Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000300572
Ethics application status
Approved
Date submitted
8/11/2023
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Gluteal Stretching vs LightBack® on Hip Mobility in Healthy Subjects: A Cross-Over Clinical Trial.
Scientific title
The Effects of Gluteal Stretching vs LightBack® on Passive Hip External Rotation in Healthy Subjects: A Cross-Over Clinical Trial.
Secondary ID [1] 310908 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
decreased hip range of motion 331968 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328697 328697 0 0
Physiotherapy
Musculoskeletal 329209 329209 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, with a one-week washout period between treatments. Checklists were employed to assess patient interventions.

Two stretching techniques will be applied, one on each leg of the subject. The classic gluteal stretch will serve as the control group, while the stretching using the LightBack device will be the experimental group.

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.
Intervention code [1] 327338 0
Prevention
Intervention code [2] 327339 0
Rehabilitation
Comparator / control treatment
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, with a one-week washout period between treatments. Checklists were employed to assess patient interventions.

Control Group: Active control with the other limb-leg
On another day, the subject will perform a gluteal stretch on the other leg. This will be a passive type 1 stretch where the subject, in a supine position, will bring the leg to 90º of hip flexion and external hip rotation with the assistance of the other leg until they feel a stretching sensation. The stretch will have an application time of 30 seconds, and two repetitions will be performed for a total application time of 1 minute. 30 seconds rest between repetitions.
Control group
Active

Outcomes
Primary outcome [1] 336510 0
Passive Hip External rotation range of motion
Timepoint [1] 336510 0
Baseline and Immediately after the treatment
Secondary outcome [1] 428628 0
Active Knee Extension Test (AKE)
Timepoint [1] 428628 0
Baseline and Immediately after the treatment
Secondary outcome [2] 428629 0
Active Straight Leg Raise (aSLR)
Timepoint [2] 428629 0
Baseline and Immediately after the treatment
Secondary outcome [3] 428686 0
Passive Hip Internal Rotation range of motion
Timepoint [3] 428686 0
Baseline and Immediately after the treatment
Secondary outcome [4] 428687 0
Active Hip Internal Rotation range of motion
Timepoint [4] 428687 0
Baseline and Immediately after the treatment
Secondary outcome [5] 428688 0
Active Hip External Rotation range of motion
Timepoint [5] 428688 0
Baseline and Immediately after the treatment

Eligibility
Key inclusion criteria
- Healthy physically active participants
- Maintained a training regimen of at least two days per week
Minimum age
18 Years
Maximum age
30 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)
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Participants will be randomly allocated to receive the intervention stretch on one leg and the comparator stretch will then be applied to the opposite leg.
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 (?2p), 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
15/04/2024
Actual
Date of last data collection
Anticipated
15/04/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 25956 0
Spain
State/province [1] 25956 0
Madrid

Funding & Sponsors
Funding source category [1] 315177 0
University
Name [1] 315177 0
Universidad Europea de Madrid
Country [1] 315177 0
Spain
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
Calle Tajo s/n, Villaviciosa de Odón, Madrid, 28670.
Country
Spain
Secondary sponsor category [1] 317623 0
None
Name [1] 317623 0
Address [1] 317623 0
Country [1] 317623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314101 0
comisión de investigación de la escuela de doctorado e investigación. Universidad Europea de Madrid
Ethics committee address [1] 314101 0
Calle Tajo s/n, Villaviciosa de Odón, 28670, Madrid
Ethics committee country [1] 314101 0
Spain
Date submitted for ethics approval [1] 314101 0
28/07/2023
Approval date [1] 314101 0
11/10/2023
Ethics approval number [1] 314101 0
2023-296

Summary
Brief summary
To determine the effectiveness of a stretch using the LightBack® device vs. a gluteal stretch in healthy subjects' range of motion.
We hypotethize that the LightBack mobilization has a major effect increasing the active and passive hip range of motion, active knee extension and active straight leg raise when compared to gluteal stretch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130414 0
Dr Charles Cotteret
Address 130414 0
Universidad europea de Madrid, Calle tajo sn, villaviciosa de odón, 28670, Madrid.
Country 130414 0
Spain
Phone 130414 0
+34 633 121 139
Fax 130414 0
Email 130414 0
[email protected]
Contact person for public queries
Name 130415 0
Dr Charles Cotteret
Address 130415 0
Universidad Europea de Madrid, Calle tajo sn, villaviciosa de odón, 28670, Madrid.
Country 130415 0
Spain
Phone 130415 0
+34 633 121 139
Fax 130415 0
Email 130415 0
[email protected]
Contact person for scientific queries
Name 130416 0
Dr Charles Cotteret
Address 130416 0
Universidad Europea de Madrid, Calle tajo sn, villaviciosa de odón, 28670, Madrid.
Country 130416 0
Spain
Phone 130416 0
+34 633 121 139
Fax 130416 0
Email 130416 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20845Ethical approval    386839-(Uploaded-08-11-2023-02-50-29)-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.