Effects of the Insole on Balance Capacity in Chronic Stroke

Stroke, Cardiovascular Clinical Trial

Official title:

Effects of the Insole on Balance Capacity in Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194282
• Other study ID #: N201705003
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: May 2018
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 25, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Infarction
• Stroke
• Stroke, Cardiovascular

Intervention

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

Locations

Country	Name	City	State
Taiwan	Wang Fang hospital	Taipei	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

Christovão 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.