Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000980336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/04/2026
Date registered
Help: Date registered
10/08/2026
Date last updated
Help: Date last updated
10/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/08/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Effects of motor training and biofeedback on movement, brain activity and balance in women with chronic low back pain
Scientific title
Neurobiomechanical reorganization of motor control following functional motor training and biofeedback-based training in women aged 35–50 years with chronic low back pain: a randomized controlled trial
Additional trial identifiers [1] 316874 0
nil
Universal Trial Number (UTN)
Trial acronym
MCT-BF-CLBP
Related trial records
nil

Health condition
Health condition(s) studied:
Non-specific chronic low back pain 341476 0
Condition category
Condition code
Musculoskeletal 337565 337565 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 338539 338539 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1: Functional motor training (MCT)

Participants performed a structured functional motor training program for 8 weeks (2 sessions per week) under the supervision of a physiotherapist. Each session lasted approximately 45 minutes and was delivered in small groups. Sessions were conducted twice weekly with at least 48 hours between sessions. Exercise intensity was maintained at a moderate level and was individually adjusted according to participant tolerance and progression.

The program consisted of three components: (1) motor control and stabilization exercises focusing on the lumbopelvic region, (2) strengthening exercises (e.g. squats, deadlifts, hip bridge, dead bug, Pallof press), and (3) stretching exercises aimed at improving flexibility and reducing muscle tension.

Adherence to the intervention was monitored using attendance records completed by the supervising physiotherapist at each session.

Arm 2: Functional motor training with biofeedback (MCT-BF)

Participants performed the same functional motor training program as in Arm 1, with additional biofeedback-based training. Each session lasted approximately 60 minutes, including 15 minutes of biofeedback training performed on ALFA and SIGMA stabilometric platforms. Sessions were delivered in small groups under the supervision of a physiotherapist and were conducted twice weekly with at least 48 hours between sessions.

The biofeedback component consisted of static and dynamic balance exercises and proprioceptive tasks performed on stabilometric platforms. Participants received real-time visual feedback displayed on a monitor regarding body sway and centre of pressure displacement. Interactive game-based tasks requiring weight shifting, balance control, and postural adjustments were also performed. The purpose of the biofeedback training was to improve postural control, proprioception, and neuromuscular coordination.

Exercise intensity was maintained at a moderate level and was individually adjusted according to participant tolerance and progression. Adherence to the intervention was monitored using attendance records completed by the supervising physiotherapist at each session.

Arm 3: Control group (CG)

Participants in the control group did not receive any intervention during the study period and were instructed to continue their usual daily activities. Outcome assessments were performed at the same time points as in the intervention groups.
Intervention code [1] 333749 0
Rehabilitation
Intervention code [2] 333750 0
Treatment: Other
Intervention code [3] 333751 0
Lifestyle
Description of the comparator or control
The control group consisted of participants who did not receive any therapeutic intervention during the study period. They continued their usual daily activities without structured exercise or physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 345044 0
Change in lumbopelvic range of motion assessed using 3D motion analysis (BTS SMART-D) between baseline (T1), post-intervention (T2), and follow-up (T3).
Timepoint [1] 345044 0
Baseline (T1), immediately post-intervention (T2, after 8 weeks), and follow-up (T3, 12 weeks after baseline)
Primary outcome [2] 345045 0
Change in brain bioelectrical activity assessed using 64-channel EEG (eego sports system) during rest and functional tasks between baseline (T1), post-intervention (T2), and follow-up (T3). This will be assessed as a composite primary outcome.
Timepoint [2] 345045 0
Baseline (T1), immediately post-intervention (T2, after 8 weeks), and follow-up (T3, 12 weeks after baseline).
Primary outcome [3] 345814 0
Change in lumbopelvic movement quality assessed using 3D motion analysis (BTS SMART-D) between baseline (T1), post-intervention (T2), and follow-up (T3).
Timepoint [3] 345814 0
Baseline (T1), immediately post-intervention (T2, after 8 weeks), and follow-up (T3, 12 weeks after baseline).
Secondary outcome [1] 460270 0
Change in balance parameters assessed using stabilometric platforms (ALFA and SIGMA), including center of pressure displacement, sway velocity, and ellipse area between T1, T2, and T3. This will be assessed as a composite secondary outcome.
Timepoint [1] 460270 0
Baseline (T1), immediately post-intervention (T2, after 8 weeks), and follow-up (T3, 12 weeks after baseline)
Secondary outcome [2] 460273 0
Change in mood states between baseline (T1), post-intervention (T2), and follow-up (T3). This will be assessed as a composite secondary outcome.
Timepoint [2] 460273 0
Baseline (T1), immediately post-intervention (T2, after 8 weeks), and follow-up (T3, 12 weeks after baseline)
Secondary outcome [3] 460274 0
Change in perceived stress levels between baseline (T1), post-intervention (T2), and follow-up (T3).
Timepoint [3] 460274 0
Baseline (T1), immediately post-intervention (T2, after 8 weeks), and follow-up (T3, 12 weeks after baseline)

Eligibility
Key inclusion criteria
- Female participants aged 35–50 years
- Chronic low back pain lasting at least 12 weeks
- Body mass index (BMI) between 18.5 and 30 kg/m²
- Ability to participate in physical training and functional testing
- Ability to complete psychological questionnaires
- No severe psychiatric disorders
- Written informed consent to participate in the study
Minimum age
35 Years
Maximum age
50 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
- Acute or severe chronic diseases (e.g. infections)
- Autoimmune diseases (e.g. rheumatoid arthritis, multiple sclerosis, lupus)
- Active or past cancer
- Advanced degenerative spinal changes or acute disc herniation
- Cardiovascular diseases (e.g. heart failure, arrhythmia)
- Endocrine disorders (e.g. diabetes, thyroid disorders)
- Neurological disorders (e.g. epilepsy, neurodegenerative diseases)
- Use of painkillers, anti-inflammatory or psychotropic medications
- Substance abuse
- Severe psychiatric disorders
- Cognitive impairment
- Sleep disorders
- Pregnancy or breastfeeding

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 concealment was ensured using sealed opaque envelopes prepared prior to participant enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly allocated to groups using a computer-generated randomisation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will include repeated measures ANOVA to assess the effects of intervention over time and between groups. Assumptions of normality (Shapiro-Wilk test) and sphericity (Mauchly’s test) will be evaluated, with appropriate corrections (Greenhouse-Geisser or Huynh-Feldt) applied if necessary. Post-hoc analyses (Bonferroni or Tukey) will be conducted to identify specific group differences. Effect sizes (?² and Cohen’s d) will be calculated. For non-parametric data, Friedman and Wilcoxon tests will be used. Correlation analyses (Pearson or Spearman) and multiple regression analyses will be performed to identify predictors of treatment outcomes. All analyses will be conducted using R software.
Associations between baseline temperament characteristics and changes in primary and secondary outcomes will be explored using correlation and multiple regression analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2025
Date of last participant enrolment
Anticipated
Actual
19/12/2025
Date of last data collection
Anticipated
Actual
19/03/2026
Sample size
Target
45
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 28021 0
Poland
State/province [1] 28021 0

Funding & Sponsors
Funding source category [1] 321472 0
University
Name [1] 321472 0
University of Physical Culture in Krakow
Country [1] 321472 0
Poland
Primary sponsor type
University
Name
University of Physical Culture in Krakow
Address
Country
Poland
Secondary sponsor category [1] 324400 0
None
Name [1] 324400 0
Address [1] 324400 0
Country [1] 324400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320005 0
Bioethics Committee of the District Medical Chamber in Krakow
Ethics committee address [1] 320005 0
Ethics committee country [1] 320005 0
Poland
Date submitted for ethics approval [1] 320005 0
Approval date [1] 320005 0
31/07/2025
Ethics approval number [1] 320005 0

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

Contacts
Principal investigator
Name 149118 0
Ms Aleksandra Adamik
Address 149118 0
University of Physical Culture in Krakow; al. Jana Pawla II 78 31-571 Krakow
Country 149118 0
Poland
Phone 149118 0
+48664125701
Fax 149118 0
Email 149118 0
[email protected]
Contact person for public queries
Name 149119 0
Aleksandra Adamik
Address 149119 0
University of Physical Culture in Krakow; al. Jana Pawla II 78 31-571 Krakow
Country 149119 0
Poland
Phone 149119 0
+48664125701
Fax 149119 0
Email 149119 0
[email protected]
Contact person for scientific queries
Name 149120 0
Aleksandra Adamik
Address 149120 0
University of Physical Culture in Krakow; al. Jana Pawla II 78 31-571 Krakow
Country 149120 0
Poland
Phone 149120 0
+48664125701
Fax 149120 0
Email 149120 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Access to de-identified individual participant data will be granted upon reasonable request for scientific purposes. Requests will be evaluated by the study investigator, and data sharing will be subject to ethical approval, institutional regulations, and data protection requirements.



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.