UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033187 |
|---|---|
| Receipt number | R000037586 |
| Scientific Title | The influence of walking speed on lower-limb muscle activity during manual-assisted gait using a knee-ankle-foot orthosis in stroke patients with severe hemiparesis |
| Date of disclosure of the study information | 2018/06/29 |
| Last modified on | 2023/07/26 20:42:42 |
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Basic information
Public title
The influence of walking speed on lower-limb muscle activity during manual-assisted gait using a knee-ankle-foot orthosis in stroke patients with severe hemiparesis
Acronym
The influence of walking speed on muscle activity in hemiparetic gait using a knee-ankle-foot orthosis
Scientific Title
The influence of walking speed on lower-limb muscle activity during manual-assisted gait using a knee-ankle-foot orthosis in stroke patients with severe hemiparesis
Scientific Title:Acronym
The influence of walking speed on muscle activity in hemiparetic gait using a knee-ankle-foot orthosis
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influences of walking speedon lower-limb muscle atitivities during manual-assisted gait using a knee-ankle-foot orthosis in stroke patients with severe hemiparesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activities in gluteus medius, rectus femoris, semitendinosus, tibialis anterior, and medial gastrocnemius on the paretic side during gait
Key secondary outcomes
Spatiotemporal gait parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Manual-assisted gait training using a knee-ankle-foot orthosis with a metronome pace of 120 bpm
Interventions/Control_2
Manual-assisted gait training using a knee-ankle-foot orthosis with a metronome pace of 96 bpm
Interventions/Control_3
Manual-assisted gait training using a knee-ankle-foot orthosis with a metronome pace of 72 bpm
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) First-ever unilateral supratentorial stroke undergoing inpatient rehabilitation
2) Medically stable condition
3) Required continuous physical-assistance during ambulation (the Functional Ambulation Categories <=1)
4) Severe weakness of the paretic lower-extremity (the Motricity Index score <=29)
Key exclusion criteria
1) Symptomatic cardiac, musculoskeletal, or neurological conditions other than stroke
2) Unable to understand the instructions because of communication or cognitive problems
3) Moderate-to-severe pushing behavior while manual-assisted walking (the Burke Lateropulsion Scale walking subscore >=2)
4) Disagreement to participate in the study
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Shimizu |
Organization
Fujioka General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
375-8503
Address
813-1 Shimokurisu, Fujioka, Gunma, Japan
TEL
0274-22-3311
rehab-pt@fujioka-hosp.or.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Isho |
Organization
Fujioka General Hospital
Division name
Rehabilitation Center
Zip code
375-8503
Address
813-1 Shimokurisu, Fujioka, Gunma, Japan
TEL
0274-22-3311
Homepage URL
rehab-pt@fujioka-hosp.or.jp
Sponsor or person
Institute
Fujioka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujioka General Hospital
Address
813-1 Shimokurisu, Fujioka, Gunma, Japan
Tel
0274-22-3311
rehab-pt@fujioka-hosp.or.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
| 2018 | Year | 06 | Month | 29 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037586
