Effects of the Insole on Balance Capacity in Chronic Stroke

NCT ID: NCT03194282

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-27

Study Completion Date

2018-06-25

Brief Summary

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Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift body weight or to with stand external pertubations. Postural movement patterns include three discrete control strategies: hip, knee, and ankle strategy. The ankle rocker is an important factor to maintain balance during standing and the ankle strategy restores the center of mass (CoM) to a position of stability through body movement. As a result, effective control of foot motion and ankle stability may decrease postural sway and the risk of fall in chronic stroke.The purpose of this study is to investigate the effects of the insole on balance capacity in chronic stroke.

Detailed Description

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An important determinant of activities of daily living performance is standing balance. Therefore, poor balance, or postural stability, is significant predictors the risk of fall. After a fall, the patient can experience psychological, physical, social, economic, and sometimes fatal effects. The injuries can reduce the patient's mobility as well as independence and influence quality of life.Patients with chronic stroke wearing functional insoles and sham insoles to challenge balance tests.

Conditions

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Stroke, Cardiovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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chronic stroke patient with insole

Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.

Group Type EXPERIMENTAL

insole

Intervention Type OTHER

The subjects are randomly assigned to assess balance capacity either with or without insole.

chronic stroke patient without insole

Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.

Group Type SHAM_COMPARATOR

insole

Intervention Type OTHER

The subjects are randomly assigned to assess balance capacity either with or without insole.

Interventions

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insole

The subjects are randomly assigned to assess balance capacity either with or without insole.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A history of unilateral chronic stroke occurrence over 6 months prior to the study
* Ability to understand verbal instructions.
* Ability to walk 5 meters independently without the need of ankle-foot orthosis.

Exclusion Criteria

\- A diagnosis of other neurological or musculoskeletal disorders that could affect postural balance.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YENTING LIU, Master

Role: STUDY_CHAIR

Wang Fang Hospital, Taipei Medical University

Locations

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Wang Fang hospital

Taipei, Taipei City, Taiwan

Site Status

Countries

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Taiwan

References

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Christovao TC, Neto HP, Grecco LA, Ferreira LA, Franco de Moura RC, Eliege de Souza M, Franco de Oliveira LV, Oliveira CS. Effect of different insoles on postural balance: a systematic review. J Phys Ther Sci. 2013 Oct;25(10):1353-6. doi: 10.1589/jpts.25.1353. Epub 2013 Nov 20.

Reference Type BACKGROUND
PMID: 24259792 (View on PubMed)

Chen TH, Chou LW, Tsai MW, Lo MJ, Kao MJ. Effectiveness of a heel cup with an arch support insole on the standing balance of the elderly. Clin Interv Aging. 2014 Feb 20;9:351-6. doi: 10.2147/CIA.S56268. eCollection 2014.

Reference Type BACKGROUND
PMID: 24600215 (View on PubMed)

Rougier PR, Genthon N. Dynamical assessment of weight-bearing asymmetry during upright quiet stance in humans. Gait Posture. 2009 Apr;29(3):437-43. doi: 10.1016/j.gaitpost.2008.11.001. Epub 2008 Dec 12.

Reference Type BACKGROUND
PMID: 19070493 (View on PubMed)

Liu YT, Tsai HT, Hsu CY, Lin YN. Effects of orthopedic insoles on postural balance in patients with chronic stroke: A randomized crossover study. Gait Posture. 2021 Jun;87:75-80. doi: 10.1016/j.gaitpost.2021.04.014. Epub 2021 Apr 20.

Reference Type DERIVED
PMID: 33894465 (View on PubMed)

Other Identifiers

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N201705003

Identifier Type: -

Identifier Source: org_study_id

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