Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000720415
Ethics application status
Approved
Date submitted
10/06/2025
Date registered
7/07/2025
Date last updated
7/07/2025
Date data sharing statement initially provided
7/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Immersion Therapy delivered by an Accredited Exercise Physiologist on physical and psychosocial recovery following traumatic injury when transitioning from hospital inpatient to outpatient care
Scientific title
Effect of Immersion Therapy delivered by an Accredited Exercise Physiologist on physical and psychosocial recovery when transitioning from hospital inpatient to outpatient care in adults that have experienced a traumatic neurological injury including brain, spinal, and lower limbs.
Secondary ID [1] 314606 0
None
Universal Trial Number (UTN)
Trial acronym
D2 LSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic neurological (spinal, brain, or proximal limb) injury 337741 0
Condition category
Condition code
Physical Medicine / Rehabilitation 334065 334065 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 334300 334300 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study proposes to use a mixed model design including a randomised controlled trial (RCT) design for both quantitative and qualitative (self-report) outcomes and then to conduct qualitative semi-structured interviews with a representative sub-group of participants.

The RCT will use a wait-list control whereby participants are randomised to receive 16 weeks of IT immediately upon enrolment or after a 16 week wait. Outcome measures will be assessed at weeks 0, 16 and 32 allowing the RCT comparison as well as a non-randomised crossover analysis (in wait-listed participants) and a single group prospective 16 week follow up (in intervention group).

The intervention will be the standard Immersion Therapy (IT) service model delivered by accredited IT Specialists (who are also Accredited Exercise Physiologists). IT is an underwater experience for people living with injury, chronic illness and/or disability, TBI, SCI, as well as chronic pain, mental illness, and developmental and degenerative disorders. Using scuba equipment (a buoyancy control device and regulator or full-face mask) in a two-to-five-metre deep pool environment, clients can swim, walk, play or relax, completely immersed. IT does not aim to teach clients to dive recreationally but utilizes scuba as a form of ‘therapy’, aiming to exert its effects, either through physical movement underwater and/or the psychosocial experience.

Participants will be introduced to the service at their own pace in accordance with existing protocols and given complete independence in designing their service in collaboration with their clinician.

The treating clinicians will liaise with other service providers as appropriate to ensure the service can complement the person’s rehabilitation goals. Participants will be asked to attend at least 1 and up to 2 session per week for 16 weeks with each session lasting up to 45 minutes. Sessions will be conducted in a one-on-one format, with participant attendance recorded through the service provider’s (Determined2) existing booking system. Attendance will be monitored weekly by the service provider’s Operations Manager to ensure adherence.

The IT will take place at The Parks Recreation & Sports Centre, 46 Cowan Street, Angle Park, SA.

Semi-structured, one-on-one interviews will be conducted by a member of research team either face-to-face or via video conferencing and at take 45 to 60 minutes.

All participants that have completed the IT program will be invited to participate in the interviews until the sample size is sufficient that novel data become so infrequent that further interviews are unlikely to meaningfully alter the results.

Interviews will be audio recorded with participant consent and transcribed using a professional transcription service.
Intervention code [1] 331235 0
Treatment: Other
Comparator / control treatment
The control group will be a ‘wait-list control’ meaning they will not receive access to IT for the 16-week intervention period but will then be given access to the service for the following 16 weeks. This allows for a crossover comparison in this group which, although will not be randomised, will add strength to the comparison of the intervention to control period on outcomes.
Control group
Active

Outcomes
Primary outcome [1] 341730 0
Physical function - this will be assessed as a composite outcome that includes the methods listed below.
Timepoint [1] 341730 0
Baseline, 16 and 32 weeks post-commencement of intervention
Primary outcome [2] 341731 0
Mental Health and Wellbeing - this will be assessed as a composite outcome that includes the methods listed below.
Timepoint [2] 341731 0
Baseline, 16 and 32 weeks post-commencement of intervention
Primary outcome [3] 341733 0
Quality of life - this will be assessed as a composite outcome that includes the methods listed below.
Timepoint [3] 341733 0
Baseline, 16 and 32 weeks post-commencement of intervention
Secondary outcome [1] 448544 0
Pain - this will be assessed as a composite outcome that includes the methods listed below.
Timepoint [1] 448544 0
Baseline, 16 and 32 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Are between 18 and 65 years old.
Have experienced a traumatic injury resulting in permanent impairment to neurological function (brain, spinal cord or upper/lower limb).
Are within 12 months of discharge from inpatient rehabilitation.
Understand spoken and written English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not pass the IT Medical Exam.
Not able to attend one session of IT each week for 16 weeks
Are participating in non-standard (as determined by research team senior clinicians) treatment or activities that significantly overlap with IT (ie significant additional physical activity/exercise or water-based treatment).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The RCT will use a wait-list control whereby participants are randomised to receive 16 weeks of IT immediately upon enrolment or after a 16 week wait.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28028 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 44231 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 319165 0
Government body
Name [1] 319165 0
Lifetime Support Authority of South Australia
Country [1] 319165 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321623 0
Government body
Name [1] 321623 0
SA Health
Address [1] 321623 0
Country [1] 321623 0
Australia
Other collaborator category [1] 283541 0
Commercial sector/Industry
Name [1] 283541 0
Determined 2
Address [1] 283541 0
Country [1] 283541 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317745 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317745 0
Ethics committee country [1] 317745 0
Australia
Date submitted for ethics approval [1] 317745 0
19/09/2023
Approval date [1] 317745 0
26/09/2023
Ethics approval number [1] 317745 0
2022/HRE00296
Ethics committee name [2] 317750 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 317750 0
Ethics committee country [2] 317750 0
Australia
Date submitted for ethics approval [2] 317750 0
Approval date [2] 317750 0
06/11/2023
Ethics approval number [2] 317750 0
205930

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

Contacts
Principal investigator
Name 142014 0
A/Prof Kade Davison
Address 142014 0
Allied Health and Human Performance, University of South Australia, City East Campus, Centenary Building c8-51, North Terrace, Adelaide SA 5000, Australia
Country 142014 0
Australia
Phone 142014 0
+61 8 8302 1152
Fax 142014 0
Email 142014 0
[email protected]
Contact person for public queries
Name 142015 0
Anthony Mezzini
Address 142015 0
Allied Health and Human Performance, University of South Australia, City East Campus, Playford Building P5-41, North Terrace, Adelaide SA 5000, Australia
Country 142015 0
Australia
Phone 142015 0
+61 427 820 256
Fax 142015 0
Email 142015 0
[email protected]
Contact person for scientific queries
Name 142016 0
Anthony Mezzini
Address 142016 0
Allied Health and Human Performance, University of South Australia, City East Campus, Playford Building P5-41, North Terrace, Adelaide SA 5000, Australia
Country 142016 0
Australia
Phone 142016 0
+61 427 820 256
Fax 142016 0
Email 142016 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.