Effects of the Insole on Balance Capacity in Chronic Stroke

Not Applicable

Completed

• Conditions: Stroke, Cardiovascular
• Interventions: Other: insole

• Registration Number: NCT03194282
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Study Start: 2017-07-27
• Status Verified: 2018-05
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-25
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
chronic stroke patient with insole	insole	Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.
chronic stroke patient without insole	insole	Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.

Primary Outcome Measures

Name	Time	Method
Change in Timed Up and Go (TUG) Test from pre to post-intervention.	up to 10 minutes.	Timed Up and Go (TUG) Test was developed to assess mobility.
Change in Berg balance scale from pre to post-intervention.	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.
Change in Functional Reach Test(FRT) from pre to post-intervention.	up to 10 minutes.	The Functional Reach Test (FRT) is a quick screen for determining risk for falls.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wang Fang hospital; 🇨🇳 Taipei, Taipei City, Taiwan