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Trial registered on ANZCTR


Registration number
ACTRN12622000294752
Ethics application status
Approved
Date submitted
29/07/2020
Date registered
16/02/2022
Date last updated
2/02/2023
Date data sharing statement initially provided
16/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of selected manual therapy techniques on relative length and symmetry of lower limbs loading with body weight.
Scientific title
Impact of selected manual therapy techniques on symmetry of lower limbs loading with body weight in patients with functional asymmetry of lower limbs length
Secondary ID [1] 301855 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower limb asymmetry 318353 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316360 316360 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 316361 316361 0 0
Physiotherapy
Musculoskeletal 322631 322631 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study participants will be about 400 adults aged 19-30 years old, recruited from students of physical education, nursing and physiotherapy at the University of Applied Sciences in Tarnów.
In the study group will be people in whom the difference in load of lower limbs with body weight will be equal to or greater 5% and the control groups will be consisted of two groups people. Each of the participants will be informed in detail about the course of research and asked to give their written consent to participate in the project.
Additionally, before being assigned to one of the three study groups, the lower limbs relative length will be measured. All the maneuvers (manipulations / mobilizations) will be performed towards the shorter limb.
Patients from the study group will be randomly assigned to one of three groups:
• Group I 40 participants: people from group I will have a one-time manual procedure (manipulation) of low strength and low amplitude in the C2 region. Intervention (manipulation) will be applied once only. The approximate duration of the intervention is 20 minutes, with 10 minutes of manual therapy applied).
Manipulation targeted to the C2 or global segment in the cervical segment will be carried out towards the functionally shortened limb. Mobilization of the sacroiliac joint in the direction of extension of the lower limb will be carried out on the functionally shortened limb side.
Manual procedure targeted in the region of C2 - rotation manipulation
This procedure will be performed after prior exclusion of contraindications to its use. Patient in a sitting position. The therapist stands on the relatively shortened side facing the participant. Manipulation for rotation will be performed towards the relatively shortened limb. The therapist's hands are arranged in such a way that one covers the occiput and the middle finger of the other hand the arch of the C2 vertebra, e.g. if the relative shortening of the lower limb is on the right side of the subject, the therapist stands on the other side facing the front and his left hand covers the occiput and the middle finger of the right arm of the C2 vertebra. Then the therapist makes the patient's head move to inflection, lateral contralateral contraction and ipsilateral rotation in such a way as to achieve the pre-stress - the barrier. When the barrier is obtained, the therapist performs the so-called "Manipulative push" at level C2.

• Group II 40 participants: people from Group II will be performed once with a global manual procedure (manipulation) for the entire cervical spine with low strength and low amplitude. Intervention (manipulation) will be applied once only. The approximate duration of the intervention is 20 minutes, with 10 minutes of manual therapy applied.
Global manual procedure for low force and low amplitude rotation within the cervical spine
This procedure will be performed after prior exclusion of contraindications to its use. Manipulation for rotation will be performed towards the relatively shortened limb. The therapist sits behind the subject, resting his back on his chest. The thumb of one of the therapist's hands covers the patient's lower nape and the fingers from 2-5 are placed on the temporal and zygomatic bones. The fingers of the other hand are arranged so that the pointer lies on the branch of the jaw and the thumb on the outgrowth of the C7 vertebra. Arranged hands perform slight inflection, lateral contralateral flexion and opposite rotation to the flexion. After reaching the barrier, the therapist performs the so-called "Manipulative push" on all segments of the cervical spine towards the functionally shortened limb.

• Group III 40 participants: for people from Group III a single mobilization for extension in sacroiliac joint will be performed - Kowtuna grip. Intervetion will be applied once only. The approximate duration of the intervention is 20 minutes, with 10 minutes of manual therapy applied. Intervention (mobilization) will be applied only once.
Mobilization of the sacroiliac joint towards extension in the hip joint (Kowtuna technique)
This procedure will be performed after the exclusion of contraindications for mobilization. Participant in the supine position, the therapist stands on the side of the shorter limb facing the participant. If the participant has a relative shortening of the right lower limb, then the therapist faces the participant on the right at hip height
With the left hand, the therapist bends passively the participant's right lower limb in the knee joint, embracing his thigh above the knee from the inside, and the participant's lower leg rests on the therapist's forearm and shoulder. The therapist's right hand's fingers directed toward the caudal side and the edge of the 5 metacarpal bone and the pisifirm bone pressed on the posterior iliac spine, upper right.
The therapist asks participant to breathe in while simultaneously using his left hand to extend the right hip joint to reach the barrier. When the participant exhales, the therapist's left hand deepens extension in the right hip joint, reaching a new barrier. At the same time, the therapist's right hand presses the edge of the fifth metacarpal bone and the pisiform bone on the posterior posterior iliac spine in the abdominal and caudal direction
In the case of a relative shortening of the left lower limb, we proceed in the same way as in the case of a relative shortening of the right lower limb.
All manual procedures and measurements will be made by the same therapist (with 35 years of experience), a manual therapy instructor training doctors and physiotherapists in this field.
Intervention code [1] 318167 0
Treatment: Other
Intervention code [2] 322834 0
Rehabilitation
Comparator / control treatment
The control group will be consisted of two groups people:
First control group about 200 people: people whose lower body weight difference will be less than 5%, who do not undergo any therapeutic procedure
Second control group about 80 people: people who have a lower body weight difference equal to or greater than 5%, who do not undergo any therapeutic procedure. Participants whose lower body weight difference is equal to or greater than 5% will be randomly assigned to the second control group
Control group
Active

Outcomes
Primary outcome [1] 324547 0
Assessment of the impact of selected manual techniques on the symmetries of lower limb loadings with body weight in young adults they do not have structural changes in the locomotor system. The change in body weight loading will be assessed using the BTS-P walk baroresistive platform.
Timepoint [1] 324547 0
At baseline (test 1), 10 minutes after manipulation (test 2), immediately after 2 weeks (test 3)
Secondary outcome [1] 384951 0
Which of the following manual therapy techniques brings the best results in equalizing the relative length of the lower limbs? The relative length of the lower limbs will be assessed using a centimeter tape. The measurement takes into account the distance from the anterior superior iliac spine to the medial malleolus. The measurement will be taken on both lower limbs.
Timepoint [1] 384951 0
At baseline (test 1), 10 minutes after manipulation (test 2), immediately after 2 weeks (test 3)
Secondary outcome [2] 384952 0
Analysis of the impact of selected manual therapy techniques on body balance. The change in body balance will be assessed using the BTS-P walk baroresistive platform.
Timepoint [2] 384952 0
At baseline (test 1), 10 minutes after manipulation (test 2), immediately after 2 weeks (test 3)
Secondary outcome [3] 384953 0
Analysis of the impact of selected manual therapy techniques on loading of selected foot zones. The change on loading selected foot zones will be assessed using the BTS-P walk baroresistive platform.
Timepoint [3] 384953 0
At baseline (test 1), 10 minutes after manipulation (test 2), immediately after 2 weeks (test 3)

Eligibility
Key inclusion criteria
- The asymmetry in the relative length of the lower limbs and the asymmetry of the load with the body weight
- no significant injuries that have led to structural changes within the musculoskeletal system,
- no current pain syndrome present in the musculoskeletal system,
- no symptoms suggestive of vertebrobasilar insufficiency.
Minimum age
19 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• injuries of the musculoskeletal system in the last 6 weeks before the examination,
• previous fractures in the musculoskeletal system,
• neurological deficits,
• dizziness, nausea, imbalance,
• sudden falls without a reason (drop attacks),
• rheumatic diseases,
• metabolic diseases, e.g. diabetes,
• general poor health,
• mental disorders,
• manipulation of the spine performed in the last 10 days before the examination.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To assess the correlation coefficient of chosen variables two statistical test will be used – Chi square (x2) and t-Student. For all compared variables the level of relevancywill set at alpha=0,05 (p<0,05). The correlation coefficient with probability of p<0,01 will be recognized as highly relevant, and correlation coefficient with probability of p<0,001 will be recognized as extremely relevant. Determining whether the algorithm used in manual therapy that elongation of the lower limb functionally shorter improves the load symmetry coefficient in young people without structural changes in the motor organ is true.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/11/2015
Date of last participant enrolment
Anticipated
Actual
4/10/2021
Date of last data collection
Anticipated
15/04/2022
Actual
31/12/2022
Sample size
Target
400
Accrual to date
Final
372
Recruitment outside Australia
Country [1] 22797 0
Poland
State/province [1] 22797 0
Tarnow

Funding & Sponsors
Funding source category [1] 306278 0
Self funded/Unfunded
Name [1] 306278 0
Teresa Gniewek
Country [1] 306278 0
Poland
Primary sponsor type
Individual
Name
Teresa Gniewek
Address
University of Physical Education in Cracow
al. Jana Pawla II 78
31-571 Kraków
Country
Poland
Secondary sponsor category [1] 306820 0
None
Name [1] 306820 0
Address [1] 306820 0
Country [1] 306820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306494 0
Bioethics Commission at the Regional Medical Chamber in Tarnow
Ethics committee address [1] 306494 0
ul. Moscickiego 16, 33-100 Tarnow
Ethics committee country [1] 306494 0
Poland
Date submitted for ethics approval [1] 306494 0
Approval date [1] 306494 0
19/02/2015
Ethics approval number [1] 306494 0
1/0177/2015

Summary
Brief summary
The aim of the study will be to determine the influence of selected manual techniques on the symmetry of lower limb loading and the change in the relative length of the lower limbs in young people aged 19-30, without any structural changes in the musculoskeletal system. Thanks to this, we will find out which type of manipulation or mobilization will affect the fact that the patient will be equally burdening the right and left lower limb.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104058 0
Mrs Teresa Gniewek
Address 104058 0
University of Physical Education in Cracow
al. Jana Pawla II 78,
31-571 Kraków
Country 104058 0
Poland
Phone 104058 0
+48 606436476
Fax 104058 0
Email 104058 0
[email protected]
Contact person for public queries
Name 104059 0
Teresa Gniewek
Address 104059 0
University of Physical Education in Cracow
al. Jana Pawla II 78,
31-571 Kraków
Country 104059 0
Poland
Phone 104059 0
+48 606436476
Fax 104059 0
Email 104059 0
[email protected]
Contact person for scientific queries
Name 104060 0
Teresa Gniewek
Address 104060 0
University of Physical Education in Cracow
al. Jana Pawla II 78,
31-571 Kraków
Country 104060 0
Poland
Phone 104060 0
+48 606436476
Fax 104060 0
Email 104060 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
8629Ethical approval  [email protected]
8630Informed consent form  [email protected] 380250-(Uploaded-28-10-2021-17-32-40)-Study-related document.pdf



Results publications and other study-related documents

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