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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
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Scientific title
The effectiveness of therapeutic craft-making activities in treating lower third forearm fracture: a randomized controlled trial
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Secondary ID [1]
305152
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lower Third Forearm Fracture
323413
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Distal Radius Fracture
323414
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Condition category
Condition code
Injuries and Accidents
320967
320967
0
0
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Fractures
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Musculoskeletal
321897
321897
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
321898
321898
0
0
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Occupational therapy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
321558
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Rehabilitation
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Intervention code [2]
322261
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
329804
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Disability measured by Quick-Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure
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Assessment method [1]
329804
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Timepoint [1]
329804
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Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
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Secondary outcome [1]
400287
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Post-traumatic stress measured by using Impact of Event Scale-Revised (IES-R)
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Assessment method [1]
400287
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Timepoint [1]
400287
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Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
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Secondary outcome [2]
403883
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Dexterity measured by using Purdue Pegboard Test
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Assessment method [2]
403883
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Timepoint [2]
403883
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Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
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Secondary outcome [3]
403886
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Grip strength measured by using Jamar Dynamometer
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Assessment method [3]
403886
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Timepoint [3]
403886
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Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
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Secondary outcome [4]
428243
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Wrist specific disability measured by Patient Rated Wrist Evaluation (PRWE)
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Assessment method [4]
428243
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Timepoint [4]
428243
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Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
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Secondary outcome [5]
428244
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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
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Assessment method [5]
428244
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Timepoint [5]
428244
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Baseline, before commencement of first therapy session (2-4 weeks post-operation) and reassessment after completing 6 weeks/12 sessions of intervention
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using random draw
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
12/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
38
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Accrual to date
26
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Final
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Recruitment outside Australia
Country [1]
24076
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Malaysia
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State/province [1]
24076
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Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
309542
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Self funded/Unfunded
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Name [1]
309542
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Rui Fen Teoh
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Address [1]
309542
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106, Jalan Burung Garuda, Taman Bukit Maluri,
52100 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
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Country [1]
309542
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Malaysia
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Primary sponsor type
University
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Name
Universiti Kebangsaan Malaysia (The National University of Malaysia)
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Address
Universiti Kebangsaan Malaysia (National University of Malaysia)
43600 UKM, Bangi, Selangor Darul Ehsan
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Country
Malaysia
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Secondary sponsor category [1]
310572
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None
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Name [1]
310572
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Address [1]
310572
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Country [1]
310572
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
309323
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Jawatankuasa Etika Penyelidikan Universiti Kebangsaan Malaysia (Research Ethics Committee, The National University of Malaysia)
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Ethics committee address [1]
309323
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Tingkat 1, Blok Klinikal, Pusat Perubatan UKM Jalan Yaakob Latiff, Bandar Tun Razak 56000 Cheras, Kuala Lumpur
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Ethics committee country [1]
309323
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Malaysia
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Date submitted for ethics approval [1]
309323
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15/06/2020
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Approval date [1]
309323
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02/11/2020
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Ethics approval number [1]
309323
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UKM PPI/111/8/JEP-2020-465
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Ethics committee name [2]
309352
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Pantai Hospital Kuala Lumpur Research and Ethics Committee
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Ethics committee address [2]
309352
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8, Jalan Bukit Pantai, Bangsar, 59100 Kuala Lumpur
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Ethics committee country [2]
309352
0
Malaysia
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Date submitted for ethics approval [2]
309352
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13/08/2020
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Approval date [2]
309352
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15/09/2020
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Ethics approval number [2]
309352
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PHKL-EC-2020-0015
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Summary
Brief summary
Upper limb fracture is conventionally treated using splint, standard modalities, and soft tissue manipulation which offer little psychological benefits. Craft, as the first therapeutic tool used by occupational therapist (OT) has played a significant role since the early history of the profession. Craft can effectively intervene both physical and psychological conditions by providing motivation and foster feelings of satisfaction and hope; and regulate psychophysiological and emotional affects by lowering pain and anxiety. OT that works in the hand therapy field has reduced the use of craft as an intervention due to the lack of documentation and inadequate research. This study aims to determine the benefits of therapeutic craft in addressing the disability, physical impairment and the psychological impact after lower third forearm fracture. This study hypothesised that patients who received therapeutic craft-making session will have greater reduction in disability and post-traumatic stress as well as greater improvement in physical performance. This is a randomized control trial study where participant will be randomly allocated to the control group and intervention group. Patients that undergone surgical treatment for their wrist fracture will be recruited into this study after 2 weeks post-surgery. However, 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 will be excluded. Participants will undergo 2 therapy sessions per week for 6 weeks (12 sessions). Assessment will be done prior to the commencement of the first therapy session and after the 12th session. Assessment of the disability and post-traumatic stress will be done using questionnaire while physical performance will be assess using clinical assessment tools.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
113762
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Dr Siaw Chui Chai
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Address
113762
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Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab), Jalan Raja Muda Abdul Aziz,
50300, Kuala Lumpur
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Country
113762
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Malaysia
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Phone
113762
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+603 9289 7047
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Fax
113762
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Email
113762
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[email protected]
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Contact person for public queries
Name
113763
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Rui Fen Teoh
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Address
113763
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Hand and Upper Limb Centre, 2nd Floor, Block A,
8, Jalan Bukit Pantai, 59100 Kuala Lumpur,
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Country
113763
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Malaysia
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Phone
113763
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+60322960412
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Fax
113763
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Email
113763
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[email protected]
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Contact person for scientific queries
Name
113764
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Rui Fen Teoh
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Address
113764
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Hand and Upper Limb Centre, 2nd Floor, Block A,
8, Jalan Bukit Pantai, 59100 Kuala Lumpur,
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Country
113764
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Malaysia
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Phone
113764
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+60322960412
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Fax
113764
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Email
113764
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All participants data will be kept confidential and are protected under ethic committee
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
13167
Ethical approval
382676-(Uploaded-12-09-2021-22-09-02)-Study-related document.pdf
13168
Ethical 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
Source
Title
Year of Publication
DOI
Dimensions AI
The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial
2024
https://doi.org/10.1186/s13063-024-08008-w
N.B. These documents automatically identified may not have been verified by the study sponsor.
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