StrokeNCT05833295
Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients
A study testing Downhill walking and Walking on flat ground in people with Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
investigation of the effects of walking for 20 minutes on the acute H/M ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Downhill walking and Walking on flat ground
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2023to 24 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with stroke between the ages of 18 and 65 Dec
Who cannot join
- Other neurological disorders,
- Expressive or receptive aphasias,
- Severe heart disease,
- A history of poorly controlled diabetes,
- Active cancer,
- Those who have been injected with botilinum toxin in the last 3 months,
Show all 9Show fewer
- Orthopedic conditions affecting the legs, a history of hip or knee replacement,
- Serious simultaneous medical problems, such as peripheral nerve damage
- Inability to comprehend verbal instructions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mamara Üniversitesi Tıp Fakültesi
Istanbul, 34000
Özge Keniş Coşkun, MD, 02167775500, tip.etikkurul@marmara.edu.tr
About this study
investigation of the effects of walking for 20 minutes on the acute H/M ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory.
At the same time, the aim of the study is to obtain the clinical effectiveness of this walking pattern and control of the H/M ratio by checking the H/M ratio again after 5 sessions and 20 minutes of walking for the patients participating in the study.
Read the detailed description
Participants will wear a seat belt connected to an overhead support and will walk on a treadmill with a dual-band instrument at a sampling frequency of 2000 Hz. The seat belt will only serve as a safety mechanism in case of a fall and will not support any body weight while walking. Each participant will walk for 20 minutes under one of 3 slope conditions; treadmill walking on 0° flat ground, , downhill walking with treadmill on -7.5° slope and downhill walking with treadmill on -15° slope.
First, by asking the participants to walk at their comfortable speed for straight walking on the treadmill with tools, the walking speed will be determined and carried out at the specified speeds. All self-selected walking speeds will be determined in two 30-second trials. During the 20-minute walk for each condition, if the participant needs to slow down, the speed of the treadmill will be reduced to adapt to this, and the average walking speed during the 20-minute walking session will be reported. Pulse and blood pressure will be monitored before, during and after the walk.
All participants will be evaluated with modified asworth scale, modified tardeu scale, 2 minute walking test, modified rankin scale, timed get up and walk test, fatigue impact scale, stroke impact scale, berg balance scale, fugl meyer assessment scale before treatment.
Patients will be randomized into 3 groups. Then, the H / M ratio will be looked at in all 3 groups. After the first walking session, the H / M ratio will be repeated. after completing the 5-session walking program, clinical and electrophysiological tests will be repeated.
- Conditions
- Stroke
- Being tested
- Downhill walking, Walking on flat ground
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Downhill walkingProcedure or surgery
Change in the H/M ratio after a downhill walk.
Walking on flat groundProcedure or surgery
Change in the H/M ratio after a Walking on flat ground
| Study group | Role | What they receive |
|---|---|---|
| Walking on flat ground | Experimental | Patients will walk for 20 minutes at a 0% slope. Receives: Procedure: Walking on flat ground |
| -%7.5 Downhill walking | Experimental | They will walk downhill for 20 minutes at a -(negative)7.5% gradient. Receives: Procedure: Downhill walking |
| -%15 Downhill walking | Experimental | They will walk downhill for 20 minutes at a -(negative)15% gradient. Receives: Procedure: Downhill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in the H/M ratio after a 20-minute walk.
Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.
Measured: Day 0: Before the walk
the change in the H/M ratio after a 20-minute walk.
Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.
Measured: Day 1: First day of 20-minute walk
the change in the H/M ratio after a 20-minute walk.
Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.
Measured: Day 5: The fifth day of the 20-minute walk
Secondary outcomes (16)
Modified Asworth Scale
Modified Asworth Scale is a spasticity assessment test. It contains 4 points in total. As the score increases, the degree of spasticity increases.
Measured: Day 0: Before the walk
Modified Asworth Scale
Modified Asworth Scale is a spasticity assessment test. It contains 4 points in total. As the score increases, the degree of spasticity increases.
Measured: Day 5: The fifth day of the 20-minute walk
Modified Tardeu Scale
Modified Tardeu Scale is a spasticity assessment test. It contains 5 points in total. As the score increases, the degree of spasticity increases.
Measured: Day 0: Before the walk
Modified Tardeu Scale
Modified Tardeu Scale is a spasticity assessment test. It contains 5 points in total. As the score increases, the degree of spasticity increases.
Measured: Day 5: The fifth day of the 20-minute walk
Walking test
2 minute walking test
Measured: Day 0: Before the walk
Walking test
2 minute walking test
Measured: Day 5: The fifth day of the 20-minute walk
Walking capacity
Timed Get Up and Walk Test
Measured: Day 0: Before the walk
Walking capacity
Timed Get Up and Walk Test
Measured: Day 5: The fifth day of the 20-minute walk
The Fatigue Effect Scale
The fatigue effect scale consists of 9 questions. Each question gets points between 0 and 7. The total score is divided by the number of questions. If the result is greater than 6.1, it is defined as chronic fatigue.
Measured: Day 0: Before the walk
Fatigue
The fatigue effect scale consists of 9 questions. Each question gets points between 0 and 7. The total score is divided by the number of questions. If the result is greater than 6.1, it is defined as chronic fatigue.
Measured: Day 5: The fifth day of the 20-minute walk
Stroke impact scale
Stroke Impact Scale; patients' quality of life after stroke to assess their perception by themselves or their caregivers This scale consists of 8 subsections and 59 questions. each one question is a 5-point Likert scale of difficulty experienced in the past week.
It is scored by evaluation on the scale. each section The score ranges from 0 to 100. In addition, the stroke impact scale has 8 subsections.
0-100 point visual analog of the perception of recovery after stroke. scale (0: No improvement, 100: Full recovery)
Measured: Day 0: Before the walk
Stroke impact scale
Stroke Impact Scale; patients' quality of life after stroke to assess their perception by themselves or their caregivers This scale consists of 8 subsections and 59 questions. each one question is a 5-point Likert scale of difficulty experienced in the past week.
It is scored by evaluation on the scale. each section The score ranges from 0 to 100. In addition, the stroke impact scale has 8 subsections.
0-100 point visual analog of the perception of recovery after stroke. scale (0: No improvement, 100: Full recovery)
Measured: Day 5: The fifth day of the 20-minute walk
Berg Equilibrium Scale
It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating balance disorder, 21 40 points indicating an acceptable balance, 41-56 points indicating a good balance. It takes between 10 and 20 minutes to complete the scale.
It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating balance disorder, 21 40 points indicating an acceptable balance, 41-56 points indicating a good balance. It takes between 10 and 20 minutes to complete the scale.
Measured: Day 0: Before the walk
Berg Equilibrium Scale
It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating balance disorder, 21 40 points indicating an acceptable balance, 41-56 points indicating a good balance. It takes between 10 and 20 minutes to complete the scale.
Measured: Day 5: The fifth day of the 20-minute walk
Fugl-Meyer Assessment Scale
The full version of FMRS assesses five domains: motor function, balance, sensory function, range of motion (ROM) and joint pain. In the full version of the scale, when all subscales (sensory function 24 points, balance 14 points, ROM 44 points, joint pain 44 points and motor-coordination 100 points) are added, the maximum total score is 226. The motor-coordination subscale is a maximum of 66 points for the upper extremity and a maximum of 34 points for the lower extremities. Higher scores indicate better motor recovery. Each item is scored with a 3-point ordinal scale (0: unable at all, 1: partially able, 2: fully able). When items related to coordination and speed are not included in the evaluation in the lower extremity motor-coordination subscale, it is specified as the lower extremity motor subscale and its maximum score is evaluated out of 28.
Measured: Day 0: Before the walk
Fugl-Meyer Assessment Scale
The full version of FMRS assesses five domains: motor function, balance, sensory function, range of motion (ROM) and joint pain. In the full version of the scale, when all subscales (sensory function 24 points, balance 14 points, ROM 44 points, joint pain 44 points and motor-coordination 100 points) are added, the maximum total score is 226. The motor-coordination subscale is a maximum of 66 points for the upper extremity and a maximum of 34 points for the lower extremities. Higher scores indicate better motor recovery. Each item is scored with a 3-point ordinal scale (0: unable at all, 1: partially able, 2: fully able). When items related to coordination and speed are not included in the evaluation in the lower extremity motor-coordination subscale, it is specified as the lower extremity motor subscale and its maximum score is evaluated out of 28.
Measured: Day 5: The fifth day of the 20-minute walk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start24 Apr 2023 (estimated)
- Primary completion24 May 2023 (estimated)
- Study completion24 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833295
- Sponsor's protocol ID
- MAR.FTR.ST
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients
- ClinicalTrials.gov ID
- NCT05833295
- Acronym / sponsor ID
- MAR.FTR.ST
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 24 Apr 2023 (estimated)
- Primary completion
- 24 May 2023 (estimated)
- Study completion
- 24 Apr 2024 (estimated)
- First posted
- 27 Apr 2023 (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.
investigation of the effects of walking for 20 minutes on the acute H/M ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory.
At the same time, the aim of the study is to obtain the clinical effectiveness of this walking pattern and control of the H/M ratio by checking the H/M ratio again after 5 sessions and 20 minutes of walking for the patients participating in the study.
Detailed description
Participants will wear a seat belt connected to an overhead support and will walk on a treadmill with a dual-band instrument at a sampling frequency of 2000 Hz. The seat belt will only serve as a safety mechanism in case of a fall and will not support any body weight while walking. Each participant will walk for 20 minutes under one of 3 slope conditions; treadmill walking on 0° flat ground, , downhill walking with treadmill on -7.5° slope and downhill walking with treadmill on -15° slope.
First, by asking the participants to walk at their comfortable speed for straight walking on the treadmill with tools, the walking speed will be determined and carried out at the specified speeds. All self-selected walking speeds will be determined in two 30-second trials. During the 20-minute walk for each condition, if the participant needs to slow down, the speed of the treadmill will be reduced to adapt to this, and the average walking speed during the 20-minute walking session will be reported. Pulse and blood pressure will be monitored before, during and after the walk.
All participants will be evaluated with modified asworth scale, modified tardeu scale, 2 minute walking test, modified rankin scale, timed get up and walk test, fatigue impact scale, stroke impact scale, berg balance scale, fugl meyer assessment scale before treatment.
Patients will be randomized into 3 groups. Then, the H / M ratio will be looked at in all 3 groups. After the first walking session, the H / M ratio will be repeated. after completing the 5-session walking program, clinical and electrophysiological tests will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking on flat ground | Experimental | Procedure: Walking on flat groundPatients will walk for 20 minutes at a 0% slope. |
| -%7.5 Downhill walking | Experimental | Procedure: Downhill walkingThey will walk downhill for 20 minutes at a -(negative)7.5% gradient. |
| -%15 Downhill walking | Experimental | Procedure: Downhill walkingThey will walk downhill for 20 minutes at a -(negative)15% gradient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with stroke between the ages of 18 and 65 Dec
Key exclusion criteria (9 listed)
- Other neurological disorders,
- Those who have been injected with botilinum toxin in the last 3 months,
- Inability to comprehend verbal instructions
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 |
|---|---|---|
| Downhill walkingChange in the H/M ratio after a downhill walk. | Procedure or surgery | -%15 Downhill walking, -%7.5 Downhill walking |
| Walking on flat groundChange in the H/M ratio after a Walking on flat ground | Procedure or surgery | Walking on flat ground |
Primary outcome
the change in the H/M ratio after a 20-minute walk.
Time frame: Day 0: Before the walk
Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.
the change in the H/M ratio after a 20-minute walk.
Time frame: Day 1: First day of 20-minute walk
Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.
the change in the H/M ratio after a 20-minute walk.
Time frame: Day 5: The fifth day of the 20-minute walk
Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.
16 secondary outcomes
Modified Asworth Scale
Time frame: Day 0: Before the walk
Modified Asworth Scale
Time frame: Day 5: The fifth day of the 20-minute walk
Modified Tardeu Scale
Time frame: Day 0: Before the walk
Modified Tardeu Scale
Time frame: Day 5: The fifth day of the 20-minute walk
Walking test
Time frame: Day 0: Before the walk
Walking test
Time frame: Day 5: The fifth day of the 20-minute walk
Walking capacity
Time frame: Day 0: Before the walk
Walking capacity
Time frame: Day 5: The fifth day of the 20-minute walk
The Fatigue Effect Scale
Time frame: Day 0: Before the walk
Fatigue
Time frame: Day 5: The fifth day of the 20-minute walk
Stroke impact scale
Time frame: Day 0: Before the walk
Stroke impact scale
Time frame: Day 5: The fifth day of the 20-minute walk
Berg Equilibrium Scale
Time frame: Day 0: Before the walk
Berg Equilibrium Scale
Time frame: Day 5: The fifth day of the 20-minute walk
Fugl-Meyer Assessment Scale
Time frame: Day 0: Before the walk
Fugl-Meyer Assessment Scale
Time frame: Day 5: The fifth day of the 20-minute walk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Downhill walking and Walking on flat ground in people with Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burak Yıldız, Dr. (05546797417, adaletli_26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in the H/M ratio after a 20-minute walk. (time frame: Day 0: Before the walk). The study lists 3 primary outcomes in all. 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 27 Apr 2023.