The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, backward walking training, balance, gait, functional mobility
Eligibility Criteria
Inclusion Criteria:
- at least 18 years,
- neurologist-diagnosed Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5,
- no MS exacerbation within the last 3 months,
- use of stable medication in the last 3 months,
- not received immunomodulator treatment within the last 6 months,
Exclusion Criteria:
- other neurologic disorder,
- Pregnancy,
- Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program
Sites / Locations
- Ankara UniversityRecruiting
- Ankara UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Backward walking training group
Conventional gait training
Arm Description
This group will participate in a backward walking training program (8-week, 3 times weekly, and 30-min each time) and conventional gait training program (8-week, 3 times weekly, and 45-min each time).
This group will participate in a conventional gait training program (8-week, 3 times weekly, and 45-min each time).
Outcomes
Primary Outcome Measures
Berg Balance Scale [Time Frame: 10 minutes]
Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.
Four Square Step Test
The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square.
Activities-specific Balance Confidence Scale
Participants are asked to rate their balance confidence level 0% and 100% in the 16-item related to various everyday activities. The mean score on the 16-item questionnaire ranges from 0 to 100% and higher scores indicate a better balance confidence.
10 Meter Walk Test
The 10-Meter Walk Test is a commonly used measure for assessing walking speed. For the 10 Meter Walk Test, two end lines and two buffer lines were taped on the ground. Each end line was 14 m from the other and the each buffer line was 2 m from the end line. The time to walk the middle 10 m was recorded using a stopwatch.
Timed 25-feet Walk Test
People with multiple sclerosis are instructed to walk 25 feet as fast, but safely, as possible. This test is timed from the moment the patient crossed the start line and stopped when people with multiple sclerosis is crossed the finish line.
Six Minute Walk Test
It is used to measure gait performance. Participants are instructed to walk as far as they could over 6 min. The total distance that a people can walk was measured in meters.
3-meter Backward Walk Test
The 3-m course was determined and marked with black tape on the tile or wood surface. The test was started by asking participants to stand straight facing backward and to position their heels at the baseline level of the black tape. The examiner instructed the participants to walk backward rapidly, but as safely as possible. This test was performed with 3 trials, and the average time was expressed in seconds.
Dynamic Gait Index
This test is designed to test eight facets of gait, including gait on even surface, gait with changing speed, gait with head turns in vertical and horizontal planes, stepping over or around obstacles, gait with pivot turns, and stair ascent and descent. It is scored a four-point ordinal scale, ranging from 0 to 3. The best possible score on the dynamic gait index is a 24.
Multiple Sclerosis Walking Scale-12
The Multiple Sclerosis Walking Scale-12 is a 12-item patient-rated measure of the impact of multiple sclerosis on walking. Each item is rated on a scale ranging between 1 (Not at all) and 5 (Extremely). The total MSWS-12 score is computed by subtracting the minimum possible score of 12 points from the participant's score (i.e., sum of the 12 item scores), dividing by the maximal score of 60 points, and then multiplying the result by 100. This lead to a possible range of MSWS-12 scores between 0 and 80.
Timed Up and Go Test
TUG is used to assess functional mobility. Participants are given verbal instruction to stand up from an armchair, walk forward 3 m, turn round, walk back towards the armchair and sit down. The time taken to complete is recorded.
Secondary Outcome Measures
Full Information
NCT ID
NCT05505383
First Posted
August 16, 2022
Last Updated
August 19, 2022
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Ankara University
1. Study Identification
Unique Protocol Identification Number
NCT05505383
Brief Title
The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis
Official Title
The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Ankara 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
Backward walking training can be a useful treatment approach, providing novel balance and gait challenges. It can lead to improve balance, gait and functional mobility in neurologic populations. However, the effect of backward walking training has net been investigated in people with multiple sclerosis.
Detailed Description
Multiple sclerosis is a chronic autoimmune disease of the central nervous system. Patients with multiple sclerosis have problems in balance, gait, and functional mobility. This problems can lead to falls, injuries, hospitalization, limited daily living activities, and decreased quality of life. Backward walking is a popular training approach to improve balance, gait, and functional mobility in other neurological disease such as stroke, and Parkinson's disease. Moreover, backward walking performance decreases in multiple sclerosis. However, no study has been performed to determine the effectiveness of backward walking training in multiple sclerosis. Therefore, this study aimed to investigate the effect of backward walking training on balance, gait, and functional mobility in patients with multiple sclerosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, backward walking training, balance, gait, functional mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Backward walking training group
Arm Type
Experimental
Arm Description
This group will participate in a backward walking training program (8-week, 3 times weekly, and 30-min each time) and conventional gait training program (8-week, 3 times weekly, and 45-min each time).
Arm Title
Conventional gait training
Arm Type
Active Comparator
Arm Description
This group will participate in a conventional gait training program (8-week, 3 times weekly, and 45-min each time).
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
People with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program.
Primary Outcome Measure Information:
Title
Berg Balance Scale [Time Frame: 10 minutes]
Description
Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.
Time Frame
10 minutes
Title
Four Square Step Test
Description
The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square.
Time Frame
15 seconds
Title
Activities-specific Balance Confidence Scale
Description
Participants are asked to rate their balance confidence level 0% and 100% in the 16-item related to various everyday activities. The mean score on the 16-item questionnaire ranges from 0 to 100% and higher scores indicate a better balance confidence.
Time Frame
2 minutes
Title
10 Meter Walk Test
Description
The 10-Meter Walk Test is a commonly used measure for assessing walking speed. For the 10 Meter Walk Test, two end lines and two buffer lines were taped on the ground. Each end line was 14 m from the other and the each buffer line was 2 m from the end line. The time to walk the middle 10 m was recorded using a stopwatch.
Time Frame
20 seconds
Title
Timed 25-feet Walk Test
Description
People with multiple sclerosis are instructed to walk 25 feet as fast, but safely, as possible. This test is timed from the moment the patient crossed the start line and stopped when people with multiple sclerosis is crossed the finish line.
Time Frame
1 minutes
Title
Six Minute Walk Test
Description
It is used to measure gait performance. Participants are instructed to walk as far as they could over 6 min. The total distance that a people can walk was measured in meters.
Time Frame
6 minutes
Title
3-meter Backward Walk Test
Description
The 3-m course was determined and marked with black tape on the tile or wood surface. The test was started by asking participants to stand straight facing backward and to position their heels at the baseline level of the black tape. The examiner instructed the participants to walk backward rapidly, but as safely as possible. This test was performed with 3 trials, and the average time was expressed in seconds.
Time Frame
10 seconds
Title
Dynamic Gait Index
Description
This test is designed to test eight facets of gait, including gait on even surface, gait with changing speed, gait with head turns in vertical and horizontal planes, stepping over or around obstacles, gait with pivot turns, and stair ascent and descent. It is scored a four-point ordinal scale, ranging from 0 to 3. The best possible score on the dynamic gait index is a 24.
Time Frame
5 minutes
Title
Multiple Sclerosis Walking Scale-12
Description
The Multiple Sclerosis Walking Scale-12 is a 12-item patient-rated measure of the impact of multiple sclerosis on walking. Each item is rated on a scale ranging between 1 (Not at all) and 5 (Extremely). The total MSWS-12 score is computed by subtracting the minimum possible score of 12 points from the participant's score (i.e., sum of the 12 item scores), dividing by the maximal score of 60 points, and then multiplying the result by 100. This lead to a possible range of MSWS-12 scores between 0 and 80.
Time Frame
2 minutes
Title
Timed Up and Go Test
Description
TUG is used to assess functional mobility. Participants are given verbal instruction to stand up from an armchair, walk forward 3 m, turn round, walk back towards the armchair and sit down. The time taken to complete is recorded.
Time Frame
15 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 18 years,
neurologist-diagnosed Multiple Sclerosis,
Expanded Disability Status Scale (EDSS) score between 0 and 5.5,
no MS exacerbation within the last 3 months,
use of stable medication in the last 3 months,
not received immunomodulator treatment within the last 6 months,
Exclusion Criteria:
other neurologic disorder,
Pregnancy,
Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Soke, Asst. Prof.
Phone
+90 506 932 81 02
Email
fatih.soke@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan Yucesan, Prof. Dr.
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canan Yucesan, Prof. Dr.
Phone
+903125082220
Email
canan.yucesan@ankara.edu.tr
First Name & Middle Initial & Last Name & Degree
Fatih Soke, Asst. Prof.
Facility Name
Ankara University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canan Yucesan, Prof. Dr.
Email
canan.yucesan@ankara.edu.tr
First Name & Middle Initial & Last Name & Degree
Fatih Soke, Asst. Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30616175
Citation
Wang J, Xu J, An R. Effectiveness of backward walking training on balance performance: A systematic review and meta-analysis. Gait Posture. 2019 Feb;68:466-475. doi: 10.1016/j.gaitpost.2019.01.002. Epub 2019 Jan 3.
Results Reference
background
PubMed Identifier
29232308
Citation
Rose DK, DeMark L, Fox EJ, Clark DJ, Wludyka P. A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. J Neurol Phys Ther. 2018 Jan;42(1):12-21. doi: 10.1097/NPT.0000000000000210.
Results Reference
background
PubMed Identifier
34574964
Citation
Choi JY, Son SM, Park SH. A Backward Walking Training Program to Improve Balance and Mobility in Children with Cerebral Palsy. Healthcare (Basel). 2021 Sep 9;9(9):1191. doi: 10.3390/healthcare9091191.
Results Reference
background
PubMed Identifier
30998551
Citation
Moon Y, Bae Y. Backward walking observational training improves gait ability in patients with chronic stroke: randomised controlled pilot study. Int J Rehabil Res. 2019 Sep;42(3):217-222. doi: 10.1097/MRR.0000000000000352.
Results Reference
background
PubMed Identifier
29804040
Citation
Wang J, Yuan W, An R. Effectiveness of backward walking training on spatial-temporal gait characteristics: A systematic review and meta-analysis. Hum Mov Sci. 2018 Aug;60:57-71. doi: 10.1016/j.humov.2018.05.007. Epub 2018 May 24.
Results Reference
background
PubMed Identifier
31311448
Citation
DeMark L, Fox EJ, Spigel PM, Osborne J, Rose DK. Clinical application of backward walking training to improve walking function, balance, and fall-risk in acute stroke: a case series. Top Stroke Rehabil. 2019 Oct;26(7):497-502. doi: 10.1080/10749357.2019.1641011. Epub 2019 Jul 16.
Results Reference
background
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The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis
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