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Trial registered on ANZCTR


Registration number
ACTRN12614000569606
Ethics application status
Approved
Date submitted
23/05/2014
Date registered
28/05/2014
Date last updated
28/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Day to day activities as therapeutic modalities to rehabilitate injured hands
Scientific title
The efficacy of occupation based intervention in comparison with the therapeutic exercise in the rehabilitation of clients with hand injuries
Secondary ID [1] 284649 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand injuries 291965 0
Condition category
Condition code
Musculoskeletal 292315 292315 0 0
Other muscular and skeletal disorders
Injuries and Accidents 292353 292353 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 292354 292354 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of six weeks supervised hand therapy, followed by four weeks of home-based hand therapy. The participants are provided with 30 minutes of therapeutic exercises, and 30 minutes of occupation based intervention in one therapy session, twice a week during the six weeks of supervised hand therapy. In addition, all participants are provided with paraffin bath treatment to prepare the injured hands for active mobilisation. The therapeutic exercises used are similar to the control group. Occupation based intervention consists of three selected occupational tasks; picking up small everyday objects, washing/wiping dishes and typing on a keyboard. The occupational tasks were chosen based on the therapeutic benefits that were described by Malaysian occupational therapists in an unpublished study by the investigator. All the therapy sessions are administered by an occupational therapist. The intervention is then followed by four weeks of home-based hand therapy, two hours per week for four weeks. The participants are asked to incorporate these tasks into their occupations for daily living. For instance, they are asked to wash/wipe dishes after a meal, type any tasks using the keyboard (homework/office work/ replying to emails/chatting) and pick up everyday small objects that related to their day to day activities. All participants are provided with a checklist diary to remind them to complete the program.
Intervention code [1] 289431 0
Rehabilitation
Comparator / control treatment
Similarly to the intervention group, the participants in the control group are provided with six weeks of supervised hand therapy, followed by four weeks of home-based hand therapy. During the six weeks of supervised hand therapy, the participants are only provided with 60 minutes of therapeutic exercises in one session, twice a week, after the application of paraffin bath. The therapeutic exercises used are range of motion (ROM) exercises (passive, active assisted and active) and strengthening activities. ROM and strengthening modalities such as theraputty, digiflex and hand helper are concurrently used during the therapy session. The participants are gradually taught how to carry out the therapeutic exercises at home during the six weeks of supervised hand therapy. Therapeutic exercise modalities are provided to each participant for the purpose of home-based hand therapy. They are required to complete two hours of these tasks per week, for four weeks, as part of their home program treatment. All participants are provided with a checklist diary to remind them to complete the program.
Control group
Active

Outcomes
Primary outcome [1] 292188 0
Disability/symptom following hand injuries is measured by using the Disability of Arm, Shoulder and Hand (DASH). An English and Malay version of DASH is used in the study according to the participants’ preference. The participant is asked to complete the DASH questionnaire at the end of each evaluation session.
Timepoint [1] 292188 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy
Secondary outcome [1] 308395 0
Total Active Motion (TAM) is measured by using a finger goniometer while the wrist is in the neutral position and the forearm is pronated. Each joint of the digits and thumb is measured individually. The sum of all active flexion measurements of digits joints (MCP, PIP and DIP) and thumb joints (MCP, IP ) is calculated and the sum of all extension deficits of the digits and thumb is subtracted from it, to compute the TAM.
Timepoint [1] 308395 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy
Secondary outcome [2] 308416 0
Fine and gross dexterity are measured by using the Perdue Pegboard test. The test has five subtests; Right Hand (RH); Left Hand (LH), Both Hands (BH); Right+Left+Both (RLBH) and; Assembly. Three measurements are taken for each subtest and the average is calculated. The test is conducted according to the manual booklet of Purdue pegboard test model 32020.
Timepoint [2] 308416 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy
Secondary outcome [3] 308418 0
Grip strength is measured by using a Jamar hand dynamometer.The participants are instructed to sit with shoulder adducted and neutrally rotated, elbow flexed at 90 degree, forearm in neutral position and wrist between 0 to 30 degree extension. The grasp setting is set at the second level to give maximal contraction and allow for full function of profundus, superficialis and interossoues muscles. Three measurements are taken from each participant and the average is calculated for the analysis.
Timepoint [3] 308418 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy
Secondary outcome [4] 308419 0
Pinch strength is measured by using a B&L pinch gauge. The position of the participant is similar to that used in measuring grip strength. Key pinch is selected to measure pinch strength because it is the strongest type of pinch and easier to test. Key pinch is also known as lateral pinch; it is tested when the pinch gauge is positioned between the pad of the thumb and the radial side of middle phalanx of the index finger. As for grip strength, the test is repeated for three trials, and the average is calculated for the analysis.
Timepoint [4] 308419 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy
Secondary outcome [5] 308420 0
Occupational performance and satisfaction with the occupational performance are assessed by using the Canadian Occupational Performance Measure (COPM). The participants are interviewed to identify the five most important occupational performance issues that impacted on their life following the hand injury. A scale of 1 to 10 is used, where 10 is the most important goal needed to be attained by the participants. Using the same scale, the participants are asked to rate the performance of the occupations and satisfaction with their performance. Both the sum of performance and satisfaction scores are divided by the number of identified problems to compute the overall score for analysis.
Timepoint [5] 308420 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy
Secondary outcome [6] 308421 0
Neuropathic pain following hand injury is measured using the Graphic Numerical Rating Scale (GNRS), where zero indicates no pain and 10 indicates the worst pain possible. The participants are asked to circle the number representing their level of pain on a graphic scale.
Timepoint [6] 308421 0
Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy

Eligibility
Key inclusion criteria
Potential participants are recruited from the hand out-patient occupational therapy clinic according to the following inclusion criteria:(1) Experienced bone, tendon and peripheral nerve injury to the hand, wrist and forearm; (2) Not on any hand therapy protocol (e.g.; flexor/extensor tendon protocol, post fracture stabilization, etc.); (3) No communication and cognitive deficits; (4) Able to read and write either in Malay or English and; (5) consent to take part in the study.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who had; (1) Bilateral hand injuries (2) Brachial plexus, shoulder or elbow injury; (3) Repetitive strain injury (e.g. tendinitis, carpal tunnel syndrome, de quervain syndrome, etc.) and; (4) Burn injury are excluded from this study

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)
A research assistant screens the eligible clients, and offers an opportunity to participate in the study. Verbal and written information about the study are given to the clients, and consent is obtained from the participants who agreed to take part in the study. The participants who consent to take part in the study are randomly allocated into the intervention (OBI) group and the control (TE) group using a random number table, which is prepared in advanced before the enrollment of the first participant. One large permuted-block method are used to balance the number of participants in the OBI and TE group. The assistant is also responsible to allocate the participants consecutively into either to the OBI or TE group by using the random number table. Allocation to the groups is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random number table was generated via http://www.random.org/sequences/?min=1&max=46&col=2&format=html&rnd=new.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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 power analysis is calculated based on the findings from a comparable study (Guzelkucuk et al., 2007). Thirty-eight participants are required to detect a significant group difference (p<.05) of 15 DASH score with 80% power. Assuming a maximum 20% drop-out rate as suggested in a recent systematic review, it follows that 46 participants are needed for the study.

All data are statistically analysed using the Statistical Package for Social Sciences (SPSS) version 22.0 for windows. Tests included t-test, chi-square and fisher’s exact test to determine whether differences existed between groups for participants’ characteristics. Three sets of t-tests are also used to compare the groups at baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy. Possible confounding effects which might have influenced therapeutic outcomes are examined using linear mixed models. It also allows the researcher to examine whether the effect of treatment varied among classes of participants. The participants’ characteristics such as age, sex, duration of injury, injured hand, cause of injury, number of digit affected, occupation and type of injury are each treated as fixed effects to determine whether they influenced therapeutic outcomes, using individual subject as a random effect. The statistical significant level is set at p < 0.05 (two-tailed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2013
Date of last participant enrolment
Anticipated
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 6069 0
Malaysia
State/province [1] 6069 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 289284 0
University
Name [1] 289284 0
Graduate Research School, Faculty of Medicine and Molecular Sciences, James Cook University, Australia
Country [1] 289284 0
Australia
Funding source category [2] 289286 0
University
Name [2] 289286 0
Mara University of Technology
Country [2] 289286 0
Malaysia
Primary sponsor type
University
Name
James Cook University
Address
School of Public Health, Tropical Medicine and Reahbilitation Sciences, James Cook University, Townsville, QLD 4111
Country
Australia
Secondary sponsor category [1] 287957 0
Individual
Name [1] 287957 0
Ahmad Zamir Che Daud
Address [1] 287957 0
No 29, Lorong Haji Che Su,
Kampung Kemumin, 16100 Kota Bharu, Kelantan
Country [1] 287957 0
Malaysia
Other collaborator category [1] 277973 0
Hospital
Name [1] 277973 0
Kuala Lumpur Hospital
Address [1] 277973 0
Hand and Traumatology Unit,
Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur
Country [1] 277973 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291051 0
Human Research Ethics Committee
Ethics committee address [1] 291051 0
Ethics committee country [1] 291051 0
Australia
Date submitted for ethics approval [1] 291051 0
Approval date [1] 291051 0
14/12/2012
Ethics approval number [1] 291051 0
H4901
Ethics committee name [2] 291052 0
Medical Research and Ethics Committee
Ethics committee address [2] 291052 0
Ethics committee country [2] 291052 0
Malaysia
Date submitted for ethics approval [2] 291052 0
Approval date [2] 291052 0
05/10/2012
Ethics approval number [2] 291052 0
NMRR-12-660-11901

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

Contacts
Principal investigator
Name 48614 0
Mr Ahmad Zamir Che Daud
Address 48614 0
Discipline of Occupational Therapy,
School of Public Health, Tropical Medicine and Rehabilitation Sciences, James Cook University, Townsville, QLD 4811
Country 48614 0
Australia
Phone 48614 0
61403291967
Fax 48614 0
Email 48614 0
ahmadzamir.chedaud@my.jcu.edu.au
Contact person for public queries
Name 48615 0
Ahmad Zamir Che Daud
Address 48615 0
Discipline of Occupational Therapy,
School of Public Health, Tropical Medicine and Rehabilitation Sciences, James Cook University, Townsville, QLD 4811
Country 48615 0
Australia
Phone 48615 0
61403291967
Fax 48615 0
Email 48615 0
ahmadzamir.chedaud@my.jcu.edu.au
Contact person for scientific queries
Name 48616 0
Matthew Yau
Address 48616 0
Discipline of Occupational Therapy,
School of Public Health, Tropical Medicine and Rehabilitation Sciences, James Cook University, Townsville, QLD 4811
Country 48616 0
Australia
Phone 48616 0
+61 7 478 16242
Fax 48616 0
Email 48616 0
matthew.yau@jcu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntegration of occupation based intervention in hand injury rehabilitation: A Randomized Controlled Trial.2016https://dx.doi.org/10.1016/j.jht.2015.09.004
N.B. These documents automatically identified may not have been verified by the study sponsor.