Clinical trial NCT03194282: Effects of the Insole on Balance Capacity in Chronic Stroke
Official title: Effects of the Insole on Balance Capacity in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Cardiovascular
Keywords: stroke
balance
insole
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Berg balance scale from pre to post-intervention.
timeFrame: up to 30 minutes.
measure: Change in Functional Reach Test(FRT) from pre to post-intervention.
timeFrame: up to 10 minutes.
measure: Change in Timed Up and Go (TUG) Test from pre to post-intervention.
timeFrame: up to 10 minutes.
Secondary outcomes:
measure: Change in Center of pressure (CoP) from pre to post-intervention.
timeFrame: up to 30 minutes.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wang Fang hospital
state: Taipei City
Study officials:
affiliation: Wang Fang Hospital, Taipei Medical University
name: YENTING LIU, Master
role: STUDY_CHAIR
References:
citation: Christovao 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.
citation: 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.
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.
citation: Liu YT, Tsai HT, Hsu CY, Lin YN. Effects of orthopedic insoles on postural balance in patients with chronic stroke: A randomized crossover study. Gait Posture. 2021 Jun;87:75-80. doi: 10.1016/j.gaitpost.2021.04.014. Epub 2021 Apr 20.