Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000160730
Ethics application status
Approved
Date submitted
20/10/2021
Date registered
31/01/2022
Date last updated
30/01/2023
Date data sharing statement initially provided
31/01/2022
Date results information initially provided
30/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of specific closed kinematic chain excercises with biofeedback assissted position control and against forces enhancing positional disorder on lower limb movement pattern
Scientific title
Effects of closed kinematic chain exercises with active auto-correction of artificially enhanced disorders of the lower limbs positioning on their movement pattern in adults
Secondary ID [1] 305594 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional disturbances of Lower limbs axis 324021 0
Condition category
Condition code
Musculoskeletal 321528 321528 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 322129 322129 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions is basically an exercises with resistance of the lower limbs in closed biokinematic chains, performed with modified "Leg-press" device. This kind of device allows only movement of extension and flexion of lower limbs against resistance - in this specific device (TELKO, manufactured/ distributed byACX/Technomex, Poland) resistance is created from elastic tubing. The only exercise performed will be flexion/ extension of lower limbs in closed kinematic chain made simultaneously for both limbs. The device uses virtual reality visual games to maintain patient focus in training and control parameters like force distribution between left/ right leg. The modification from standard training is due to active correction of the position of the feet and the axis of the lower limbs performed by the strength of the patient's own muscles, against the force disturbing this setting towards the valgus of the knees. The disturbing force will be realized through an elastic band (medium strength). The control of the position of the feet and the axis of the lower limbs will be performed with the use of biofeedback phenomenon and additional controls ( two on upper lowel leg, responsible for lower legs axis, and two on foot, responsible for keeping correct position / pressure of the foot).
The exercises will last 15 minutes daily, with resistance and fatigue desribed by the patient as moderate to heavy but pleasant (3 to 5 in ten point Borg Scale). This exercise will be performed individually, as we have only one such device.
As every participant will have individual account on the device software, report from every training session will be recorded and used for control of attendance and participation in training session.
Speed of excercise - according to patient possibilities, but with instructions that primary goal is to perform the exercise correctly (according to attached controls described above) not speed or fatigue.
Excercises will be performed for 5 days between the initial and final assessment - to avoid effects of muscle strengtening, instead of motor contol effect.
Intervention will be delivered by Physiotherapist with active right to physiotherapy practice.
The research will be held at "Pod Tezniami" Health Resort and Physiotherapy center in Ciechocinek, Poland.
All patients will receive the patient's informed consent form to participate in the research, they will be informed in detail about the course of the research and that they can resign from participation at any time.
Intervention code [1] 321993 0
Rehabilitation
Comparator / control treatment
Interventions is basically an exercises with resistance of the lower limbs in closed biokinematic chains, performed with modified "Leg-press" device. This kind of device allows only movement of extension and flexion of lower limbs against resistance - in this specific device (TELKO, manufactured/ distributed byACX/Technomex, Poland) resistance is created from elastic tubing. The only exercise performed will be flexion/ extension of lower limbs in closed kinematic chain made simultaneously for both limbs. The device uses virtual reality visual games to maintain patient focus in training and control parameters like force distribution between left/ right leg. Exercise will be conducted without modifications described for research group.
The exercises will last 15 minutes daily, with resistance and fatigue desribed by the patient as moderate to heavy but pleasant (3 to 5 in ten point Borg Scale). This exercise will be performed individually, as we have only one such device.
As every participant will have individual account on the device software, report from every training session will be recorded and used for control of attendance and participation in training session.
Speed of excercise - according to patient possibilities, but with instructions that primary goal is to perform the exercise correctly by patient own visual observation of lower limb axis
Excercises will be performed for 5 days between the initial and final assessment - to avoid effects of muscle strengtening, instead of motor contol effect.
Intervention will be delivered by Physiotherapist with active right to physiotherapy practice.
The research will be held at "Pod Tezniami" Health Resort and Physiotherapy center in Ciechocinek, Poland.
All patients will receive the patient's informed consent form to participate in the research, they will be informed in detail about the course of the research and that they can resign from participation at any time.
Control group
Active

Outcomes
Primary outcome [1] 329293 0
Foot Posture Index in Standing
Timepoint [1] 329293 0
After 5-days training
Primary outcome [2] 329294 0
Distribution of feet loading during sitting/ standing up - non-invasive, on baroresistive / stabilometric platform
Timepoint [2] 329294 0
After 5-days training
Primary outcome [3] 329296 0
Axis of lower legs during sitting/ standing up - non invasive 3-d motion analysis (Miomotion, Zebris or Ninox optical camera)
Timepoint [3] 329296 0
After 5-days training
Secondary outcome [1] 402040 0
Movement of center of pressure in standing - Non invasive - stabilometric or baroresistive platform
Timepoint [1] 402040 0
After 5-days training
Secondary outcome [2] 402041 0
Height of longitudinal arch during exercise - non invasive - picture with scale (mm) visible
Timepoint [2] 402041 0
During excercise
Secondary outcome [3] 402042 0
Electric Activity of chosen lower limbs muscles during excercise (fEMG) -vastus lateralis and medialis muscles, tibialis anterior and peroneus longus - non-invasive, with surface EMG device
Timepoint [3] 402042 0
During excercise
Secondary outcome [4] 402043 0
Axis of lower limb during performance of excercise- non invasive 3-d motion analysis (Miomotion, Zebris or Ninox optical camera)
Timepoint [4] 402043 0
During excercise
Secondary outcome [5] 402044 0
Maximal Isometric force of hip flexors and extensors - Non invasive, hand electrical dynamometer
Timepoint [5] 402044 0
After 5-days training
Secondary outcome [6] 402045 0
range of passive and active movement in the first metatarsophalangeal joint - Non Invasive, goniomety
Timepoint [6] 402045 0
After 5-days training
Secondary outcome [7] 402046 0
Ground reaction forces during gait on baroresistive platform (non-invasive)
Timepoint [7] 402046 0
After 5-days training
Secondary outcome [8] 404192 0
Maximal Isometric force of hip abductors - Non invasive, hand electrical dynamometer
Timepoint [8] 404192 0
After 5-days training
Secondary outcome [9] 404193 0
Maximal Isometric force of hip external rotators - Non invasive, hand electrical dynamometer
Timepoint [9] 404193 0
After 5-days training
Secondary outcome [10] 405625 0
Maximal Isometric force of knee flexors and extensors - Non invasive, hand electrical dynamometer
Timepoint [10] 405625 0
After 5-days training

Eligibility
Key inclusion criteria
Occurrence of disturbances in the position of the lower limbs during resistance Closed Kinematic chain exercises - deviation of the knees inwards with equal load on the outer and inner parts of the feet, or loading of external part of the foot while maintaining axis of a lower legs
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Inability to achieve the correctlower limb position during the exercise.
• Presence of significant pain in the lower limbs or the spine during the examination/ treatment
• Presence of congenital or traumatic defects related to deformations of the lower limbs, including the feet.
• Presence of weakness in the muscles of the lower extremities associated with impaired innervation or muscle atrophy.
• Occurrence of joint or muscle contractures of a structural nature, preventing the proper performance of the exercises.
• Previous lower limb correction surgery, partial or total lower limb arthroplasty
• Previous lumbar spine surgeries
• Contraindications to physical exercise in general, resistance exercises of the lower limbs in particular, including those related to the cardiovascular and nervous systems
• Degenerative changes in the joints of the lower extremities, grade III or IV, coexisting with pain
• Neurological disorders and diseases negatively affecting the control of lower limbs functions
• Lack of or limited contact with physiotherapist conducting the interventions, making it impossible to explain and / or understand the test conditions
• Using during the examination or within 2 days before it, targeted treatments correcting the settings of the pelvis and lower limbs, in particular manual therapy, osteopathic procedures, exercises according to neurophysiological methods or individual exercises with a therapist.
• Significant visual impairment and / or hearing loss making it difficult to use the Biofeedback phenomenon during exercise

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Six walls dice will be used.
Paired number will be for research group
Non-paired for control group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to literature and our possibilities, number of participants was specified as 80 to 120 persons, divided for both groups

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2022
Actual
16/02/2022
Date of last participant enrolment
Anticipated
3/06/2022
Actual
7/04/2022
Date of last data collection
Anticipated
25/06/2022
Actual
20/04/2022
Sample size
Target
120
Accrual to date
Final
109
Recruitment outside Australia
Country [1] 24235 0
Poland
State/province [1] 24235 0
Kujawsko-pomorskie voivodenship

Funding & Sponsors
Funding source category [1] 309958 0
Commercial sector/Industry
Name [1] 309958 0
PHU Technomex, sp. z o. o.
Country [1] 309958 0
Poland
Primary sponsor type
Individual
Name
Michal Dylewski
Address
Klinika Uzdrowiskowa "Pod Tezniami" im. Jana Pawla II, SUM
Michal Dylewski
Warzelniana 7
87-720 Ciechocinek
Country
Poland
Secondary sponsor category [1] 311003 0
None
Name [1] 311003 0
Address [1] 311003 0
Country [1] 311003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309673 0
University of Mikolaj Kopernik in Torun, Colegium Medicum Bioethical Comitee
Ethics committee address [1] 309673 0
Ul. Marii Curie-Sklodowskiej 9
85-094 Bydgoszcz
Ethics committee country [1] 309673 0
Poland
Date submitted for ethics approval [1] 309673 0
04/01/2018
Approval date [1] 309673 0
16/01/2018
Ethics approval number [1] 309673 0
KB 59/2018

Summary
Brief summary
Bioethical comitee aproval was extended to the june of 2022 in attachment.

This approval is for wider range research, inckluding except described trial also assessment of effectiveness of Dynamic Taping for lower part of Spiral Line according to Myers.

Both interventions (excercises described in this registartion) and dynamic taping share the same inclusion/ exclusion criteria, recruitment method and outcomes.

Research are taken to confirm/ proof effects observed subjectively in clinical work on individual basis with dysfunctional patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114990 0
Mr Michal Dylewski
Address 114990 0
Klinika Uzdrowiskowa "Pod Tezniami" im. Jana Pawla II, SUM
Michal Dylewski
Warzelniana 7
87-720 Ciechocinek
Country 114990 0
Poland
Phone 114990 0
+48 609968793
Fax 114990 0
Email 114990 0
micdyl@o2.pl
Contact person for public queries
Name 114991 0
Mr Michal Dylewski
Address 114991 0
Klinika Uzdrowiskowa "Pod Tezniami" im. Jana Pawla II, SUM
Michal Dylewski
Warzelniana 7
87-720 Ciechocinek
Country 114991 0
Poland
Phone 114991 0
+48 609968793
Fax 114991 0
Email 114991 0
micdyl@o2.pl
Contact person for scientific queries
Name 114992 0
Mr Michal Dylewski
Address 114992 0
Klinika Uzdrowiskowa "Pod Tezniami" im. Jana Pawla II, SUM
Michal Dylewski
Warzelniana 7
87-720 Ciechocinek
Country 114992 0
Poland
Phone 114992 0
+48 609968793
Fax 114992 0
Email 114992 0
micdyl@o2.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to European Commission regulations regarding personal data.


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.