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Trial registered on ANZCTR


Registration number
ACTRN12624000597594
Ethics application status
Approved
Date submitted
8/02/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A streamlined approach to identifying adults suited to neck rehabilitation following concussion: a feasibility study.
Scientific title
A streamlined approach to identifying adults suited to orthopedic musculoskeletal physiotherapy management acutely following concussion: a feasibility study.
Secondary ID [1] 311500 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 332830 0
mild Traumatic Brain Injury 332831 0
Condition category
Condition code
Neurological 329548 329548 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 329948 329948 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals will be screened by a musculoskeletal physiotherapist specialising in clinical management of concussion for clinical indicators inferring referal for orthopedic musculoskeletal physiotherapy management (of the cervical spine) acutely following concussion is indicated. Screening procedures are based on clinical diagnostic rules used for musculoskeletal disorders of the neck. Published clinical diagnositic rules for identification of neck disorders require evidence of a combination of physical signs of neck impairment including but not limited to, positive findings on manual examination and or palpatino of the neck, limitations in available active range of neck motion, and or impaired neuromusclular performance. Best practice guidelines for concussion management (See Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport–Amsterdam, October 2022 and Targeted interventions and their effect on recovery in children, adolescents and adults who have sustained a sport-related concussion: a systematic review; published 2023) support multidimensional assessment and management of the neck and sensorimotor (specifically vestibulo occular) systems, where identification of impairment post-injury is identified. Hence development of the physical screen is based on this and treatment will be patient centred, pragmatic in nature, and in accord with current best practice guidelines. .
Once screened and identified as appropriate for neck rehabilitation, participants will be offered four weeks of treatment with a musculoskeletal phyisotherapists. A maximum of 2 one on one treatment sessions will be available each week. Treatment sessions will be of 30 minutes duration with exception of the first treatment session where participants will complete the Buffalo Concussion Treadmill Test to identify maximal heart rate levels for daily acitivity, in accord with best pactice guidelines for concussion management. Determination of treatment frequency will be made by the treating physiotherapist, in accord with a pragmatic intervention approach. Participants will be required to complete a daily record of compliance with their home exercise program for the duration of their treatment. Exercise which will be prescribed includes a daily walking regime at a target heart rate, based on best practice guidelines. Examples of exercises specific to cervical spine which may be included in participant home exercise programs include: range of motion, proprioceptive or neuromuscular exercises. Participants may be discharged before completion of the four weeks of treatment at the discretion of the treating physiotherapist in accord with a pragmatic treatment approach. The treating physiotherapist will record any missed treatment sessions. The main aim of the study is to determine feasibility of the study design rather than explicit treatment effect.
Intervention code [1] 327948 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337343 0
Health care provider perception of screening process;
Timepoint [1] 337343 0
Health care provider - interview and focus groups held on discharge of final participant receiving 4 weeks of neck rehabilitation.
Primary outcome [2] 337706 0
Concussed participant compliance, satisfaction, adverse events and adherence to the intervention will be measured independently but considered as a single outcome, Please see below for reporting as individual secondary outcomes.
Timepoint [2] 337706 0
Participant satisfaction, and adherence to the intervention (compliance with the home exercise program) will be collected from the participant at the 5 week follow up (1 week following conclusion of 4 week treatment period or per protocol if pragmatic treatment period is < the full 4 weeks). The appointment attendance record as well as record of the number of any adverse events will be collected from the treating clinician at the end of the 4 week treatment period (or per protocol).
Secondary outcome [1] 431514 0
Overall eligibility for neck rehabilitation (yes/ no)
Timepoint [1] 431514 0
1 week follow up post completion of 4 week treatment period (or per protocol if treatment finished early). 3 month follow up post completion of 4 week treatment period (or per protocol if treatment finished early).
Secondary outcome [2] 434170 0
Participant satisfaction.
Timepoint [2] 434170 0
5 week follow up (1 week following conclusion of 4 week treatment period or per protocol if pragmatic treatment period is < the full 4 weeks).
Secondary outcome [3] 434171 0
Participant compliance.
Timepoint [3] 434171 0
Collected from the treating physiotherapist at the end of the 4 week treatment period (or per protocol)
Secondary outcome [4] 434172 0
Adverse reactions such as significant increase in symptoms in direct response to the initial screening or treatment. These may include increased neck pain, increased dizziness possibly resulting in vomitting (not as an indicator of possible intracranial bleeding, but in response to sensory stimulation), increased difficulty with concentration.
Timepoint [4] 434172 0
Adverse reactions will be recorded by clinicians in patient treatment notes, per occurrence. Overall number of adverse reactions for each patient will be collected from the treating physiotherapist at the end of the 4 week treatment period (or per protocol)
Secondary outcome [5] 434173 0
Participant adherence to the intervention.
Timepoint [5] 434173 0
5 week follow up (1 week following conclusion of 4 week treatment period or per protocol if pragmatic treatment period is < the full 4 weeks).

Eligibility
Key inclusion criteria
medically diagnosed concussion/ mild traumatic brain injury
not > 14 days since injury
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Moderate to severe TBI as defined by published diagnostic criteria
• Diagnosed concussion with associated trauma related abnormalities apparent on CT or MRI and/ or cervical spine fracture
• Diagnosed concussion due to assault
• Neck pain unrelated to concussion injury(/ies) (requiring treatment)
• Headache disorders (including cervicogenic, migraine (chronic), and tensions type headaches)
• Vestibular, oculomotor, neurological disorders
• Major psychiatric disorders currently being actively treated
• Physical injury that would prevent completion of the screening session

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size: Based on previously identified rates of neck impairment post-concussion, it is anticipated that screening of 160 participants will be required to identify 60 individuals who meet inclusion criteria. Allowing for 50% of individuals to decline participation in the trial and a 10% drop-out rate, it is anticipated that data from n=27 participants (treatment commenced with n=30) will be collected at all data collection time points. This group size is consistent with those currently used in randomised control trials investigating outcome following OMT of the neck post-concussion and with recommendations regarding pilot data sample sizes so is considered adequate for this feasibility study.
Statistical methods/ analysis plan: We will use Thematic Analysis, an evaluative deductive approach to analyse the qualitative focus group and interview data of health care provider participants. The programme will be considered feasible if 80% of patients complete the programme until either formal discharge or the end of the 4 weeks of treatment based on the physiotherapists’ assessment and treatment documentation. Adherence will be considered acceptable if 80% of exercises had been recorded in the patient’s logbooks. Patient satisfaction score (/12) from the patient satisfaction exiting questionnaire will be calculated and mean and 95% CI will be reported. Triangulation of qualitative (analysis described above) and quantitative outcomes will determine overall feasibility of using the SPE to inform treatment management.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/10/2023
Date of last participant enrolment
Anticipated
25/10/2024
Actual
Date of last data collection
Anticipated
14/02/2025
Actual
Sample size
Target
30
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 26139 0
New Zealand
State/province [1] 26139 0
Otago

Funding & Sponsors
Funding source category [1] 315790 0
Charities/Societies/Foundations
Name [1] 315790 0
Stanley Paris Fellowship Award
Country [1] 315790 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 317917 0
None
Name [1] 317917 0
Address [1] 317917 0
Country [1] 317917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314648 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 314648 0
Ethics committee country [1] 314648 0
New Zealand
Date submitted for ethics approval [1] 314648 0
13/02/2023
Approval date [1] 314648 0
14/03/2023
Ethics approval number [1] 314648 0
H23/022

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

Contacts
Principal investigator
Name 132274 0
Dr Olivia Galea
Address 132274 0
School of Physiotherapy, University of Otago, 325 Great King St, Dunedin, Otago. 9016
Country 132274 0
New Zealand
Phone 132274 0
+642102840717
Fax 132274 0
Email 132274 0
olivia.galea@otago.ac.nz
Contact person for public queries
Name 132275 0
Olivia Galea
Address 132275 0
School of Physiotherapy, University of Otago, 325 Great King St, Dunedin, Otago. 9016
Country 132275 0
New Zealand
Phone 132275 0
+642102840717
Fax 132275 0
Email 132275 0
olivia.galea@otago.ac.nz
Contact person for scientific queries
Name 132276 0
Olivia Galea
Address 132276 0
School of Physiotherapy, University of Otago, 325 Great King St, Dunedin, Otago. 9016
Country 132276 0
New Zealand
Phone 132276 0
+642102840717
Fax 132276 0
Email 132276 0
olivia.galea@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21593Study protocol  olivia.galea@otago.ac.nz 387304-(Uploaded-08-02-2024-14-29-50)-Study-related document.pdf
21594Informed consent form  olivia.galea@otago.ac.nz This consent form is for health care provider part... [More Details] 387304-(Uploaded-08-02-2024-14-32-18)-Study-related document.pdf
21595Informed consent form  olivia.galea@otago.ac.nz This consent form is for concussed participants. 387304-(Uploaded-08-02-2024-14-31-21)-Study-related document.pdf



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.