- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04861350
Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 2
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 11221
- National Yang Ming University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: motor imagery with action observation
The subjects will perform the exercises mentally for 3 sets with video, 10 reps for 1 set.
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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.
|
|
Experimental: physical training
The subjects will perform the exercise physically for 3 sets with supervision of investigator, 10 reps for 1 set.
|
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.
|
|
Experimental: combine physical training and motor imagery with action observation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
pre-intervention
|
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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.
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pre-intervention
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Task-related spectral power
Time Frame: immediately after the intervention
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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.
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immediately after the intervention
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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.
|
immediately after the intervention
|
|
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.
|
immediately after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yi-Fen Shih, Ph.D, Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YM110027E(2)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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