional Outcomes Among Workers With Wrist Fractures: A Randomized Controlled Trial
Secondary ID [1] 306094 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wrist Fractures 324756 0
Condition category
Condition code
Musculoskeletal 322207 322207 0 0
Other muscular and skeletal disorders
Injuries and Accidents 322947 322947 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The HAL is a hybrid control system that consists of a ‘Cybernic Voluntary Control (Bio-Cybernic Control)’ and ‘Cybernic Autonomous Control (Cybernic Robot Control)’. The cybernic control system can provide suitable physical support to wearers with various conditions including both healthy persons and physically challenged persons by using the two types of algorithms as complementary controls. The Cybernic Voluntary Control provides physical supports/actions according to the operator’s voluntary intention caused by the bioelectrical signals including muscle activity. The power units of HAL generate power assist torque by amplifying the wearer’s own joint torque estimated from his/her bioelectrical signals, and the support motions are consequently controlled. Bioelectrical signals, including myoelectricity, are useful and reliable information to estimate a human’s motion intentions because the signals are measured just before corresponding visible muscle activities. Thus, the wearer receives physical support directly by an unconscious interface using the bioelectrical signals. In contrary, the Cybernic Autonomous Control autonomously provides a desired functional motion generated according to the wearer’s body constitution, conditions, and purposes of motion support

During the intervention session, the participant will perform repetitions of different wrist movements such as extension, flexion, supination and pronation whilst assisted by a robot arm which receives feedback from the bioelectrical signals generated by the muscle movement.

The researcher is a certified HAL-SJ operator accredited by Cyberdyne Inc. and is competent to conduct the robotic intervention for the intervention group.

Participants will be selected based on the inclusion and exclusion criteria. The selected participants will be informed about the study and only be included in the study after giving their informed consent.

The intervention group will receive a 60-minutes HAL-SJ robotic therapy session conducted by the researcher daily on a 5-day/week routine basis within two hours after the conventional therapy sessions.

Week 1 Intervention Protocol
HAL-SJ – Gentle Mode
i) Extension: 50 repetitions; 3 sets
ii) Flexion: 50 repetitions; 3 set
iii) Supination: 50 repetitions; 3 sets
iv) Pronation: 50 repetitions; 3 sets

Parameters:
Assist Gain: 75-100
Assist Level: x1
Flexion/Extension Signal Balance: 100%/100%
Active/Relax Phase:
10 seconds/10 seconds

Week 2 Intervention Protocol
HAL-SJ – Gentle Mode
i) Extension: 50 repetitions; 3 sets
ii) Flexion: 50 repetitions; 3 sets
iii) Supination: 50 repetitions; 3 sets
iv) Pronation: 50 repetitions; 3 sets

Parameters:
Assist Gain: 50-75
Assist Level: x1

Flexion/Extension Signal Balance:
100% : 100%
Active/Relax Phase:
10 seconds/10 seconds


Week 3 Intervention Protocol
HAL-SJ – Gentle Mode
i) Extension: 50 repetitions; 3 sets
ii) Flexion: 50 repetitions; 3 sets
iii) Supination: 50 repetitions; 3 sets
iv) Pronation: 50 repetitions; 3 sets

Parameters:
Assist Gain: 25-50
Assist Level: x1
Flexion/Extension Signal Balance:
i) 50% : 100%
ii) 100% : 50%
Active/Relax Phase:
10 seconds/10 seconds

Week 4 Intervention Protocol
HAL-SJ – Gentle Mode
i) Extension: 50 repetitions; 3 sets
ii) Flexion: 50 repetitions; 3 sets
iii) Supination: 50 repetitions; 3 sets
iv) Pronation: 50 repetitions; 3 sets

Parameters:
Assist Gain: 0-25
Assist Level: x1
Flexion/Ext Signal Balance:
i) 25% : 100%
ii) 100% : 25%
Active/Relax Phase:
10 seconds/10 seconds
Intervention code [1] 322504 0
Treatment: Devices
Comparator / control treatment
Participants from the control and intervention groups will be receiving conventional Physiotherapy and Occupational Therapy that includes splinting, scar management, edema management, physical agent modalities, e.g. hot/cold pack, ultrasound, Transcutaneous Electrical Nerve Stimulation (T.E.N.S.), Neuromuscular Electrical Stimulation (N.M.E.S.), passive/active stretching, joint mobilization, strengthening exercises, and hand function training.

Each participant from both the control and intervention groups will receive two conventional therapy sessions daily that include an occupational therapy session and a physiotherapy session on a 5-day/week routine basis. Each occupational therapy and physiotherapy session will last for 90 minutes respectively.

Week 1 Control Treatment
Interventions aimed at joint mobility and to reduce pain:

Occupational Therapy:
Active and passive range of motion
exercise of digits, elbow, and
shoulder
Active range of motion exercise of
wrist and forearm rotation
Tendon gliding exercise
Dexterity exercise

Physiotherapy:
Joint mobilization
Soft tissue mobilization
Retrograde massage
Heat/Cold modalities
Ultrasound
Electrical stimulation

Week 2 Control Treatment
Interventions aimed at joint mobility and pain

PLUS
Occupational Therapy:
Functional activities training

Physiotherapy
Isometric strengthening exercises
Isotonic strengthening exercises


Week 3 Control Treatment
Interventions aimed at joint mobility and pain

PLUS
Occupational Therapy:
Functional activities training

Physiotherapy:
Isometric strengthening exercises
Isotonic strengthening exercises
Progressive resisted exercises
Open kinetic chain activities
Closed kinetic chain activities


Week 4 Control Treatment
Interventions aimed at joint mobility and pain

PLUS
Occupational Therapy:
Work activity simulation
Work conditioning
Work hardening

Physiotherapy:
Isometric strengthening exercises
Isotonic strengthening exercises
Progressive resisted exercises
Open kinetic chain activities
Closed kinetic chain activities
Control group
Active

Outcomes
Primary outcome [1] 330066 0
Primary outcome: Difference in term of functional level between the intervention and control groups

Instrument: Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Timepoint [1] 330066 0
At baseline and 4 weeks after the commencement of the intervention
Primary outcome [2] 330067 0
Primary outcome: Difference in term of work readiness between the intervention and control group

Instrument: Lam Assessment on Stages of Employment Readiness (LASER)
Timepoint [2] 330067 0
At baseline and 4 weeks after commencement of the intervention
Primary outcome [3] 330068 0
Difference in pain levels assessed with Visual Analogue Scale
Timepoint [3] 330068 0
At baseline and 4 weeks after the commencement of the intervention
Secondary outcome [1] 404787 0
Difference in grip strength assessed with a hand dynamometer
Timepoint [1] 404787 0
At baseline and 4 weeks after the commencement of the intervention
Secondary outcome [2] 406577 0
Difference in pinch strength assessed with pinch gauge
Timepoint [2] 406577 0
At baseline and 4 weeks after the commencement of the intervention
Secondary outcome [3] 406578 0
Difference in range of motion assessed with goniometer
Timepoint [3] 406578 0
At baseline and 4 weeks after the commencement of the intervention
Secondary outcome [4] 406579 0
Hand dexterity assessed with Purdue Pegboard
Timepoint [4] 406579 0
At baseline and 4 weeks after the commencement of the intervention
Secondary outcome [5] 406580 0
Hand dexterity assessed with Block and Box Test
Timepoint [5] 406580 0
At baseline and 4 weeks after the commencement of the intervention

Eligibility
Key inclusion criteria
a. SOCSO insured Malaysian workers who are on medical leave; have not returned to work; and receiving rehabilitation program at SOCSO Tun Razak Rehabilitation Centre, Melaka

b. Wrist fracture involving individual or combined distal radius, distal ulna, distal radioulnar, radiocarpal joint

c. Extraarticular fracture, partial articular fracture, and/or complete articular
fracture
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Aged below 18 years old or above 60 years old (based on SOCSO scheme)
b. Multiple limbs or bodily fractures in addition to wrist fracture
c. Carpal bone involvement
d. Associated peripheral nerve or/and tendon injuries to the affected upper limb
e. Associated neurological conditions related to the central nervous system
f. Cognitive impairment or psychiatric condition
g. Severe and uncontrolled medical conditions e.g. cardiovascular disorders, respiratory disorders, cancer
h. Cardiac pacemaker
i. Skin disorders e.g. eczema, psoriasis, open would etc. of the affected forearm and hand that prevent electrode placements
j. Severe contracture of the affected wrist joint
k. Forearm size that is not fit to wear the Single Joint Hybrid Assistive Limb (HAL-SJ) robotic exoskeleton

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is calculated by using the G* power analysis. Analysis was done to test the difference between two independent groups using one tail test, effect size of 0.8 and alpha error of 0.05. Result showed that a total of 42 participants are needed to achieve a power of 80%.

All data will be analysed using the Statistical Package for Social Sciences (SPSS) version 25. The study will use both descriptive and inferential statistics to analyse the data. Descriptive analysis for categorical data including gender, marital status, hand dominance, types of medical management and intervention, type of wrist fractures, educational level, employment status, and type of SOCSO compensation scheme will be expressed in frequency, percentage or/and proportion. Descriptive statistics for continuous data including age, DASH, pain, grip and pinch strength, wrist and finger ROM, hand dexterity, and work readiness scores will be expressed in mean, standard deviation, maximum, and minimum if the data is normally distributed or in median and inter-quartile range if the data in not normally distributed. The Shapiro-Wilks test will be used to test the normality of the continuous data.

The categorical data will be tested by using the chi-square test of independence while the independent sample t-test or Mann-Whitney U test will be used to test the continuous data. The chi-square test of independence will be used to test the difference between the baseline’s categorical data of both the control and intervention groups, which include gender, marital status, hand dominance, type of medical management and intervention, type of wrist fractures, educational level, employment status, and type of SOCSO compensation scheme. The independent sample t-test and the Mann-Whitney U test will be used to determine if there is a significant difference between the control and intervention groups in term of baseline characteristics (age), functional level (DASH score), physical performance (pain, grip and pinch strength, wrist and finger ROM, hand dexterity) and work readiness data depending on the normality status of these continuous data.

Repeated measure ANOVA will be used to test all the research hypotheses by evaluating the mean differences in treatment outcomes between the groups at baseline and after 4 weeks of intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2022
Actual
Date of last participant enrolment
Anticipated
15/03/2023
Actual
Date of last data collection
Anticipated
15/07/2023
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 24485 0
Malaysia
State/province [1] 24485 0
Malacca

Funding & Sponsors
Funding source category [1] 310435 0
Self funded/Unfunded
Name [1] 310435 0
Tan Eng Wah
Country [1] 310435 0
Malaysia
Primary sponsor type
Individual
Name
Chai Siaw Chui
Address
Universiti Kebangsaan Malaysia, Fakulti Sains Kesihatan
Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 312092 0
University
Name [1] 312092 0
Universiti kebangsaan Malaysia
Address [1] 312092 0
Universiti Kebangsaan Malaysia, Fakulti Sains Kesihatan
Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country [1] 312092 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310074 0
Secretariat of Research Ethics Universiti Kebangsaan Malaysia (UKM)
Ethics committee address [1] 310074 0
Ethics committee country [1] 310074 0
Malaysia
Date submitted for ethics approval [1] 310074 0
08/03/2021
Approval date [1] 310074 0
28/06/2021
Ethics approval number [1] 310074 0
UKM PPI/111/8/JEP-2021-201

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116398 0
Dr Chai Siaw Chui
Address 116398 0
Universiti Kebangsaan Malaysia Faculty of Health Sciences,
Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country 116398 0
Malaysia
Phone 116398 0
+60166605549
Fax 116398 0
Email 116398 0
[email protected]
Contact person for public queries
Name 116399 0
Chai Siaw Chui
Address 116399 0
Universiti Kebangsaan Malaysia Faculty of Health Sciences,
Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country 116399 0
Malaysia
Phone 116399 0
+60166605549
Fax 116399 0
Email 116399 0
[email protected]
Contact person for scientific queries
Name 116400 0
Chai Siaw Chui
Address 116400 0
Universiti Kebangsaan Malaysia Faculty of Health Sciences,
Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country 116400 0
Malaysia
Phone 116400 0
+60166605549
Fax 116400 0
Email 116400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
1) Demographic data
2) Outcome/scores of research parameters
When will data be available (start and end dates)?
immediately following publication, no end date
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Email: [email protected]

Email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14630Study protocol  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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