UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030102 |
|---|---|
| Receipt number | R000034351 |
| Scientific Title | How effective is Physical Therapy for gait muscle activity in hemiparetic patients who received botulinum toxin injections? |
| Date of disclosure of the study information | 2017/11/24 |
| Last modified on | 2020/04/20 15:47:43 |
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Basic information
Public title
How effective is Physical Therapy for gait muscle activity in hemiparetic patients who received botulinum toxin injections?
Acronym
Gait electromyography after BoNT-A
Scientific Title
How effective is Physical Therapy for gait muscle activity in hemiparetic patients who received botulinum toxin injections?
Scientific Title:Acronym
Gait electromyography after BoNT-A
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of physical therapy after botulinum neurotoxin A (BoNT-A) administration on gait electromyography in hemiparetic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait electromyography was performed and gait parameters were measured immediately before and 2 weeks after BoNT-A administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
BoNT-A administration: 300 units
Interventions/Control_2
BoNT-A administration: 300 units
Physical therapy: 2 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Unilateral lesions in the cerebrum; 2. At least 6 months since stroke onset; 3. Walking ability at monitoring level or higher; 4. Spasticity of at least 1+ on the modified Ashworth scale in the ankle plantar flexor muscle.
Key exclusion criteria
1. Higher brain dysfunction that presents problems for intervention and/or evaluation; 2. Cardiovascular disease that restricts exercise; 3. BoNT-A administration within the previous 4 months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Fujita |
Organization
Fukui Health Science University
Division name
Faculty of Health Science, Department of Rehabilitation Physical Therapy
Zip code
Address
Egami 55-13-1, Fukuishi, Fukui, 910-3190, Japan
TEL
0776-59-2200
k.fujita-fchs@kvj.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Fujita |
Organization
Fukui Health Science University
Division name
Faculty of Health Science, Department of Rehabilitation Physical Therapy
Zip code
Address
Egami 55-13-1, Fukuishi, Fukui, 910-3190, Japan
TEL
0776-59-2200
Homepage URL
k.fujita-fchs@kvj.biglobe.ne.jp
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa University, Faculty of Health Science, Institute of Medical, Pharmaceutical and Health Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In this study, marked changes in muscle activity occurred in patients with stroke who had physical therapy after BoNT-A administration to the ankle plantar flexor muscles. These changes were increased biceps femoris activity and increased co-activation indices for the rectus femoris and biceps femoris during the loading-response phase, and increased tibialis anterior activity and decreased triceps surae and rectus femoris activities in the pre-swing and swing phases. Almost all patients in both treatment groups showed improved walking speed, and none reported gait deterioration. Physical therapy after BoNT-A administration increased the stability and leg-swing capability of the knee and could prevent decreased walking ability.
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | 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
| 2017 | Year | 11 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034351
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/20 | Database.xlsx |
