Effects of the Insole on Balance Capacity in Chronic Stroke

March 11, 2019 updated by: Taipei Medical University WanFang Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taipei City
      • Taipei, Taipei City, Taiwan
        • Wang Fang hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: insole
The subjects are randomly assigned to assess balance capacity either with or without insole.
Sham Comparator: 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.
Other: insole
The subjects are randomly assigned to assess balance capacity either with or without insole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Berg balance scale from pre to post-intervention.
Time Frame: up to 30 minutes.
The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.
up to 30 minutes.
Change in Functional Reach Test(FRT) from pre to post-intervention.
Time Frame: up to 10 minutes.
The Functional Reach Test (FRT) is a quick screen for determining risk for falls.
up to 10 minutes.
Change in Timed Up and Go (TUG) Test from pre to post-intervention.
Time Frame: up to 10 minutes.
Timed Up and Go (TUG) Test was developed to assess mobility.
up to 10 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Center of pressure (CoP) from pre to post-intervention.
Time Frame: up to 30 minutes.
The center of pressure (CoP) measures derived from the foot pressure mat and force plate of Biodex Balance system.
up to 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Chair: YenTing LIU, Master, Wang Fang Hospital, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 25, 2018

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201705003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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