UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027930
Receipt number R000031994
Scientific Title Effects of the lateral movement training with wedge on the SPV and the sitting balance for cerebrovascular accident patients in recovery phase.
Date of disclosure of the study information 2017/06/25
Last modified on 2022/04/17 16:31:23

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Basic information

Public title

Effects of the lateral movement training with wedge on the SPV and the sitting balance for cerebrovascular accident patients in recovery phase.

Acronym

Effects of the adaptation on patients with cerebrovascular accidents.

Scientific Title

Effects of the lateral movement training with wedge on the SPV and the sitting balance for cerebrovascular accident patients in recovery phase.

Scientific Title:Acronym

Effects of the adaptation on patients with cerebrovascular accidents.

Region

Japan


Condition

Condition

cerebrovascular accident

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clearly effects of the maximum lateral movement training with wedge on sitting on SPV, sitting balance and trunk functions in cerebrovascular accident patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Subjective Postural Vertical(Eyes-open, Eyes-closed)

Key secondary outcomes

Trunk Impairment Scale
Trunk Righting Test
Sitting pressure


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Maximum lateral movement training with wedge. In the training method, a wedge was placed on paretic side of the ischial with or without a wedge. The specific training was a body tilted toward the wedge side in the wedge condition. We performed the intervention using the maximum tilting toward the wedge side in the training environment. The original training required inclining the trunk laterally to the paretic side to the maximum possible, while balanced to the wedge side, and repeating this movement in 2 min at 60 times. Patient instructions were as follows. Tilt your trunk maximum to the right or left as far as you can after my signal. These efforts were repeated 60 times. The vertically cognitive measurements were performed afterward. In the training protocol, we measured with or without a wedge condition counterpart in both pre- and post-training environments, as an evaluation at random immediately, and for each 14 days.

Interventions/Control_2

The control condition was performed using similar maximum lateral truncal tilt balance training to the paretic side without a wedge. In the training method, a wedge was placed on paretic side of the ischial without a wedge.

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

Cerebro vascular patients in Takenostuka-nousinnkei rehabilitation hospital.

Key exclusion criteria

Brain stem, cerebellar lesion, multiple cerebral infarction, cerebral ventricle, hydrocephalus etc. Poor instruction comprehension understanding person, person with difficulty in measuring position, person with orthopedic history.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kota
Middle name
Last name Sawa

Organization

Department of Takenostuka-Noushinkei Rehabilitation Hospital
Tokyo Metropolitan University, Graduate School of Human Health Sciences

Division name

Rehabilitation

Zip code

121-0064

Address

Nishihokima, 1-21-7, Paru-mu Hutte, 103, Tokyo, Japan

TEL

080-1207-9205

Email

koutas966@gmail.com


Public contact

Name of contact person

1st name Kota
Middle name
Last name Sawa

Organization

Department of Takenostuka-Noushinkei Rehabilitation Hospital Tokyo Metropolitan University, Graduate

Division name

Rehabilitation

Zip code

121-0064

Address

Nishihokima, 1-21-7, Paru-mu Hutte, 103, Tokyo, Japan

TEL

080-1207-9205

Homepage URL


Email

koutas966@gmail.com


Sponsor or person

Institute

Department of Rehabilitation, Takenostuka Noshinkei Rehabilitation Hospital
Department of Physiotherapy, Graduate School of Human Health Sciences, Tokyo Metropolitan University

Institute

Department

Personal name



Funding Source

Organization

Department of Rehabilitation, Takenostuka Noshinkei Rehabilitation Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Takenotsuka Noshinkei Rehabilitation

Address

Adachi-ku, Hokima 4-15-16, Tokyo, Japan

Tel

03-5851-1108

Email

koutas966@gmail.com


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

竹の塚脳神経リハビリテーション病院(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 25 Day


Related information

URL releasing protocol

https://content.iospress.com/articles/neurorehabilitation/nre210255

Publication of results

Unpublished


Result

URL related to results and publications

https://content.iospress.com/articles/neurorehabilitation/nre210255

Number of participants that the trial has enrolled

33

Results

There was no interaction between the control condition and SPV or SPV-EO directional errors. SPV variability showed an interaction between time and wedge condition with 1.6 as the minimal clinically important difference (MCID).

Results date posted

2022 Year 04 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 03 Month 31 Day

Baseline Characteristics

The patient was admitted to a convalescent hospital and was assumed to be a patient with a first cerebrovascular accident.

Participant flow

This study included 855 patients admitted between March 2018 to April 2020. Of these, 33 met the inclusion criteria of being able to sit when observing a person and having suffered their first stroke.

Adverse events

Did not receive allocated intervention (injured upper limb in ADL, n = 1)

Outcome measures

Patient demographics were collected from medical records, including age, sex, number of days from onset to measurement, diagnosis, injury hemisphere, injury site, Brunnstrom Recovery Stage (BRS) (Brunnstrom et al., 1970), and Stroke Impairment Assessment Set (Liu et al., 2002). BRS is an index that evaluates voluntary paralysis in the upper limb, finger, and lower limb according to six levels from I to VI. SIAS is a stroke functional disability assessment that evaluates 22 items in 9 categories on a 76-point scale. The higher the score, the milder the functional impairment, and the lower the score, the more severe the impairment.
It is useful for assessing multifaceted functional disabilities such as range of motion, muscle strength, muscle tone, sensation, pain, balance, and higher brain dysfunction.
The primary outcomes were SPV and SPV-EO, and the secondary outcomes were the total Functional Independence Measure (FIM) score and the transfer items in FIM.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 06 Month 25 Day

Date of IRB

2016 Year 09 Month 10 Day

Anticipated trial start date

2017 Year 06 Month 25 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 25 Day

Last modified on

2022 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031994


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name