Chronic Stroke PatientsNCT03702517
Lateral Stair Walking Training After Chronic Stroke
A study testing lateral stair walking exercise and traditional physiotherapy in people with Chronic Stroke Patients, run by Kaohsiung Veterans General Hospital..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- lateral stair walking exercise and traditional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2016to 30 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- cognitively impaired,
- visually impairedor
- unable to receive training due to other diseases (lung, heart, gastrointestinal tract, bone and muscle, nervous system etc.)
About this study
Official title: Efficacy of Lateral Stair Walking Training in Patients With Chronic Stroke: a Pilot Randomized Controlled Study
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.
Read the 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.
- Conditions
- Chronic Stroke Patients
- Being tested
- lateral stair walking exercise, traditional physiotherapy
- Keywords
- lateral stair walking, range of motion, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral stair walking exerciseDevice
Also called stair walking training
15 minutes of lateral stair walking exercise
traditional physiotherapyDevice
Also called physical therapy
strengthening exercise, balance training and gait training
| Study group | Role | What they receive |
|---|---|---|
| lateral stair walking exercise | Experimental | The experimental group received 15 minutes of lateral stair walking exercise Receives: Device: lateral stair walking exercise; Device: traditional physiotherapy |
| traditional physiotherapy | Active comparator | strengthening exercise, balance training and gait training Receives: Device: lateral stair walking exercise; Device: traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (8)
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.
Measured: 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.
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.
Measured: 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.
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 .
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start3 Jan 2016
- Primary completion5 May 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Yun Huang, Kaohsiung Veterans General Hospital.
- Investigators
- I-Hsiu Liou, MD., Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702517
- Sponsor's protocol ID
- VGHKS15-CT8-23
- Status last verified
- Jan 2024
- First submitted
- 4 Oct 2018
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lateral Stair Walking Training in Patients With Chronic Stroke: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03702517
- Acronym / sponsor ID
- VGHKS15-CT8-23
- Conditions
- Chronic Stroke Patients
- Keywords
- lateral stair walking, range of motion, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral stair walking exercise | Experimental | Device: lateral stair walking exercise, Device: traditional physiotherapyThe experimental group received 15 minutes of lateral stair walking exercise |
| traditional physiotherapy | Active comparator | Device: lateral stair walking exercise, Device: traditional physiotherapystrengthening exercise, balance training and gait training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- cognitively impaired,
- visually impairedor
- unable to receive training due to other diseases (lung, heart, gastrointestinal tract, bone and muscle, nervous system etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral stair walking exerciseAlso: stair walking training15 minutes of lateral stair walking exercise | Device | lateral stair walking exercise, traditional physiotherapy |
| traditional physiotherapyAlso: physical therapystrengthening exercise, balance training and gait training | Device | lateral stair walking exercise, traditional physiotherapy |
Primary outcome
muscle strength
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.
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.
8 secondary outcomes
The postural assessment scale for stroke patients (PASS)
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.
Fugal-Meyer assessment for Lower extremity,
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.
Barthel index for Activities of Daily Living (ADL)
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.
Timed up and go test (TUG)
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.
Reha Gait® for gait parameters.
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.
Passive range of motion (PROM)
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.
active range of motion (AROM)
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.
The Brunnstrom motor recovery stage of Lower extremity (LE):
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Kaohsiung Veterans General HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Hsiu Liou, MD. study chair
Kaohsiung Veterans General Hospital.
Questions about this trial
What is this clinical trial studying?
A study testing lateral stair walking exercise and traditional physiotherapy in people with Chronic Stroke Patients, run by Kaohsiung Veterans General Hospital..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.