Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000414617
Ethics application status
Approved
Date submitted
31/03/2023
Date registered
26/04/2023
Date last updated
21/04/2024
Date data sharing statement initially provided
26/04/2023
Date results information initially provided
21/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a novel gait training technology on physical health and mobility.
Scientific title
The effect of a novel gait training technology on physical health and mobility of adults with mobility impairments.
Secondary ID [1] 309366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 329581 0
Spinal Cord Injury 329582 0
Lower Limb Amputation 329583 0
Condition category
Condition code
Neurological 326502 326502 0 0
Other neurological disorders
Injuries and Accidents 326503 326503 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 326504 326504 0 0
Physiotherapy
Musculoskeletal 326505 326505 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Body weight support treadmill training, 10 sessions (two sessions per week, 5 week duration, adherence monitoried at each session), 60 minutes per session. Sessions will be conducted by physiotherapists in one-on-one sessions. This technology includes mechanical assistance to facilitate limb movement (hip/knee flexion/extension), augmented reality (walking through a forest), visual feedback (for foot placement). Speed and body weight support will be set to individual appropriate levels as determined by the therapist. Minimum 5 week wash out between arms of the study.
Intervention code [1] 325798 0
Rehabilitation
Comparator / control treatment
Usual care defined as the patient continuing their usual rehabilitation therapies external to the program. This control period is for 5 weeks
Control group
Active

Outcomes
Primary outcome [1] 334351 0
Feasibility determined against the below criteria
­1. Recruitment rates and willingness to participate (determined from recruitment log)
­2. Adherence to the treatment protocol (number of treatment sessions and average duration of each session). Will be determined agains attendance log.
­3. Acceptability and perceived helpfulness will be assessed on a 5-point Likert scales

Protocol will be considered feasible if >80% of potential participants are recruited, adherence >90% and program is considered acceptable/helpful, scoring at least 4/5 of the likert scales.
Timepoint [1] 334351 0
End of intervention
Secondary outcome [1] 420343 0
Safety
­Adverse events will be monitored and reported.
­A falls diary will be provided for the duration of the study, with participants documenting frequency and nature of any falls experienced.
Timepoint [1] 420343 0
End of intervention
Secondary outcome [2] 420344 0
Functional Ambulation Category
Timepoint [2] 420344 0
Pre intervention (within one day of beginning intervention), post intervention (within one day of completing intervention), pre control (within one day of beginning control), post control (within one day of completing control)
Secondary outcome [3] 420345 0
Quality of life (EQ5D)
Timepoint [3] 420345 0
Pre intervention (within one day of beginning intervention), post intervention (within one day of completing intervention), pre control (within one day of beginning control), post control (within one day of completing control)
Secondary outcome [4] 420346 0
Gait speed (for participants who can mobilise) using a GaitRite instrumented walkway.
Timepoint [4] 420346 0
Pre intervention (within one day of beginning intervention), post intervention (within one day of completing intervention), pre control (within one day of beginning control), post control (within one day of completing control)

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they are aged >18 years and have mobility impairments (defined as functional ambulation category of 0-4) following lower-limb amputation, brain or spinal cord injury.

Specific inclusion criteria for lower-limb amputees and people with spinal cord injury are: Amputees will be required to have a prosthesis (K-level 1 or 2, indicating a limited household, or limited community ambulator), people with spinal cord injury will be required to have an incomplete spinal cord injury and categorised as ASIA impairment scale C or D (i.e. some motor function preserved below the neurological level).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for all participants will be inability to follow two-step commands, travel to the treatment site, or pre-existing mobility impairments that are unrelated to the amputation, brain or spinal cord injury.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We will conduct a 2 GROUP (intervention, control) x 2 TIME-POINT (baseline, post treatment) linear mixed model for each outcome measure (physical activity, functional ambulation category, quality of life, gait speed). Where appropriate, post-hoc analysis with Bonferroni correction will be performed. Adverse events and falls diary data will be descriptively reported. Feasibility measures (recruitment rates, acceptability, perceived helpfulness, completed sessions and average duration) will be descriptively reported. In addition, acceptability and perceived helpfulness Likert scale scores, and both number and duration of sessions will be analysed with a 2 GROUP (intervention, control) x 3 CONDITION (lower-limb amputee, traumatic brain injury, spinal cord injury) linear mixed model. Qualitative interviews will be analysed and reported using thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2022
Date of last participant enrolment
Anticipated
31/07/2023
Actual
29/09/2023
Date of last data collection
Anticipated
10/11/2023
Actual
20/12/2023
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24452 0
UniSA Health and Medical Clinic (City West) - Adelaide
Recruitment postcode(s) [1] 40034 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313564 0
University
Name [1] 313564 0
University of South Australia
Country [1] 313564 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 315344 0
None
Name [1] 315344 0
Address [1] 315344 0
Country [1] 315344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312743 0
University of South Australia’s Human Research Ethics Committee
Ethics committee address [1] 312743 0
108 North Terrace, Adelaide, South Australia 5001
Ethics committee country [1] 312743 0
Australia
Date submitted for ethics approval [1] 312743 0
Approval date [1] 312743 0
30/03/2022
Ethics approval number [1] 312743 0

Summary
Brief summary
We will conduct a pilot cross-over randomised controlled trial to assess feasibility of delivering mobility training using a gait rehabilitation technology. Upon enrolment, participants will be randomly allocated to the intervention or control group (1:1 ratio), before crossing over to the other arm of the trial. All treatments will be provided at the University of South Australia (UniSA) Health and Medical Clinic through a student led service, supervised by qualified clinicians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125750 0
Dr Brenton Hordacre
Address 125750 0
University of South Australia, 108 North Terrace, Adelaide, South Australia 5001
Country 125750 0
Australia
Phone 125750 0
+61 8 830 21286
Fax 125750 0
Email 125750 0
brenton.hordacre@unisa.edu.au
Contact person for public queries
Name 125751 0
Dr Brenton Hordacre
Address 125751 0
University of South Australia, 108 North Terrace, Adelaide, South Australia 5001
Country 125751 0
Australia
Phone 125751 0
+61 8 830 21286
Fax 125751 0
Email 125751 0
brenton.hordacre@unisa.edu.au
Contact person for scientific queries
Name 125752 0
Dr Brenton Hordacre
Address 125752 0
University of South Australia, 108 North Terrace, Adelaide, South Australia 5001
Country 125752 0
Australia
Phone 125752 0
+61 8 830 21286
Fax 125752 0
Email 125752 0
brenton.hordacre@unisa.edu.au

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?

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.