Biomechanical PhenomenaNCT04861350
Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 2
A study testing motor imagery with action observation, physical training and combine physical training and motor imagery with action observation in people with Biomechanical Phenomena, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Hip motor control ability is an important parameter for preventing sport injuries in lower limbs, and the training of hip motor control can enhance the lower extremity movement performance. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Biomechanical Phenomena
- What is being tested?
- motor imagery with action observation, physical training and combine physical training and motor imagery with action observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- without pain or symptoms on lower extremities or spine which affects on daily activities or sports participants lasting for more than 1 week within 6 months.
Who cannot join
- any symptoms or surgery history on lumbar or lower extremities in the past 6 months and still interrupt daily activities or sports participants.
- any neurological or psychosocial disease affects on motor imagery ability.
- with drug or alcohol abuse history.
- with visual or vestibular abnormalities without correction, or with concussion history within 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(2)
Hip motor control ability is an important parameter for preventing sport injuries in lower limbs, and the training of hip motor control can enhance the lower extremity movement performance. Previous studies have demonstrated the benefits of motor imagery with action observation (AOMI) on motor control and muscle strength improvements, which also revealed that AOMI combined with physical training (AOMI-PT) can lead to better outcomes than physical training (PT) alone. Besides, monitoring the neurophysiological changes of brain activation and the functional connection to the peripheral muscular activation after training helps to understanding the mechanisms on the training effects.
Therefore, the aim of this study is to compare (1) the cortical control mechanisms between 3 types of motor control training strategies; and (2) the effects of 3 types of motor control training on hip motor control performance in healthy subjects.
Read the detailed description
Hip motor control ability is an important parameter for preventing sport injuries in lower limbs, and the training of hip motor control can enhance the lower extremity movement performance. Previous studies have demonstrated the benefits of motor imagery with action observation (AOMI) on motor control and muscle strength improvements, which also revealed that AOMI combined with physical training (AOMI-PT) can lead to better outcomes than physical training (PT) alone. Besides, monitoring the neurophysiological changes of brain activation and the functional connection to the peripheral muscular activation after training helps to understanding the mechanisms on the training effects.
Therefore, the aim of this study is to compare (1) the cortical control mechanisms between 3 types of motor control training strategies; and (2) the effects of 3 types of motor control training on hip motor control performance in healthy subjects.
The investigators will recruit 45 healthy subjects and compare the effect of three types of motor control training (physical training, motor imagery with action observation, physical training combined motor imagery with action observation) on Y balance test performance, cortico-muscular coherence (CMC), and task-related spectral power (TRSP) changes. Due to only few studies about the issue, we will recruit extra 15 healthy athletes for pilot study to investigate the reliability of the research measurements and refine the protocols.
Chi squared test is used to examine the group differences such as gender, dominant side and activity level. The 2-way mixed analysis of variance (ANOVA) will be used to compare the intervention effect on motor control test and CMC between groups. One-way repeated measures ANOVA will be used to investigate the neurophysiological changes on brain activation during AOMI training, and the changes of AOMI-PT and PT group will be compared by independent t-test. The alpha level was set at 0.05.
- Conditions
- Biomechanical Phenomena
- Being tested
- motor imagery with action observation, physical training, combine physical training and motor imagery with action observation
- Keywords
- motor control, imagery training, corticomuscular coherence, event-related synchronization/ desynchronization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor imagery with action observationOther
Standing clamshell exercise with elastic band, sliding, and Romanian deadlift exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, the subjects will mentally simulate each exercise with video 10 times for a set, 3 sets totally. With 2 min interval between each sets, it will take approximately 8 minutes to finish each movement. It will also take 3 min for resting between each program.
physical trainingOther
Standing clamshell exercise with elastic band, sliding, and Romanian deadlift exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, the subjects will physically perform each exercise with supervision of investigator 10 times for a set, 3 sets totally. With 2 min interval between each sets, it will take approximately 8 minutes to finish each movement. It will also take 3 min for resting between each program.
combine physical training and motor imagery with action observationOther
Standing clamshell exercise with elastic band, sliding, and Romanian deadlift exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, each exercises will be mentally simulated with video for a set and physically performed with supervision of investigator for 2 sets, 10 times for each set and 3 sets totally. With 2 min interval between each sets, it will take approximately 8 minutes to finish each movement. It will also take 3 min for resting between each program.
| Study group | Role | What they receive |
|---|---|---|
| motor imagery with action observation | Experimental | The subjects will perform the exercises mentally for 3 sets with video, 10 reps for 1 set. Receives: Other: motor imagery with action observation |
| physical training | Experimental | The subjects will perform the exercise physically for 3 sets with supervision of investigator, 10 reps for 1 set. Receives: Other: physical training |
| combine physical training and motor imagery with action observation | Experimental | The subjects will perform the exercise mentally with video for 1 set and physically with supervision of investigator for 2 sets, 3 sets totally, 10 reps for 1 set. Receives: Other: combine physical training and motor imagery with action observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor control ability
The subjects will stand on Y-balance kit with their dominant leg and reach their non-dominant legs to anterior, posterolateral and posteromedial direction following the tempo with 5 sec forward and 5 sec backward in sequence. The subjects will practice 4 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subjects' lower limb length for statistical analysis.
Measured: pre-intervention
Cortico-muscular coherence
The investigator will place 64-leads EEG on subjects' head and bipolar surface EMG(MP150, BIONOMADIX; BIOPAC, Systems, Inc.) on subjects' internal oblique abdominis, gluteus medius, gluteal maximus and adductor longus. The investigator will collect the signals and process them into cortico-muscular coherence as the functional connection between cortex and muscle during motor control task.
Measured: pre-intervention
Task-related spectral power
The investigator will collect the EEG signals from subjects during the intervention, and the signals will be band-pass filtered (3-60 Hz) and processed with power spectrum density analysis to calculate frequency power at alpha (8-12 Hz) and beta (13-30 Hz) bands. The training data will be normalized with resting values to determine task-related synchronization or desynchronization, which represent the cortical activation changes during training.
Measured: immediately after the intervention
Motor control ability
The subjects will stand on Y-balance kit with their dominant leg and reach their non-dominant legs to anterior, posterolateral and posteromedial direction following the tempo with 5 sec forward and 5 sec backward in sequence. The subjects will practice 4 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subjects' lower limb length for statistical analysis.
Measured: immediately after the intervention
Cortico-muscular coherence
The investigator will place 64-leads EEG on subjects' head and bipolar surface EMG(MP150, BIONOMADIX; BIOPAC, Systems, Inc.) on subjects' internal oblique abdominis, gluteus medius, gluteal maximus and adductor longus. The investigator will collect the signals and process them into cortico-muscular coherence as the functional connection between cortex and muscle during motor control task.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Mar 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomechanical PhenomenaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, Ph.D, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861350
- Sponsor's protocol ID
- YM110027E(2)
- Status last verified
- Nov 2023
- First submitted
- 13 Apr 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(2)
- ClinicalTrials.gov ID
- NCT04861350
- Acronym / sponsor ID
- YM110027E(2)
- Conditions
- Biomechanical Phenomena
- Keywords
- motor control, imagery training, corticomuscular coherence, event-related synchronization/ desynchronization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip motor control ability is an important parameter for preventing sport injuries in lower limbs, and the training of hip motor control can enhance the lower extremity movement performance. Previous studies have demonstrated the benefits of motor imagery with action observation (AOMI) on motor control and muscle strength improvements, which also revealed that AOMI combined with physical training (AOMI-PT) can lead to better outcomes than physical training (PT) alone. Besides, monitoring the neurophysiological changes of brain activation and the functional connection to the peripheral muscular activation after training helps to understanding the mechanisms on the training effects.
Therefore, the aim of this study is to compare (1) the cortical control mechanisms between 3 types of motor control training strategies; and (2) the effects of 3 types of motor control training on hip motor control performance in healthy subjects.
Detailed description
Hip motor control ability is an important parameter for preventing sport injuries in lower limbs, and the training of hip motor control can enhance the lower extremity movement performance. Previous studies have demonstrated the benefits of motor imagery with action observation (AOMI) on motor control and muscle strength improvements, which also revealed that AOMI combined with physical training (AOMI-PT) can lead to better outcomes than physical training (PT) alone. Besides, monitoring the neurophysiological changes of brain activation and the functional connection to the peripheral muscular activation after training helps to understanding the mechanisms on the training effects.
Therefore, the aim of this study is to compare (1) the cortical control mechanisms between 3 types of motor control training strategies; and (2) the effects of 3 types of motor control training on hip motor control performance in healthy subjects.
The investigators will recruit 45 healthy subjects and compare the effect of three types of motor control training (physical training, motor imagery with action observation, physical training combined motor imagery with action observation) on Y balance test performance, cortico-muscular coherence (CMC), and task-related spectral power (TRSP) changes. Due to only few studies about the issue, we will recruit extra 15 healthy athletes for pilot study to investigate the reliability of the research measurements and refine the protocols.
Chi squared test is used to examine the group differences such as gender, dominant side and activity level. The 2-way mixed analysis of variance (ANOVA) will be used to compare the intervention effect on motor control test and CMC between groups. One-way repeated measures ANOVA will be used to investigate the neurophysiological changes on brain activation during AOMI training, and the changes of AOMI-PT and PT group will be compared by independent t-test. The alpha level was set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| motor imagery with action observation | Experimental | Other: motor imagery with action observationThe subjects will perform the exercises mentally for 3 sets with video, 10 reps for 1 set. |
| physical training | Experimental | Other: physical trainingThe subjects will perform the exercise physically for 3 sets with supervision of investigator, 10 reps for 1 set. |
| combine physical training and motor imagery with action observation | Experimental | Other: combine physical training and motor imagery with action observationThe subjects will perform the exercise mentally with video for 1 set and physically with supervision of investigator for 2 sets, 3 sets totally, 10 reps for 1 set. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- without pain or symptoms on lower extremities or spine which affects on daily activities or sports participants lasting for more than 1 week within 6 months.
Key exclusion criteria (4 listed)
- any symptoms or surgery history on lumbar or lower extremities in the past 6 months and still interrupt daily activities or sports participants.
- any neurological or psychosocial disease affects on motor imagery ability.
- with drug or alcohol abuse history.
- with visual or vestibular abnormalities without correction, or with concussion history within 3 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor imagery with action observationStanding clamshell exercise with elastic band, sliding, and Romanian deadlift exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, the subjects will mentally simulate each exercise with video 10 times for a set, 3 sets totally. With 2 min interval between each sets, it will take approximately 8 minutes to finish each movement. It will also take 3 min for resting between each program. | Other | motor imagery with action observation |
| physical trainingStanding clamshell exercise with elastic band, sliding, and Romanian deadlift exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, the subjects will physically perform each exercise with supervision of investigator 10 times for a set, 3 sets totally. With 2 min interval between each sets, it will take approximately 8 minutes to finish each movement. It will also take 3 min for resting between each program. | Other | physical training |
| combine physical training and motor imagery with action observationStanding clamshell exercise with elastic band, sliding, and Romanian deadlift exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, each exercises will be mentally simulated with video for a set and physically performed with supervision of investigator for 2 sets, 10 times for each set and 3 sets totally. With 2 min interval between each sets, it will take approximately 8 minutes to finish each movement. It will also take 3 min for resting between each program. | Other | combine physical training and motor imagery with action observation |
Primary outcome
Motor control ability
Time frame: pre-intervention
The subjects will stand on Y-balance kit with their dominant leg and reach their non-dominant legs to anterior, posterolateral and posteromedial direction following the tempo with 5 sec forward and 5 sec backward in sequence. The subjects will practice 4 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subjects' lower limb length for statistical analysis.
Cortico-muscular coherence
Time frame: pre-intervention
The investigator will place 64-leads EEG on subjects' head and bipolar surface EMG(MP150, BIONOMADIX; BIOPAC, Systems, Inc.) on subjects' internal oblique abdominis, gluteus medius, gluteal maximus and adductor longus. The investigator will collect the signals and process them into cortico-muscular coherence as the functional connection between cortex and muscle during motor control task.
Task-related spectral power
Time frame: immediately after the intervention
The investigator will collect the EEG signals from subjects during the intervention, and the signals will be band-pass filtered (3-60 Hz) and processed with power spectrum density analysis to calculate frequency power at alpha (8-12 Hz) and beta (13-30 Hz) bands. The training data will be normalized with resting values to determine task-related synchronization or desynchronization, which represent the cortical activation changes during training.
Motor control ability
Time frame: immediately after the intervention
The subjects will stand on Y-balance kit with their dominant leg and reach their non-dominant legs to anterior, posterolateral and posteromedial direction following the tempo with 5 sec forward and 5 sec backward in sequence. The subjects will practice 4 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subjects' lower limb length for statistical analysis.
Cortico-muscular coherence
Time frame: immediately after the intervention
The investigator will place 64-leads EEG on subjects' head and bipolar surface EMG(MP150, BIONOMADIX; BIOPAC, Systems, Inc.) on subjects' internal oblique abdominis, gluteus medius, gluteal maximus and adductor longus. The investigator will collect the signals and process them into cortico-muscular coherence as the functional connection between cortex and muscle during motor control task.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Fen Shih, Ph.D study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor imagery with action observation, physical training and combine physical training and motor imagery with action observation in people with Biomechanical Phenomena, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor control ability (time frame: pre-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.