UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044300 |
|---|---|
| Receipt number | R000043951 |
| Scientific Title | Efficacy of repetitive lateral truncal tilt balance training with a wedge on subjective postural vertical recovery after stroke -A randomized crossover trial- |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2023/04/02 09:48:35 |
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Basic information
Public title
Efficacy of repetitive lateral truncal tilt balance training with a wedge on subjective postural vertical recovery after stroke
-A randomized crossover trial-
Acronym
Efficacy of repetitive lateral truncal tilt balance training with a wedge on subjective postural vertical recovery after stroke
-A randomized crossover trial-
Scientific Title
Efficacy of repetitive lateral truncal tilt balance training with a wedge on subjective postural vertical recovery after stroke
-A randomized crossover trial-
Scientific Title:Acronym
Efficacy of repetitive lateral truncal tilt balance training with a wedge on subjective postural vertical recovery after stroke
-A randomized crossover trial-
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The porpose of this study is to clarify the effect of repetitive lateral truncal tilt balance training with a wedge on subjective postual vertical, balance and recovery in patients after stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective postual vertical
Key secondary outcomes
FBS
FIST
TCT
FIM
SIAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
There were 14-day intervention periods for the wedge (WC); moreover, there were 3-day washout periods.
Interventions/Control_2
There were 14-day intervention periods for control conditions (CC); moreover, there were 3-day washout periods.
Interventions/Control_3
The training comprised lateral trunk tilt training with and without a 10 degrees wedge inserted under the paretic side of the ischial area.
Interventions/Control_4
Based on the participant's prior condition, they were randomly assigned to either the WG or CG.
Participants in the WG underwent eyes-closed maximal lateral truncal tilt training toward the paretic side. Contrastingly, participants in the CG underwent training without the wedge. When participants in the WG performed the training at 0.25 Hz, they did not float the ischial on the non-paretic side.
Interventions/Control_5
The participants were allowed to sufficiently practice the task as follows: immediately after the signal, they were asked to maximally lean their body to the right (or left) and maintain the posture, with the procedure being repeated with or without the wedge 60 times.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
first stroke
Key exclusion criteria
non hear person
both atacked lesion
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
Department of Rehabilitation, Takenotsuka Noshinkei Rehabilitation Hospital.
Department of Physiotherapy, Graduate School of Human Health Sciences, Tokyo Metropolitan University.
Division name
Rehabilitation
Zip code
121-0064
Address
Adachi-ku, Hokima, 4-15-16, Tokyo, Japan
TEL
03-5851-1108
koutas966@gmail.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
Department of Rehabilitation, Takenotsuka Noshinkei Rehabilitation Hospital.
Division name
Rehabilitation
Zip code
121-0064
Address
Adachi-ku, Hokima, 4-15-16, Tokyo, Japan
TEL
03-5851-1108
Homepage URL
koutas966@gmail.com
Sponsor or person
Institute
Department of Rehabilitation, Takenotsuka Noshinkei Rehabilitation Hospital.
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation, Takenotsuka Noshinkei Rehabilitation Hospital.
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
Department of Rehabilitation, Takenotsuka Noshinkei Rehabilitation Hospital.
Address
Adachi-ku, Hokima 4-15-16, Tokyo, Japan
Tel
03-5851-1108
koutas966@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
89
Org. issuing International ID_1
Sonoda ethics committees
Study ID_2
19022
Org. issuing International ID_2
Tokyo Metropolitan University
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://content.iospress.com/articles/neurorehabilitation/nre210255
Publication of results
Published
Result
URL related to results and publications
https://content.iospress.com/articles/neurorehabilitation/nre210255
Number of participants that the trial has enrolled
34
Results
SPV and SPV-EO variability showed an interaction between time and wedge condition (p = 0.00) and (p= 0.00), respectively.
There was an interaction between time and wedge condition (p= 0.000), as well as a simple main effect of time (pre-post 1, pre-post 2) (p= 0.000) in FIM.
Results date posted
| 2021 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no between-group differences in age, days since onset, paretic limb severity, and unilateral spatial neglect (USN) symptom severity.
Participant flow
Group allocation was performed using the permuted block method. The training condition was randomly assigned to the wedge (WG) and control group (CG).
Blinding was performed by a data measurer/evaluator after intervention allocation.
Adverse events
Nothing
Outcome measures
SPV and SPV-EO were measured at the point where each participant considered as vertical from their trunk line. The participants sat on the device and inclined 15 degrees to 20 degrees to the left or right at 1.5 degrees per second.
SPV and SPV-EO measurements were performed in a randomized order; moreover, the starting direction of tilt measurements was left or right based on the ABBABAAB sequence. The standard deviation of the eight measurements was used as the PV tilt variability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043951
