Effects of the Insole on Balance Capacity in Chronic Stroke

NCT03194282 | Completed

• 1 other identifier: N201705003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Cardiovascular

Keywords

stroke; balance; insole

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Center of pressure (CoP) from pre to post-intervention.

  up to 30 minutes.

Study Arms (2)

chronic stroke patient with insole

EXPERIMENTAL

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

chronic stroke patient without insole

SHAM COMPARATOR

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

Interventions

insole OTHER

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

chronic stroke patient with insole; chronic stroke patient without insole

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- A diagnosis of other neurological or musculoskeletal disorders that could affect postural balance.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wang Fang hospital

Taipei, Taipei City, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 24259792 BACKGROUND

• 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.

  PMID: 24600215 BACKGROUND

• 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.

  PMID: 19070493 BACKGROUND

• 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.

  PMID: 33894465 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Stroke

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• YENTING LIU, Master

  Wang Fang Hospital, Taipei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 21, 2017
• Study Start: July 27, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 25, 2018
• Last Updated: March 13, 2019

Record last verified: 2018-05

Locations

TW (1)