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Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Downhill walking
Walking on flat ground
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients diagnosed with stroke between the ages of 18 and 65 Dec Exclusion Criteria: 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, 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

Sites / Locations

  • Mamara Üniversitesi Tıp Fakültesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Walking on flat ground

-%7.5 Downhill walking

-%15 Downhill walking

Arm Description

Patients will walk for 20 minutes at a 0% slope.

They will walk downhill for 20 minutes at a -(negative)7.5% gradient.

They will walk downhill for 20 minutes at a -(negative)15% gradient.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Walking test
2 minute walking test
Walking test
2 minute walking test
Walking capacity
Timed Get Up and Walk Test
Walking capacity
Timed Get Up and Walk Test
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.
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.
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)
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)
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.
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.
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.
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.

Full Information

First Posted
March 28, 2023
Last Updated
April 26, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05833295
Brief Title
Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients
Official Title
Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 24, 2023 (Anticipated)
Primary Completion Date
May 24, 2023 (Anticipated)
Study Completion Date
April 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Patients will be randomized into 3 groups. Clinical and electrophysiological tests before and after walking sessions will be performed by an unannounced researcher.
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking on flat ground
Arm Type
Experimental
Arm Description
Patients will walk for 20 minutes at a 0% slope.
Arm Title
-%7.5 Downhill walking
Arm Type
Experimental
Arm Description
They will walk downhill for 20 minutes at a -(negative)7.5% gradient.
Arm Title
-%15 Downhill walking
Arm Type
Experimental
Arm Description
They will walk downhill for 20 minutes at a -(negative)15% gradient.
Intervention Type
Procedure
Intervention Name(s)
Downhill walking
Intervention Description
Change in the H/M ratio after a downhill walk.
Intervention Type
Procedure
Intervention Name(s)
Walking on flat ground
Intervention Description
Change in the H/M ratio after a Walking on flat ground
Primary Outcome Measure Information:
Title
the change in the H/M ratio after a 20-minute walk.
Description
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.
Time Frame
Day 0: Before the walk
Title
the change in the H/M ratio after a 20-minute walk.
Description
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.
Time Frame
Day 1: First day of 20-minute walk
Title
the change in the H/M ratio after a 20-minute walk.
Description
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.
Time Frame
Day 5: The fifth day of the 20-minute walk
Secondary Outcome Measure Information:
Title
Modified Asworth Scale
Description
Modified Asworth Scale is a spasticity assessment test. It contains 4 points in total. As the score increases, the degree of spasticity increases.
Time Frame
Day 0: Before the walk
Title
Modified Asworth Scale
Description
Modified Asworth Scale is a spasticity assessment test. It contains 4 points in total. As the score increases, the degree of spasticity increases.
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
Modified Tardeu Scale
Description
Modified Tardeu Scale is a spasticity assessment test. It contains 5 points in total. As the score increases, the degree of spasticity increases.
Time Frame
Day 0: Before the walk
Title
Modified Tardeu Scale
Description
Modified Tardeu Scale is a spasticity assessment test. It contains 5 points in total. As the score increases, the degree of spasticity increases.
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
Walking test
Description
2 minute walking test
Time Frame
Day 0: Before the walk
Title
Walking test
Description
2 minute walking test
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
Walking capacity
Description
Timed Get Up and Walk Test
Time Frame
Day 0: Before the walk
Title
Walking capacity
Description
Timed Get Up and Walk Test
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
The Fatigue Effect Scale
Description
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.
Time Frame
Day 0: Before the walk
Title
Fatigue
Description
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.
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
Stroke impact scale
Description
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)
Time Frame
Day 0: Before the walk
Title
Stroke impact scale
Description
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)
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
Berg Equilibrium Scale
Description
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.
Time Frame
Day 0: Before the walk
Title
Berg Equilibrium Scale
Description
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.
Time Frame
Day 5: The fifth day of the 20-minute walk
Title
Fugl-Meyer Assessment Scale
Description
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.
Time Frame
Day 0: Before the walk
Title
Fugl-Meyer Assessment Scale
Description
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.
Time Frame
Day 5: The fifth day of the 20-minute walk

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients diagnosed with stroke between the ages of 18 and 65 Dec Exclusion Criteria: 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burak Yıldız, Dr.
Phone
05546797417
Email
adaletli_26@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Özge Keniş Coşkun, MD
Phone
05058294947
Email
Ozgekenis@gmail.com
Facility Information:
Facility Name
Mamara Üniversitesi Tıp Fakültesi
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özge Keniş Coşkun, MD
Phone
02167775500
Email
tip.etikkurul@marmara.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients

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