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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614000569606
Date of registration: 28/05/2014
Prospective Registration: No
Primary sponsor: James Cook University
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
Date of first enrolment: 08/04/2013
Target sample size: 46
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614000569606.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Malaysia
Contacts
Name: Mr Ahmad Zamir Che Daud   
Address:  Discipline of Occupational Therapy, School of Public Health, Tropical Medicine and Rehabilitation Sciences, James Cook University, Townsville, QLD 4811 Australia
Telephone: 61403291967
Email: ahmadzamir.chedaud@my.jcu.edu.au
Affiliation: 
Name: Prof Matthew Yau   
Address:  Discipline of Occupational Therapy, School of Public Health, Tropical Medicine and Rehabilitation Sciences, James Cook University, Townsville, QLD 4811 Australia
Telephone: +61 7 478 16242
Email: matthew.yau@jcu.edu.au
Affiliation: 
Key inclusion & exclusion criteria
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.
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

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Musculoskeletal - Other muscular and skeletal disorders
Physical Medicine / Rehabilitation - Occupational therapy
Injuries and Accidents - Other injuries and accidents
Hand injuries;
Hand injuries
Intervention(s)
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.
Primary Outcome(s)
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.[Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
Secondary Outcome(s)
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. [Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
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. [Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
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. [Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
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.[Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
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.[Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
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.
[Baseline, post six weeks of supervised hand therapy and post four weeks of home-based hand therapy]
Secondary ID(s)
None
Source(s) of Monetary Support
Mara University of Technology
Graduate Research School, Faculty of Medicine and Molecular Sciences, James Cook University, Australia
Secondary Sponsor(s)
Ahmad Zamir Che Daud
Ethics review
Status: Approved
Approval date:
Contact:
Human Research Ethics Committee
Status: Approved
Approval date:
Contact:
Medical Research and Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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