UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054741 |
|---|---|
| Receipt number | R000062467 |
| Scientific Title | Development of the upper limb motor training that facilitates compensatory neural pathways after brain and spinal cord lesions: a pilot study |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/12/24 09:45:21 |
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Basic information
Public title
Development of motor training after brain and spinal cord lesions
Acronym
Motor training after brain and spinal cord lesions
Scientific Title
Development of the upper limb motor training that facilitates compensatory neural pathways after brain and spinal cord lesions: a pilot study
Scientific Title:Acronym
Motor training after brain and spinal cord lesions
Region
| Japan |
Condition
Condition
Cerebral Infarction
Traumatic Spinal Cord Injury
Spinal Cord Infarction
Cervical Spondylotic Myelopathy
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate neurophysiological changes after the short-term upper limb motor training in individuals with and without chronic brain or spinal cord lesion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitudes of motor-evoked potentials at the end of intervention
Key secondary outcomes
Amplitudes of somatosensory-evoked potentials at the end of intervention
Electroencephalogram-electromyogram coherence at the end of intervention
Electromyogram-electromyogram coherence at the end of intervention
Action Research Arm Test score at the end of intervention
The Graded Redefined Assessment of Strength, Sensibility and Prehension score at the end of intervention
Upper extremity motor score of the international standards for neurological classification of spinal cord injury at the end of intervention
Maximum grip strength at the end of intervention
Maximum pinch strength at the end of intervention
Kinematics of the upper limb during prehension movements at the end of intervention
Fingertip forces during prehension movements at the end of intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Upper limb reaching exercise for 5 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Criteria for healthy participants:
[1] Person who is between 18 and 85 years old
[2] Person without history of upper motor impairments due to neurological or musculoskeletal diseases
[3] Person who is right-handed
Criteria for patients:
[1] Person who is between 18 and 85 years old
[2] Person who has been diagnosed as cerebral infarction, traumatic cervical spinal cord injury, spinal cord infarction, or cervical spondylotic myelopathy, and shows upper motor neuron sign(s)
[3] Person without progression of symptoms more than 6 months after onset or decompression surgeries
[4] Person who is able to reach out and grasp a 5 cm square object 30 cm away from the body
Key exclusion criteria
[1] Person who has uncontrolled medical conditions (severe heart failure, respiratory failure, diabetes mellitus, hypertension, interstitial pneumonia, kidney failure, autoimmune disease, neoplastic disease, psychiatric disease, infection, or dementia)
[2] Person who needs respiratory management with ventilators
[3] Person who has intracranial metallic or magnetic pieces, or pacemakers
[4] Person who has implantable medical devices, person with history of seizures or epilepsy, person who takes medications, which could lower threshold for seizures (e.g. TCAs, neuroleptic agents), person who is suffering from drug abuse or withdrawal symptoms, person who is pregnant
[5] Person who is considered inappropriate to become a participant by a physician
[6] Person who has participated in other clinical studies within 12 weeks and has taken medication in the studies
[7] Person who is participating in other clinical studies
[8] Person who is a minor
[9] Person without sufficient comprehension and judgement due to disease or disability even if the person is a major
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Suzuki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
shinya-suzuki@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Suzuki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
shinya-suzuki@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062467
