Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000433404
Ethics application status
Approved
Date submitted
7/02/2025
Date registered
9/05/2025
Date last updated
9/05/2025
Date data sharing statement initially provided
9/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate Pre-Post Effects of the Lightback Device on posterior chain Flexibility and Sciatic Nerve Stiffness in Healthy Adults.
Scientific title
A Pre-Post Interventional Study Evaluating the Immediate Effects of the Lightback Device on Active Knee Extension, Active Straight Leg Raise, and Shear Wave Elastography Measurements of the Sciatic Nerve and Proximal Hamstring Tendon in Healthy Adults.
Secondary ID [1] 313918 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decreased posterior chain flexibility 336608 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333114 333114 0 0
Physiotherapy
Musculoskeletal 333115 333115 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One physiotherapist conducts one-on-one sessions with the patient, gradually increasing stretching until the patient reaches the maximum sensation without pain. Each stretching session lasts for 5 minutes Checklists were employed to assess patient interventions.

Experimental Group:
The LightBack® machine involves an anterior-posterior (A-P) mobilization of the femur, inducing a stretch of the posterior hip capsule and gluteal muscles. The subject will sit on the machine, bringing the knee towards the chest until it reaches 90º of hip flexion. When the subject feels a stretching sensation without pain, they will hold the position for 10 seconds. Subsequently, they will return to the initial relaxed position for 5 seconds and repeat the sequence 6 times for a total application time of one minute. It's a self-passive mobilization.

The wash-out period between treatments will be 48 hours, which is considered sufficient to avoid carry-over effects in neuromuscular adaptations and perceived flexibility following a single stretching session. This interval is based on previous studies showing that the acute effects of stretching or posterior hip mobilization typically return to baseline within 24 to 48 hours. No stretching or physical therapy will be performed during this interval.

Participants will be instructed to refrain from engaging in lower limb exercise or stretching during the wash-out period to ensure consistency.
Intervention code [1] 330508 0
Prevention
Intervention code [2] 330509 0
Rehabilitation
Comparator / control treatment
Participants assigned to the control group will remain in a supine position for 10 minutes, matching the duration of the intervention group.
No manual therapy, mobilization, or stretching techniques will be applied.
Participants will be instructed not to perform any voluntary movements or compensatory postures during this period.
They will be allowed to breathe normally but must avoid engaging in activities such as tensing their muscles or adjusting their posture voluntarily.
Control group
Active

Outcomes
Primary outcome [1] 340656 0
Active Knee Extension Test (AKE)
Timepoint [1] 340656 0
Baseline and Immediately after the treatment
Primary outcome [2] 340657 0
Active Straight Leg Raise (ASLR)
Timepoint [2] 340657 0
Baseline and Immediately after the treatment
Secondary outcome [1] 444715 0
shear wave elastography (SWE) measurements of the sciatic nerve
Timepoint [1] 444715 0
immediately before and after the intervention
Secondary outcome [2] 444716 0
Change in shear wave elastography (SWE) measurements of the proximal hamstring tendon
Timepoint [2] 444716 0
immediately before and after the intervention

Eligibility
Key inclusion criteria
Healthy adults aged 18-40 years.
No history of lower back or hip pain in the past 6 months.
No prior lower limb surgery.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Exclusion criteria were individuals with a history of musculoskeletal lower limb or lumbopelvic conditions within the last five years, as well as those with neuromuscular, rheumatic, cardiovascular or neurological diseases, and those who had undergone previous surgical interventions or experienced fractures in the lower extremities or abdominal region.
- To be pregnant
- Allergic to a material in the machine
- To experience any type of pain during the procedure

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Simple randomisation using a randomisation table created by computer software. Allocation concealment will be ensured by using sealed, opaque, sequentially numbered envelopes prepared by a third party not involved in participant recruitment or assessment. Each envelope will contain the group assignment based on the randomisation list, and will be opened only after the participant has been enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated using simple randomisation (1:1 allocation ratio) through a computer-generated random number table created in Excel. No restrictions or blocking will be applied.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis was carried out using IBM SPSS Statistics version 29.0 software for Windows (IBM, Armonk, NY, USA). To assess data distribution, the Kolmogorov-Smirnov test and histogram examination were employed. For parametric variables (p > 0.05), descriptive statistics including mean and standard deviation were presented, while for non-parametric variables (p < 0.05), median and interquartile range were reported.
To compare the baseline characteristics of the two groups, either an independent t-test or Mann-Whitney U test was performed, taking into account assumptions of homoskedasticity and sphericity. If these assumptions were met, a two-way analysis of variance (ANOVA) with a 2 × 2 design was conducted. The effect size was assessed using partial eta squared (n2p), with values of 0.01 interpreted as small, 0.06 as medium, and 0.14 as large. A 95% confidence interval was set to all analyses. Correlation Analysis: Pearson correlation coefficient to assess relationships between changes in flexibility and SWE parameters.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
26/06/2025
Actual
Date of last data collection
Anticipated
26/06/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26873 0
Spain
State/province [1] 26873 0
Madrid

Funding & Sponsors
Funding source category [1] 318391 0
Self funded/Unfunded
Name [1] 318391 0
Country [1] 318391 0
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 320793 0
None
Name [1] 320793 0
Address [1] 320793 0
Country [1] 320793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317025 0
Comisión de Investigación de la Universidad Europea de Madrid
Ethics committee address [1] 317025 0
Ethics committee country [1] 317025 0
Spain
Date submitted for ethics approval [1] 317025 0
03/02/2025
Approval date [1] 317025 0
02/04/2025
Ethics approval number [1] 317025 0
2025-399

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

Contacts
Principal investigator
Name 139770 0
Dr Ángel González de la Flor
Address 139770 0
Universidad Europea de Madrid– Facultad de Medicina, Salud y Deporte. Calle Tajo, s/n Urb. El Bosque. 28670, Villaviciosa de Odón, Madrid,
Country 139770 0
Spain
Phone 139770 0
+34667427424
Fax 139770 0
Email 139770 0
[email protected]
Contact person for public queries
Name 139771 0
Ángel González de la Flor
Address 139771 0
Universidad Europea de Madrid– Facultad de Medicina, Salud y Deporte. Calle Tajo, s/n Urb. El Bosque. 28670, Villaviciosa de Odón, Madrid,
Country 139771 0
Spain
Phone 139771 0
+34667427424
Fax 139771 0
Email 139771 0
[email protected]
Contact person for scientific queries
Name 139772 0
Ángel González de la Flor
Address 139772 0
Universidad Europea de Madrid– Facultad de Medicina, Salud y Deporte. Calle Tajo, s/n Urb. El Bosque. 28670, Villaviciosa de Odón, Madrid,
Country 139772 0
Spain
Phone 139772 0
+34667427424
Fax 139772 0
Email 139772 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.