Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001565134
Ethics application status
Approved
Date submitted
13/09/2019
Date registered
13/11/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Swelling in the hand in people with tetraplegia: exploring the experience and two treatment approaches
Scientific title
Oedema in the hand in people with tetraplegia: exploring the experience and two treatment approaches
Secondary ID [1] 299188 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 314286 0
oedema in the hands 314287 0
Condition category
Condition code
Neurological 312637 312637 0 0
Other neurological disorders
Cardiovascular 313254 313254 0 0
Diseases of the vasculature and circulation including the lymphatic system
Injuries and Accidents 313409 313409 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two treatment methods will be applied to the hands of people with tetraplegia who present with oedema. The treatment methods are compression bandaging and the boxing glove splint for a period of 10-11 days.
The intervention will be applied by the treating Occupational Therapist. The participant and the therapists will all be told prior to commencement of the study that the intervention period is 10-11 days. It follows a ABA case design.
Phase A: The researcher will complete the assessments daily for 3 consecutive days , no intervention.
Phase B: the hands will receive either of the interventions dependent on pre-determined allocation. This will occur over 10-11 days, with assessment completed every 3-4 days. This will commence immediately following the assessment on the 3rd day.
Phase A: This will commence the the day after the final day of assessment in phase B. 3 consecutive days of assessments, with no intervention.
This will all be initiated and monitored by the researcher.
Assessment and monitoring of adherence will be completed by the treating therapist as they are treating the patient on a daily basis. The boxing glove splint will be applied by the nursing staff and this will be documented in their medical records as per standard practice. The monitoring of adherence for the coban bandaging will also be reported by the occupational therapist and removal of this due to circumstances will be documented in the medical records as per standard practice.
There is a pre-determined allocation system. Only one intervention will be applied to one hand during this study.

Unilateral oedema allocation
1. The Boxing Glove splint
2. Coban™
3. The Boxing Glove splint
4. Coban™
5. The Boxing Glove splint
6. Coban™
7. The Boxing Glove splint
8. Coban™

Bilateral oedema allocation
1. Left: The Boxing Glove splint Right: Coban™
2. Left: Coban™ Right: The Boxing Glove splint
3. Left: The Boxing Glove splint Right: Coban™
4. Left: Coban™ Right: The Boxing Glove splint

Semi structured interviews will be conducted with the participants following the intervention
Intervention code [1] 315482 0
Treatment: Other
Comparator / control treatment

The impact of no intervention compared to the impact of intervention.
The impact of compression bandaging compared to boxing glove splint Compression bandaging is the comparator

This study is not a randomized control study
Control group
Active

Outcomes
Primary outcome [1] 321291 0
Effect (change of oedema) of treatment vs no treatment
This is assessed by using the tape measure to gain the circumferential measurement to detect changes to oedema. It will be assessed daily during the initial phase A, 3 consecutive days of no intervention.
This will then be followed by 10-11 days of intervention, where the tape measure will be used for assessments every 3-4 days i.e. 3 times during this phase.
Finally, there will be a repeat of the initial phase, 3 consecutive days of of no intervention.

Timepoint [1] 321291 0
Phase A: 3 consecutive days of assessment at the same time - no intervention during this phase
Phase B: assessment at the same time as phase A, every 3-4 days for 10-11days
Phase A; 3 consecutive days of assessment at the same time - no intervention during this phase.
Primary outcome [2] 321670 0
Effect (change of oedema) of boxing glove splint vs compression bandaging
This is assessed by using the tape measure to gain the circumferential measurement to detect changes to oedema.
Timepoint [2] 321670 0
Every 3-4 days during Phase B (intervention phase). This will occur a total of 3 times during this phase.
Secondary outcome [1] 375846 0
This is a composite.
Experience of oedema and oedema management for a person with tetraplegia. Semi structured interviews will be conducted with each participant by the researcher immediately following the quantitative study.
Timepoint [1] 375846 0
This will be completed immediately following the last day of assessment (second Phase A)

Eligibility
Key inclusion criteria
• a newly cervical spinal cord injury resulting in tetraplegia.
• oedema in one or both hands
• currently receiving rehabilitation and will remain an inpatient for the duration of the study
• adequate English, cognitive and communication skills to participate in the semi-structured interview
• aged over 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• history of lymphoedema, mastectomy and /or any other conditions that may have caused oedema in the upper limbs
• peripheral oedema that may indicate compression as an contraindication and is managed with diuretics
• history of cerebrovascular disease
• recent trauma or orthopaedic complications to the hands and/or wrist
• unable to participate in the treatment for temporary reasons i.e. cannula in situ at the site of treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The quantitative study will have raw data plotted on a graph for visual analysis using level, trend and variability within the experimental phase. The visual presentation of the grapshed raw data and a narrative description of the visual analysis will be reported to provide a clear picture of the information collected during the study.
The qualitative study will be analysed using interpretive descriptive approach. The raw data will be coded and themed for analysis and described thematically.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14721 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 27761 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303727 0
University
Name [1] 303727 0
Griffith University
Country [1] 303727 0
Australia
Primary sponsor type
Individual
Name
Soo Oh
Address
c/o Occupational Therapy dept
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 304222 0
University
Name [1] 304222 0
Griffith University
Address [1] 304222 0
Nathan Campus
Kessels Rd
Nathan, QLD 4111
Country [1] 304222 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304252 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 304252 0
Ethics committee country [1] 304252 0
Australia
Date submitted for ethics approval [1] 304252 0
17/07/2019
Approval date [1] 304252 0
21/08/2019
Ethics approval number [1] 304252 0
HREC/2019/QMS/55164

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

Contacts
Principal investigator
Name 96294 0
Ms Soo Oh
Address 96294 0
c/o Occupational Therapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 96294 0
Australia
Phone 96294 0
+61 401390359
Fax 96294 0
Email 96294 0
[email protected]
Contact person for public queries
Name 96295 0
Soo Oh
Address 96295 0
c/o Occupational Therapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 96295 0
Australia
Phone 96295 0
+61 401390359
Fax 96295 0
Email 96295 0
[email protected]
Contact person for scientific queries
Name 96296 0
Soo Oh
Address 96296 0
c/o Occupational Therapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, QLD 4102
Country 96296 0
Australia
Phone 96296 0
+61 401390359
Fax 96296 0
Email 96296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual participant data will only be available to the individual participant and will not be available for analysis by anyone outside of the research team


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.