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Completed

NCT Number: NCT03194282

Effects of the Insole on Balance Capacity in Chronic Stroke

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.

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Key information

Conditions

Stroke, Cardiovascular Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wang Fang hospital

Taipei, Taipei City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insole

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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