UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033920
Receipt number R000038603
Scientific Title The effect of bracing and exercise therapy in adult spinal deformity
Date of disclosure of the study information 2018/08/29
Last modified on 2020/02/28 21:33:47

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Basic information

Public title

The effect of bracing and exercise therapy in adult spinal deformity

Acronym

The effect of bracing and exercise therapy in adult spinal deformity

Scientific Title

The effect of bracing and exercise therapy in adult spinal deformity

Scientific Title:Acronym

The effect of bracing and exercise therapy in adult spinal deformity

Region

Japan


Condition

Condition

40 patients aged over 50 who complained of postural abnormality and gait disturbance

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Establishment of evidence based conservative treatment for patients with spinal deformity

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of back pain and activity of daily living by self-written questionnaire
Evaluation time; at the start, 3 weeks, 3 months, 6 months

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Rehabilitation

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

50 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

It is a case which was classified as kyphosis by lateral X-rays and the case that a long-time walking is not possible

Key exclusion criteria

It is a case with the gait disturbance for the disease of lower limbs, tumor of spine or lower limbs, neurologic abnormality, the spinal compression fracture of the acute phase, lumbar spinal surgery, the history of the vertebral fracture except the compression fracture

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Toshimi
Middle name
Last name Aizawa

Organization

Tohoku University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

9808574

Address

Seiryo 1-1, Aoba-ku, Sendai, JAPAN

TEL

+81-22-717-7245

Email

onodaworld@hotmail.com


Public contact

Name of contact person

1st name Yoshito
Middle name
Last name Onoda

Organization

Tohoku University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

9808574

Address

Seiryo 1-1, Aoba-ku, Sendai, JAPAN

TEL

+81-22-717-7245

Homepage URL


Email

onodaworld@hotmail.com


Sponsor or person

Institute

Department of Orthopaedic Surgery, Tohoku University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic Surgery, Tohoku University School of Medicine

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

Tohoku University School of Medicine

Address

Seiryo 1-1, Aoba-ku, Sendai, JAPAN

Tel

+81-22-717-7245

Email

onodaworld@hotmail.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



Other administrative information

Date of disclosure of the study information

2018 Year 08 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

Open public recruiting

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2018 Year 07 Month 23 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2023 Year 08 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 08 Month 27 Day

Last modified on

2020 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038603


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name