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Trial registered on ANZCTR


Registration number
ACTRN12622000150741
Ethics application status
Approved
Date submitted
14/09/2021
Date registered
28/01/2022
Date last updated
27/10/2023
Date data sharing statement initially provided
28/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of therapeutic craft-making activities in treating lower third forearm fracture: a randomized controlled trial
Scientific title
The effectiveness of therapeutic craft-making activities in treating lower third forearm fracture: a randomized controlled trial
Secondary ID [1] 305152 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Third Forearm Fracture 323413 0
Distal Radius Fracture 323414 0
Condition category
Condition code
Injuries and Accidents 320967 320967 0 0
Fractures
Musculoskeletal 321897 321897 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 321898 321898 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will undergo a an extra 10-15 minutes therapeutic craft-making session after receiving standard care treatment. The therapeutic craft-making session will be a one-to-one session, conducted by the researcher with minimum 5 years of experience in hand rehabilitation. The intervention will be commenced after 2-4 weeks post-surgery. Intervention will be delivered twice a week for 6 weeks, with a total of 12 sessions. The researcher will record the participant's attendance for each session. The therapeutic craft-making session will be conducted in a separate room within the Hand and Upper Limb Centre. Participants will perform crafts including air-dry clay art, quilling, batik painting, origami, threading beads, card making, cloth stamping, wooden frame design, sewing, perler beading, braiding, and soap making. Materials that will be used in the intervention are air-dry clay, papers, cloth, cloth dyes, beads, elastic threads, popsicles sticks, glue, perler beads, rope, soap, fragrance, and soap dye.
Intervention code [1] 321558 0
Rehabilitation
Intervention code [2] 322261 0
Treatment: Other
Comparator / control treatment
Control treatment is the standard care that will be received by participant in both control group and intervention group. Standard care will be delivered by a dedicated occupational therapist that have at least 5 years experience in hand rehabilitation. Standard care treatment involves a 1-hour therapy treatment twice a week for 6 weeks. Treatments will include heat therapy/cryotherapy, active and passive mobilization, scar management, ultrasound therapy, and strengthening exercises.
Control group
Active

Outcomes
Primary outcome [1] 329804 0
Disability measured by Quick-Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure
Timepoint [1] 329804 0
Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
Secondary outcome [1] 400287 0
Post-traumatic stress measured by using Impact of Event Scale-Revised (IES-R)
Timepoint [1] 400287 0
Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
Secondary outcome [2] 403883 0
Dexterity measured by using Purdue Pegboard Test
Timepoint [2] 403883 0
Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
Secondary outcome [3] 403886 0
Grip strength measured by using Jamar Dynamometer
Timepoint [3] 403886 0
Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
Secondary outcome [4] 428243 0
Wrist specific disability measured by Patient Rated Wrist Evaluation (PRWE)
Timepoint [4] 428243 0
Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
Secondary outcome [5] 428244 0
Active Range of Motion (AROM) of supination and pronation of the forearm, extension and flexion of the wrist, extension/flexion of all digit's metacarpal phalangeal joints and interphalangeal joints using goniometer
Timepoint [5] 428244 0
Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention

Eligibility
Key inclusion criteria
Patients with lower third forearm fracture involving individual or combined distal radius, distal ulna, distal radioulnar, radiocarpal joint that undergo open reduction internal fixation (ORIF)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with rheumatoid arthritis, multiple limbs or bodily fractures, carpal bone involvement, associated peripheral nerve or/and tendon injury and patient with history of cognitive impairment or psychological condition

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 randomization using random draw
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size for this study is calculated through G* power analysis using ANOVA repeated measures, within-between interaction. Analysis is done with Cohen-f effect size at 0.25 for a medium effect, alpha error at 0.05 and 80% power. Result showed that a total of 34 participants is needed. By adding 10% dropout rate, the required sample size became 38 participants.
Data from the study will be analyzed using the Statistical Package for Social Sciences (SPSS) version 25. Data will be analyzed using chi-square test of independence, independent t-test and mixed model ANOVA

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
26
Final
Recruitment outside Australia
Country [1] 24076 0
Malaysia
State/province [1] 24076 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 309542 0
Self funded/Unfunded
Name [1] 309542 0
Rui Fen Teoh
Country [1] 309542 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia (The National University of Malaysia)
Address
Universiti Kebangsaan Malaysia (National University of Malaysia)
43600 UKM, Bangi, Selangor Darul Ehsan
Country
Malaysia
Secondary sponsor category [1] 310572 0
None
Name [1] 310572 0
Address [1] 310572 0
Country [1] 310572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309323 0
Jawatankuasa Etika Penyelidikan Universiti Kebangsaan Malaysia (Research Ethics Committee, The National University of Malaysia)
Ethics committee address [1] 309323 0
Ethics committee country [1] 309323 0
Malaysia
Date submitted for ethics approval [1] 309323 0
15/06/2020
Approval date [1] 309323 0
02/11/2020
Ethics approval number [1] 309323 0
UKM PPI/111/8/JEP-2020-465
Ethics committee name [2] 309352 0
Pantai Hospital Kuala Lumpur Research and Ethics Committee
Ethics committee address [2] 309352 0
Ethics committee country [2] 309352 0
Malaysia
Date submitted for ethics approval [2] 309352 0
13/08/2020
Approval date [2] 309352 0
15/09/2020
Ethics approval number [2] 309352 0
PHKL-EC-2020-0015

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

Contacts
Principal investigator
Name 113762 0
Dr Siaw Chui Chai
Address 113762 0
Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab), Jalan Raja Muda Abdul Aziz,
50300, Kuala Lumpur
Country 113762 0
Malaysia
Phone 113762 0
+603 9289 7047
Fax 113762 0
Email 113762 0
sc.chai@ukm.edu.my
Contact person for public queries
Name 113763 0
Rui Fen Teoh
Address 113763 0
Hand and Upper Limb Centre, 2nd Floor, Block A,
8, Jalan Bukit Pantai, 59100 Kuala Lumpur,
Country 113763 0
Malaysia
Phone 113763 0
+60322960412
Fax 113763 0
Email 113763 0
teohruifen@gmail.com
Contact person for scientific queries
Name 113764 0
Rui Fen Teoh
Address 113764 0
Hand and Upper Limb Centre, 2nd Floor, Block A,
8, Jalan Bukit Pantai, 59100 Kuala Lumpur,
Country 113764 0
Malaysia
Phone 113764 0
+60322960412
Fax 113764 0
Email 113764 0
teohruifen@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All participants data will be kept confidential and are protected under ethic committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13167Ethical approval    382676-(Uploaded-12-09-2021-22-09-02)-Study-related document.pdf
13168Ethical approval    382676-(Uploaded-12-09-2021-22-09-36)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial2024https://doi.org/10.1186/s13063-024-08008-w
N.B. These documents automatically identified may not have been verified by the study sponsor.