UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007784 |
|---|---|
| Receipt number | R000009172 |
| Scientific Title | Clinical feasibility of mirror therapy combined with electromyography-triggered neuromuscular stimulation for paretic hand after stroke: a pilot randomized crossover trial. |
| Date of disclosure of the study information | 2012/04/18 |
| Last modified on | 2014/04/18 23:09:50 |
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Basic information
Public title
Clinical feasibility of mirror therapy combined with electromyography-triggered neuromuscular stimulation for paretic hand after stroke: a pilot randomized crossover trial.
Acronym
Mirror therapy combined with electromyography-triggered neuromuscular stimulation for paretic hand after stroke.
Scientific Title
Clinical feasibility of mirror therapy combined with electromyography-triggered neuromuscular stimulation for paretic hand after stroke: a pilot randomized crossover trial.
Scientific Title:Acronym
Mirror therapy combined with electromyography-triggered neuromuscular stimulation for paretic hand after stroke.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this early-phase, pilot randomized clinical trial was to investigate the feasibility and possible effects of mirror therapy combined with electromyography-triggered neuromuscular stimulation on upper extremity impairment and activery limitation of the stroke patients during inpatient rehabilitation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Upper extremity items of Fugl-Meyer motor assessment scale
Key secondary outcomes
Active range of motion of wrist extension, Hand ratio, Box and Block Test, Wolf Motor Function Test, Motor Activity Log
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
mirror therapy combined with electromyography-triggered neuromuscular stimulation (two 20 minute sessions per day, 5 days a week for 4 weeks)
Interventions/Control_2
Conventional physical and occupational therapy (2 hours per day, 5 days a week, for 4 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemiparesis caused by single stroke between 30 and 180 days prior to study enrollment, normal consciousness with stable medical and neurological status, Mini Mental State Examination score of > 20, palpable contraction of the wrist and finger extensor muscles of the paretic hand and detectable EMG signal (< 5µV) from those muscles.
Key exclusion criteria
a cardiac pacemaker, serious contractures or pain of shoulder, elbow or wrist joint, shoulder subluxation, severe cognitive impairments or severe aphasia, inability to give informed consent form.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosuke Kojima |
Organization
Nishiyamato Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
kosuke0107@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Kojima |
Organization
Nishiyamato Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Homepage URL
kosuke0107@hotmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hannna Central Hospital
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
西大和リハビリテーション病院（奈良県）、阪奈中央病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 18 | 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
In the first 4 weeks, the immediate ETMS-MT group showed significant greater gain on FMA (p = .003) compared to the delayed ETMS-MT group. In the latter 4 weeks, the delayed ETMS-MT group showed significant greater gain on A-ROM (p = 0.009) compared to the immediate ETMS-MT group. For the immediate ETMS-MT group, significant within-group improvements on FMA (p = 0.04), HR (p = 0.03), WMFT-time (p = 0.03) were seen between T0 and T1 measurement. For the delayed ETMS-MT group, significant within-group improvements on FMA (p = 0.03), A-ROM (p = 0.04), WMFT-time (p = 0.03) and WMFT-FAS (p = 0.03) were seen between T1 and T2 measurement.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 18 | Day |
Last modified on
| 2014 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009172
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| Registered date | File name |
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