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

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
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
NCT ID
NCT03702517
First Posted
October 4, 2018
Last Updated
October 10, 2018
Sponsor
Kaohsiung Veterans General Hospital.
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
Learn more about this trial
Lateral Stair Walking Training After Chronic Stroke
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