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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030102
Receipt No. 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 2019/03/28

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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. Walking speed of 0.1 to 1 m/s; 5. Spasticity of at least 1+ on the modified Ashworth scale in the ankle plantar flexor muscle.
Key exclusion criteria 1. Passive ankle dorsiflexion range of motion at 0 or lower; 2. Higher brain dysfunction that presents problems for intervention and/or evaluation; 3. Cardiovascular disease that restricts exercise; 4. 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
Email 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
Email k.fujita-fchs@kvj.biglobe.ne.jp

Sponsor
Institute Fukui Health Science University
Institute
Department

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
Email

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
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.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


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