Effects of the Insole on Balance Capacity in Chronic Stroke

Study Overview
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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.

Official Title
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Effects of the Insole on Balance Capacity in Chronic Stroke

Conditions
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Stroke, Cardiovascular

Intervention / Treatment
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* Other: insole


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chronic stroke patient with insole<br>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<br>* The subjects are randomly assigned to assess balance capacity either with or without insole.<br>|
| Sham Comparator: chronic stroke patient without insole<br>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<br>* The subjects are randomly assigned to assess balance capacity either with or without insole.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, balance, insole