UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028576 |
|---|---|
| Receipt number | R000032624 |
| Scientific Title | Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2024/08/13 11:04:15 |
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Basic information
Public title
Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE
Acronym
Effects of a hip extension movement assist on the gait of stroke
Scientific Title
Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE
Scientific Title:Acronym
Effects of a hip extension movement assist on the gait of stroke
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the influence on hip flexion moment by implementing the hip joint extension movement assist on the affected side in stance phase to stroke patients with ACSIVE walking support equipment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hip joint moment with or without ACSIVE during gait.
Key secondary outcomes
Hip joint angle with or without ACSIVE during gait.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Put the marker on the shoulder, pelvis, and joint of the lower limbs on both side and walk with the walking course with the floor reaction force gauge with comfortable walking speed with or without ACSIVE. Measure the state of walking simultaneously with four video cameras. The required time is about 45 minutes.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Users of Nagoya city Rehabilitation center with ability to walk independently in indoors.
Key exclusion criteria
Those who can not understand the explanation of the research by reason of severe cognitive impairment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ishiguro |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Physical Therapy
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Physical@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ishiguro |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Physical Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
Physical@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suzuka University of Medical Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.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
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jspo/36/2/36_146/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jspo/36/2/36_146/_pdf/-char/ja
Number of participants that the trial has enrolled
12
Results
The median hip flexion angle during initial ground contact decreased significantly from 17.7[deg] to 15.8[deg], and the median maximum hip extension angle during stance phase increased significantly from 11.0[deg] to 15.6[deg].
The median maximum hip extension moment during the load response phase significantly decreased from 0.62 [Nm/kg] to 0.50 [Nm/kg], and the maximum hip flexion moment during the stance phase significantly increased from 0.27 [Nm/kg] to 0.59 [Nm/kg].
Results date posted
| 2024 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were 12 male hemiplegics (mean age 47.4 years) with an average duration of 10.1 months who were able to walk independently indoors on level ground.
Brunnstrom recovery stage was III in 4 patients, IV in 5 patients, and V in 3 patients.
All patients used short-limb orthoses and had no dorsiflexion-limiting joints.
Participant flow
No one dropped out at each stage.
Adverse events
None
Outcome measures
The hip flexion angle at initial ground contact was compared to the maximum hip extension angle during stance phase, and the maximum joint extension moment during the load response phase to the maximum hip flexion moment during stance phase.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032624
