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Lateral Stair Walking Training After Chronic Stroke

Primary Purpose

Chronic Stroke Patients

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lateral stair walking exercise
traditional physiotherapy
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke Patients focused on measuring lateral stair walking, range of motion, muscle strength

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects who were diagnosed with stroke within 6 months to 6 years by a neurologist or physiatrists,
  • computerized tomography scan or magnetic resonance imaging scan showed unilateral brain damage,
  • no obvious cognitive impairment,
  • no serious bone and joint problems
  • could follow the instructions and steps of the experiment
  • walked 15 meters independently.

Exclusion Criteria:

  • cognitively impaired,
  • visually impairedor
  • unable to receive training due to other diseases (lung, heart, gastrointestinal tract, bone and muscle, nervous system etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    lateral stair walking exercise

    traditional physiotherapy

    Arm Description

    The experimental group received 15 minutes of lateral stair walking exercise

    strengthening exercise, balance training and gait training

    Outcomes

    Primary Outcome Measures

    muscle strength
    Mycroft 3 hand-held dynamometer18: It has good reliability. Muscle strength can be measured in Newton's. It is applied in assessing the muscle strength of subjects.

    Secondary Outcome Measures

    The postural assessment scale for stroke patients (PASS)
    The PASS assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance. Its advantage lies in the lack of ceiling effect and floor effect, and the static and dynamic balance of stroke patients can be assessed. It is rated on a scale from 0 to 3, (total score of = 36) The Higher scores indicate better balance in stroke patients.
    Fugal-Meyer assessment for Lower extremity,
    It is an assessment scale developed from Brunnstrom stage-L/E specifically dedicated to stroke patients. It is rated on a scale from 0 to 2. It has good reliability and validity.
    Barthel index for Activities of Daily Living (ADL)
    It is a basic scale for functional independence with reliability and validity, covering 10 items such as eating, transposition, personal hygiene, using the bathroom, showering, walking on flat ground, stair climbing, putting on clothes, controlling excretion, etc. The total score ranges from 0 to 100, which is the progressive scope for activities of daily living .
    Timed up and go test (TUG)
    In the Timed Up and Go Test time is recorded when rising from a chair, walking three metres, turning, and walking back. It has good sensitivity and specificity (sensitivity=87%, specificity=87%), and can assess balance and motor ability. The measured time can predict the fall of stroke patients.
    Reha Gait® for gait parameters.
    It has high reliability. By wearing the three-axis gyro sensor on the shoes, gait data can be collected and analyzed with a microcomputer via Bluetooth.
    Passive range of motion (PROM)
    Passive range of motion (PROM) and active range of motion (AROM) of hip, knee and ankle joints: The change in degree is measured with a goniometer before and after training.
    active range of motion (AROM)
    Passive range of motion (PROM) and active range of motion (AROM) of hip, knee and ankle joints: The change in degree is measured with a goniometer before and after training.
    The Brunnstrom motor recovery stage of Lower extremity (LE):
    The motor recovery was assessed using Brunnstrom motor recovery stage tool (Brunnstrom, 1970) that classifies it into 6 stages; 1) flaccidity; 2) spasticity is developing; 3) spasticity is maximum; 4) spasticity begins to decrease and some movement combinations become available; 5) spasticity is diminishing and more difficult movement combinations can be accomplish; 6) normal. It has good reliability and validity, and can assess the motor recovery of stroke patients. It is rated on a scale from 1 to 6.

    Full Information

    First Posted
    October 4, 2018
    Last Updated
    October 10, 2018
    Sponsor
    Kaohsiung Veterans General Hospital.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03702517
    Brief Title
    Lateral Stair Walking Training After Chronic Stroke
    Official Title
    Efficacy of Lateral Stair Walking Training in Patients With Chronic Stroke: a Pilot Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2016 (Actual)
    Primary Completion Date
    May 5, 2016 (Actual)
    Study Completion Date
    December 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kaohsiung Veterans General 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
    The experimental group received 15 minutes of lateral stair walking exercise and 30 minutes of traditional physiotherapy (strengthening exercise, balance training and gait training) each time. The measures were done by one experience physical therapist (not involve in the intervention) before receiving the intervention and at weeks four, eight, and twelve. It took 45 minutes for each subject to complete all measures each time.
    Detailed Description
    For lateral stair walking training, the dynamic stair trainer features four steps. The height can be adjusted from 0 to 16.5 centimeters, the stair was 0.74 m in width, with each step being 16 cm deep and 10 cm long. The experimental group received different heights of lateral stair walking training according to the patients' ability. The patients went up the stairs with the affected leg up first and they went down stairs with the sound leg leading first. For safety, the subjects held a handrail during the lateral stair walking exercise. The control group received traditional physiotherapy (strengthening exercise, balance training and gait training) for 30 minutes. Both the experimental group and control group received the intervention once a week for 12 weeks. All the interventions were done by the same physical therapist.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Stroke Patients
    Keywords
    lateral stair walking, range of motion, muscle strength

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lateral stair walking exercise
    Arm Type
    Experimental
    Arm Description
    The experimental group received 15 minutes of lateral stair walking exercise
    Arm Title
    traditional physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    strengthening exercise, balance training and gait training
    Intervention Type
    Device
    Intervention Name(s)
    lateral stair walking exercise
    Other Intervention Name(s)
    stair walking training
    Intervention Description
    15 minutes of lateral stair walking exercise
    Intervention Type
    Device
    Intervention Name(s)
    traditional physiotherapy
    Other Intervention Name(s)
    physical therapy
    Intervention Description
    strengthening exercise, balance training and gait training
    Primary Outcome Measure Information:
    Title
    muscle strength
    Description
    Mycroft 3 hand-held dynamometer18: It has good reliability. Muscle strength can be measured in Newton's. It is applied in assessing the muscle strength of subjects.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Secondary Outcome Measure Information:
    Title
    The postural assessment scale for stroke patients (PASS)
    Description
    The PASS assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance. Its advantage lies in the lack of ceiling effect and floor effect, and the static and dynamic balance of stroke patients can be assessed. It is rated on a scale from 0 to 3, (total score of = 36) The Higher scores indicate better balance in stroke patients.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    Fugal-Meyer assessment for Lower extremity,
    Description
    It is an assessment scale developed from Brunnstrom stage-L/E specifically dedicated to stroke patients. It is rated on a scale from 0 to 2. It has good reliability and validity.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    Barthel index for Activities of Daily Living (ADL)
    Description
    It is a basic scale for functional independence with reliability and validity, covering 10 items such as eating, transposition, personal hygiene, using the bathroom, showering, walking on flat ground, stair climbing, putting on clothes, controlling excretion, etc. The total score ranges from 0 to 100, which is the progressive scope for activities of daily living .
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    Timed up and go test (TUG)
    Description
    In the Timed Up and Go Test time is recorded when rising from a chair, walking three metres, turning, and walking back. It has good sensitivity and specificity (sensitivity=87%, specificity=87%), and can assess balance and motor ability. The measured time can predict the fall of stroke patients.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    Reha Gait® for gait parameters.
    Description
    It has high reliability. By wearing the three-axis gyro sensor on the shoes, gait data can be collected and analyzed with a microcomputer via Bluetooth.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    Passive range of motion (PROM)
    Description
    Passive range of motion (PROM) and active range of motion (AROM) of hip, knee and ankle joints: The change in degree is measured with a goniometer before and after training.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    active range of motion (AROM)
    Description
    Passive range of motion (PROM) and active range of motion (AROM) of hip, knee and ankle joints: The change in degree is measured with a goniometer before and after training.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
    Title
    The Brunnstrom motor recovery stage of Lower extremity (LE):
    Description
    The motor recovery was assessed using Brunnstrom motor recovery stage tool (Brunnstrom, 1970) that classifies it into 6 stages; 1) flaccidity; 2) spasticity is developing; 3) spasticity is maximum; 4) spasticity begins to decrease and some movement combinations become available; 5) spasticity is diminishing and more difficult movement combinations can be accomplish; 6) normal. It has good reliability and validity, and can assess the motor recovery of stroke patients. It is rated on a scale from 1 to 6.
    Time Frame
    Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: subjects who were diagnosed with stroke within 6 months to 6 years by a neurologist or physiatrists, computerized tomography scan or magnetic resonance imaging scan showed unilateral brain damage, no obvious cognitive impairment, no serious bone and joint problems could follow the instructions and steps of the experiment walked 15 meters independently. Exclusion Criteria: cognitively impaired, visually impairedor unable to receive training due to other diseases (lung, heart, gastrointestinal tract, bone and muscle, nervous system etc.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    I-Hsiu Liou, MD.
    Organizational Affiliation
    Kaohsiung Veterans General Hospital.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.vghks.gov.tw/
    Description
    Kaohsiung Veterans General Hospital

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    Lateral Stair Walking Training After Chronic Stroke

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