UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045939 |
|---|---|
| Receipt number | R000052389 |
| Scientific Title | Effect of gait training with a knee immobilization device on the trailing limb angle in hemiparetic stroke patients |
| Date of disclosure of the study information | 2021/11/02 |
| Last modified on | 2023/07/05 23:57:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of gait training with a knee immobilization device on the trailing limb angle in hemiparetic stroke patients
Acronym
Gait study for stroke patients
Scientific Title
Effect of gait training with a knee immobilization device on the trailing limb angle in hemiparetic stroke patients
Scientific Title:Acronym
Gait study for stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of gait training with a knee immobilization device on the paralyzed side trailing limb angle in hemiplegic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trailing limb angle before and after three weeks of walking practice
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: Gait practice with the paralyzed side of the knee joint fixed in the extended position using a lower limb orthosis for 30 minutes a day for 3 weeks.
Interventions/Control_2
Control group: Patients will practice normal walking at a comfortable walking speed for 30 minutes a day for 3 weeks, wearing ordinary shoes without fixing the knee joint with a lower limb orthosis. At that time, if the physiotherapist in charge visually judges that the paralyzed leg is hindered by foot pinching during the swing phase, a short leg orthosis will be worn.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemiplegia due to stroke
The motor function of the lower limb is V or lower on the Brunnstrom Recovery Stage (obvious paralysis).
The patient's pre-disease walking ability is 4 or higher on the Functional Ambulation Category (capable of independent walking).
Able to walk more than 5 meters continuously without assistance (use of braces or cane is allowed)
Persons who maintain the range of motion of the ankle dorsiflexion joint in the knee extension position(angle of 0 degrees or more) and the range of motion of the hip joint extension joint (angle of 5 degrees or more)
Key exclusion criteria
Patients with impaired consciousness or higher brain dysfunction that is difficult to measure with electromyography or motion analysis equipment (e.g., hemispatial neglect, attention disorder, aphasia, mental disorder)
Patients with severe vision loss, visual field impairment, or vertigo
Those who have a history of other neurological, respiratory, circulatory, or orthopedic diseases that may affect walking
Translated with www.DeepL.com/Translator (free version)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | IZUMI |
Organization
Tohoku University School of medicine
Division name
Physical Medicine and Rehabilitation
Zip code
980-8574
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7338
izumis@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University School of medicine
Division name
Physical Medicine and Rehabilitation
Zip code
980-8574
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7338
Homepage URL
ito.shun.t1@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University School of medicine Physical Medicine and Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kohnan Hospital Sendai Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-7338
ito.shun.t1@dc.tohoku.ac.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
| 2021 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
We are currently reviewing journals for submission and have not published. We are also not presentin
Publication of results
Unpublished
Result
URL related to results and publications
We are currently reviewing journals for submission and have not published. We are also not presentin
Number of participants that the trial has enrolled
34
Results
We compared the effects of walking training with and without using KO on TLA. As a result, the KO group increased TLA more than the no-KO group.
Results date posted
| 2023 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were 34 hemiplegic stroke patients who met the selection criteria among those who were admitted to the research facility from October 2021 to April 2022 and underwent physical therapy. Patients with acute onset ischemic or hemorrhagic stroke confirmed by CT or MRI, those who can walk 5m independently (whether using a cane or braces for upper and lower legs), lower extremity paralysis ( Brunnstrom convalescence: BRS V or lower)), functional walking category (FAC) before illness: 4 or higher (able to walk independently), knee extension Participants were defined as those who maintained ankle dorsiflexion range of motion (0 or more) and those who maintained hip extension range of motion (5 or more).Persons with cognitive dysfunction and higher brain dysfunction (unilateral spatial neglect, attention disorder, aphasia, mental disorder), severe visual impairment, visual field disorder, dizziness, other neurological diseases, respiratory and cardiovascular diseases , Those with a history of orthopedic diseases were evaluated from the subjects.
Participant flow
Thirty-four hemiplegic stroke survivors met the selection criteria. Of the 34 subjects, 29 (13 in the intervention group and 16 in the control group) were finally eligible for the intervention. The reason for dropping out of the study was that all five subjects had difficulty walking safely during the three-dimensional movement measurement on the first evaluation day.
Adverse events
None
Outcome measures
Changes in TLA of the KO group at the time of Initial assessment day. The one-way ANOVA for TLA showed a significant main effect of time (F= 15.53, p<0.01). Post-hoc pairwise Bonferroni-adjusted comparisons showed a significant difference in TLA between pre vs. during (p<0.01), pre vs. post (p<0.01).
Changes in TLA of the no-KO group at the time of Initial assessment day.
The one-way ANOVA for TLA not showed a significant main effect (F= 0.17, p=0.84).
Changes in TLA between the two groups during the 3-week intervention.
Results of two-way ANOVA showed a main effect for time (F=64.5, p<0.01) and significant interaction between time and group (F=15.4, p<0.01).
Change in comfortable walking speed between the two groups
Results of two-way ANOVA showed a main effect for time (F=33.6, p<0.01).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052389
