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Effects of the Insole on Balance Capacity in Chronic Stroke

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ClinicalTrials.gov Identifier: NCT03194282
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke, Cardiovascular Other: insole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Effects of the Insole on Balance Capacity in Chronic Stroke
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 25, 2018

Arm Intervention/treatment
Experimental: chronic stroke patient with insole
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
The subjects are randomly assigned to assess balance capacity either with or without insole.

Sham Comparator: chronic stroke patient without insole
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
The subjects are randomly assigned to assess balance capacity either with or without insole.




Primary Outcome Measures :
  1. Change in Berg balance scale from pre to post-intervention. [ Time Frame: 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.

  2. Change in Functional Reach Test(FRT) from pre to post-intervention. [ Time Frame: up to 10 minutes. ]
    The Functional Reach Test (FRT) is a quick screen for determining risk for falls.

  3. Change in Timed Up and Go (TUG) Test from pre to post-intervention. [ Time Frame: up to 10 minutes. ]
    Timed Up and Go (TUG) Test was developed to assess mobility.


Secondary Outcome Measures :
  1. Change in Center of pressure (CoP) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The center of pressure (CoP) measures derived from the foot pressure mat and force plate of Biodex Balance system.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194282


Locations
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Taiwan
Wang Fang hospital
Taipei, Taipei City, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Study Chair: YENTING LIU, Master Wang Fang Hospital, Taipei Medical University

Publications:
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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03194282     History of Changes
Other Study ID Numbers: N201705003
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University WanFang Hospital:
stroke
balance
insole
Additional relevant MeSH terms:
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Stroke
Myocardial Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases