Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000530325
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
15/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial to investigate whether providing a home exercise program on DVD improves compliance with patients who have hand injuries
Scientific title
Does providing patients who have hand injuries with a home exercise program on DVD and brochures improve compliance when compared to providing brochures only
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand injuries 3688 0
Condition category
Condition code
Musculoskeletal 3854 3854 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of home exercise program or protocol on DVD as well as brochure. There are seven hand therapy protocols that have been provided on DVD's. They are Flexor tendon repair: early active motion protocol Flexor tendon repair: passive protocol Flexor Pollicis Longus (FPL) repair: early active motion protocol Flexor Pollicis Longus (FPL) repair: passive protocol Short arc early active range of motion repair for zones 2 to 3 Controlled early active motion for zones four to seven extensor tendon repair TriMed wrist fixation system (TriMed Inc, Valencia, CA, U.S.A.) following Distal radius Fracture. The protocols have been published by EKCO Occupational Services Hand and Upper Limb Rehabilitation Unit in Brisbane Following initial appointment with the Occupational Therapist, if a patient is to begin one of the seven protocols they are invited to participate in the study. At the initial appointment all patients are provided with their usual care that includes splinting, wound and oedema management and the implementation of exercise therapy protocols. They are all provided with brochures and sent to an administration officer who randomly assigns them to a DVD or no DVD group. Length of time for initial appointment is 30 minutes to one hour. Patients return for weekly appointments, which are an average 30 minutes duration, where exercises are checked for correctness and understanding, wound management and oedema management continues and splints modified if necessary. Patients are then advised to move to the next weekly stage on the DVD if they have been provided with one, and all are provided with a brochure entailing upgraded exercises. The duration of each weekly stage for both the brochure and DVD is 7 days. The weekly upgrading of exercises for the protocols on both the DVD and brochure covers a six week period. Hand therapy treatment for scar management and ongoing range of movement and oedema management can extend beyond this and is dependent on the clinical status of the patient.
Intervention code [1] 3402 0
Rehabilitation
Comparator / control treatment
Brochures/handouts are provided to all patients at the initial appointment as part of standard treatment.Length of time for initial appointment is 30 minutes to one hour. They are provided each week as exercises are upgraded. Subsequent weekly appointments are for an average of 30 minutes. The brochures are static illustrations of same protocols as demonstrated on the DVD. The brochures contain step by step instructions regarding exercises and precautions following surgery. Each protocol has a series of up to seven brochures, which relate to the upgrading of exercises each week Patients in the control group receive weekly appointments, which is part of standard treatment
Control group
Active

Outcomes
Primary outcome [1] 4756 0
Survey designed specifically for the study to measure compliance with the home exercise program
Timepoint [1] 4756 0
At six weeks after initial hand therapy appointment ( patient commences protocol) and patient consent to participate in trial
Secondary outcome [1] 8034 0
Checklist designed specifically for the study to measure correctness and understanding of exercises
Timepoint [1] 8034 0
At six weeks after therapy intervention

Eligibility
Key inclusion criteria
Receiving hand therapy using protocols for one of the following diagnosis: distal radius fracture using a TriMed wrist fixation system (TriMed Inc, Valencia, CA, U.S.A.) following Distal radius Fracture., flexor tendon repairs, Flexor Pollicis Longus (FPL) repairs, extensor tendon repairs in zones 3-7
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under the age of 18
Does not have a DVD player
unable to attend weekly hand therapy treatment sessions

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)
Therapists at the treatment facility determine eligibility of patient to participate in the study and then refer patient to the holder of the allocation schedule who was in a separate office
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by researcher using computer software indicate which group each participant will be assigned to as they present to the holder of the allocation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3870 0
Government body
Name [1] 3870 0
Primary Health Care Research Evaluation and Development
Country [1] 3870 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
School of Rehabilitation Sciences
Department of Occupational Therapy
101 Angus Smith Drive
Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 3474 0
Individual
Name [1] 3474 0
Marion Gray
Address [1] 3474 0
School of Rehabilitation Sciences
Department of Occupational Therapy
James Cook University
101 Angus Smith Drive
Townsville QLD 4817
Country [1] 3474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5923 0
Townsville Health Service District Health and Research Ethics Committee
Ethics committee address [1] 5923 0
The Townsville Hospital
PO Box 670
Townsville QLD 4810
Ethics committee country [1] 5923 0
Australia
Date submitted for ethics approval [1] 5923 0
Approval date [1] 5923 0
14/05/2007
Ethics approval number [1] 5923 0
14/07
Ethics committee name [2] 5924 0
James Cook University Ethics Committee
Ethics committee address [2] 5924 0
James Cook University
101 Angus Smith Drive
Townsville QLD 4811
Ethics committee country [2] 5924 0
Date submitted for ethics approval [2] 5924 0
Approval date [2] 5924 0
05/07/2007
Ethics approval number [2] 5924 0
H2697

Summary
Brief summary
This study seeks to determine if compliance and understanding of a home exercise program is improved when the patients are provided with a DVD and a brochure when compared to using brochures only. This is particularly relevant for rural and remote residents who may not be able to attend weekly therapy sessions at the hospital
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28931 0
Address 28931 0
Country 28931 0
Phone 28931 0
Fax 28931 0
Email 28931 0
Contact person for public queries
Name 12088 0
Gail Kingston
Address 12088 0
Occupational Therapy Department
School of Rehabilitation Sciences
James Cook University
101 Angus Smith Drive
Townsville QLD 4811
Country 12088 0
Australia
Phone 12088 0
07 4781 4818
Fax 12088 0
Email 12088 0
[email protected]
Contact person for scientific queries
Name 3016 0
Dr Marion Gray
Address 3016 0
School Of Rehabilitation Sciences
Department of Occupational Therapy
James Cook University
101 Angus Smith Drive
Townsville QLD 4811
Country 3016 0
Australia
Phone 3016 0
07 4781 5951
Fax 3016 0
Email 3016 0
[email protected]

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
No additional documents have been identified.