UMIN-CTR Clinical Trial

Public title

Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair

Acronym

Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair

Scientific Title

Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair

Scientific Title:Acronym

Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair

Region

Japan

Condition

Hip Fracture

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

ADL (Barthel Index): at 2 weeks, 6 months, 9 months, and 1 year after surgery

Key secondary outcomes

nursing care level: at 1 year after surgery

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Standard rehabilitation program using walker with weight bearing lift. The estimated period of use: starting from an early stage after surgery to discharge from acute hospital(maximum), frequency: one time (10-20 minutes)). Rehabilitation program are generally based on clinical path adapted in each hospital. Lead principal investigator is not involved in minor change of program and clinical path.

Interventions/Control_2

Standard rehabilitation program. Conventional walker owned in the hospital is used in walking training. Rehabilitation program are generally based on clinical path adapted in each hospital. Lead principal investigator is not involved in minor change of program and clinical path.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)fractured the proximal part of their femur
2)underwent a surgery, such as a femoral head replacement
3)degree of independent daily living for the disabled elderly of J or A
4)independent daily living score for the demented elderly of 1 or 2

Key exclusion criteria

1)the existence of hip fracture on the opposite side
2)multiple fractures
3)no permit for weight bearing immediately after surgery
4)pathological fracture

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Ryo Tanaka

Organization

Hiroshima International University

Division name

Department of Rehabilitation, Faculty of Rehabilitation

Zip code

Address

555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima

TEL

0823-70-4914

Email

r-tanaka@hs.hirokoku-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ryo Tanaka

Organization

Hiroshima International University

Division name

Department of Rehabilitation, Faculty of Rehabilitation

Zip code

Address

555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima

TEL

0823-70-4914

Homepage URL

Email

r-tanaka@hs.hirokoku-u.ac.jp

Institute

Hiroshima International University

Institute

Department

Personal name

Organization

MHLW(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

09

Month

03

Day

Date of IRB

2015

Year

11

Month

18

Day

Anticipated trial start date

2015

Year

09

Month

04

Day

Last follow-up date

2017

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Recruitment is performed between September 2015 and March 2017. Patients are selected only who provide written informed consent. Measurement items include pre-rehabilitation baseline data (age, sex, gait method, place of residence, ADL level, nursing care level, type of fracture, and surgical method). ADL disabilities, Chair-stand-30 (CS-30) test results, and pain intensity at 2 weeks after surgery are also included. The data of ADL level and nursing care level are collected by 1 year after surgery. In this study, the data of our observational study "Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair" (UMIN000022216) are also used.

Registered date

2016

Year

05

Month

31

Day

Last modified on

2023

Year

12

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025515