Effects of the Insole on Balance Capacity in Chronic Stroke

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03194282

Enrollment

Registered

2017-06-21

Start date

2017-07-27

Completion date

2018-06-25

Last updated

2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Cardiovascular

Keywords

stroke, balance, insole

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.

Interventions

OTHERinsole

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026