Back to resultsEffects of the Insole on Balance Capacity in Chronic Stroke
Primary Purpose
Stroke, Cardiovascular
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
insole
Sponsored by
About this trial
This is an interventional screening trial for Stroke, Cardiovascular focused on measuring stroke, balance, insole
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.
Sites / Locations
- Wang Fang hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
chronic stroke patient with insole
chronic stroke patient without insole
Arm Description
Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.
Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.
Outcomes
Primary Outcome Measures
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.
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.
Change in Timed Up and Go (TUG) Test from pre to post-intervention.
Timed Up and Go (TUG) Test was developed to assess mobility.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03194282
First Posted
May 31, 2017
Last Updated
March 11, 2019
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03194282
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular
Keywords
stroke, balance, insole
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chronic stroke patient with insole
Arm Type
Experimental
Arm Description
Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.
Arm Title
chronic stroke patient without insole
Arm Type
Sham Comparator
Arm Description
Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.
Intervention Type
Other
Intervention Name(s)
insole
Intervention Description
The subjects are randomly assigned to assess balance capacity either with or without insole.
Primary Outcome Measure Information:
Title
Change in Berg balance scale from pre to post-intervention.
Description
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.
Time Frame
up to 30 minutes.
Title
Change in Functional Reach Test(FRT) from pre to post-intervention.
Description
The Functional Reach Test (FRT) is a quick screen for determining risk for falls.
Time Frame
up to 10 minutes.
Title
Change in Timed Up and Go (TUG) Test from pre to post-intervention.
Description
Timed Up and Go (TUG) Test was developed to assess mobility.
Time Frame
up to 10 minutes.
Secondary Outcome Measure Information:
Title
Change in Center of pressure (CoP) from pre to post-intervention.
Description
The center of pressure (CoP) measures derived from the foot pressure mat and force plate of Biodex Balance system.
Time Frame
up to 30 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YENTING LIU, Master
Organizational Affiliation
Wang Fang Hospital, Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Wang Fang hospital
City
Taipei
State/Province
Taipei City
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24259792
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.
Results Reference
background
PubMed Identifier
24600215
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.
Results Reference
background
PubMed Identifier
19070493
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.
Results Reference
background
PubMed Identifier
33894465
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.
Results Reference
derived
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Effects of the Insole on Balance Capacity in Chronic Stroke
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