UMIN-CTR Clinical Trial

Public title

Gait modifications of type 2 diabetes neuropathy patients following task-oriented motor sequence gait trainings

Acronym

Gait training in type 2 diabetes

Scientific Title

Gait modifications of type 2 diabetes neuropathy patients following task-oriented motor sequence gait trainings

Scientific Title:Acronym

Gait training in type 2 diabetes

Region

Asia(except Japan)

Condition

Gait training in type 2 diabetes neuropathy

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

it is unknown whether Task-Oriented (TO) motor sequence gait training with the purpose of promoting timing and coordination would change gait function and biomechanics in Diabetic Neuropathy patients.

Basic objectives2

Others

Basic objectives -Others

If Task-oriented gait training help patients to show any effect on the risk of falling.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gait trainings showed statistically significant increase in second vertical peak force and Propulsive Force despite decrease in the vertical minimum force and breaking force (P>0.05). However, just second vertical peak force, vertical minimum force and propulsive showed significant differences in the pairwise comparisons (P>0.05). There was no significant differences in the first vertical peak force, breaking time and propulsive time after training (P<0.05). Time Get Up and Go significantly decreased while Fall Efficacy Scale-Iinternational reflected significantly increase after gait trainings (P>0.05).

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Task-Oriented motor sequence gait trainings in the present study started with different stepping patterns that progressively changed to complicated patterns of walking. Then after, various walking patterns combined with the activation of the upper extremity and then ended up with treadmill- paced practice. Gait trainings have occurred 24 times, 2 times per week, in between Pre-training and Post-training sessions.

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

Age-lower limit

40

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

Eligible patients had to show mild to moderate level of neuropathy in the Michigan questionnaire and they had to finish Time Get Up and Go test (TGUG) in less than 13 seconds as a scale of walking performance.

Key exclusion criteria

Patients were excluded from this study if they had retinopathy, scares under their feet, hypo or hypertension, autonomic neuropathy or any orthopedic and neurologic disorder that influence walking performance in patients. Also, patients had no experience with similar gait trainings or balance practices.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Hoda Salsabili

Organization

Tarbiat Modares University

Division name

Department of physical Therapy

Zip code

Address

Jalal Al Ahmad Street, Gisha Bridge

TEL

+81-098-21-82883819

Email

hoda.salsabili@modares.ac.ir

Name of contact person

1st name
Middle name
Last name	Hoda Salsabili

Organization

Tarbiat Modares University

Division name

Department of physical Therapy

Zip code

Address

Jalal Al Ahmad Street, Gisha Bridge

TEL

+81-098-21-82883819

Homepage URL

Email

hoda.salsabili@modares.ac.ir

Institute

Hoda Salsabili

Institute

Department

Personal name

Organization

Project extracted from my PhD project.

Organization

Division

Category of Funding Organization

Self funding

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

Tarbiat Modares University

Date of disclosure of the study information

2015

Year

10

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

Gait trainings showed statistically significant increase in second vertical peak force and Propulsive Force despite decrease in the vertical minimum force and breaking force (P>0.05). However, just second vertical peak force, vertical minimum force and propulsive showed significant differences in the pairwise comparisons (P>0.05). There was no significant differences in the first vertical peak force, breaking time and propulsive time after trainings (P<0.05). TGUG significantly decreased while FES-I reflected significantly increase after gait trainings (P>0.05).

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

2014

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

09

Day

Last modified on

2015

Year

09

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021925