Multiple SclerosisNCT05505383
The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis
A study testing Exercise training in people with Multiple Sclerosis, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Aug 2022to 20 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- other neurologic disorder,
- Pregnancy,
- Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara University
Ankara
Canan Yucesan, Prof. Dr., +903125082220, canan.yucesan@ankara.edu.tr
Fatih Soke, Asst. Prof.
- Recruiting
Ankara University
Ankara
Canan Yucesan, Prof. Dr., canan.yucesan@ankara.edu.tr
Fatih Soke, Asst. Prof.
About this study
Official title: The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis Patients
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise training
- Keywords
- multiple sclerosis, backward walking training, balance, gait, functional mobility
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
People with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Backward walking training group | Experimental | 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). Receives: Other: Exercise training |
| Conventional gait training | Active comparator | This group will participate in a conventional gait training program (8-week, 3 times weekly, and 45-min each time). Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
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.
Measured: 15 seconds
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.
Measured: 2 minutes
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.
Measured: 20 seconds
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.
Measured: 1 minutes
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.
Measured: 6 minutes
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.
Measured: 10 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.
Measured: 5 minutes
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.
Measured: 2 minutes
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.
Measured: 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start18 Aug 2022
- Primary completion20 Nov 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Fatih Söke, Saglik Bilimleri Universitesi
- Investigators
- Canan Yucesan, Prof. Dr., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505383
- Sponsor's protocol ID
- 2022/412
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30616175Rose 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.
PubMed 29232308Choi 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.
PubMed 34574964Moon 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.
PubMed 30998551Wang 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.
PubMed 29804040DeMark 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.
PubMed 31311448
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05505383
- Acronym / sponsor ID
- 2022/412
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, backward walking training, balance, gait, functional mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 17 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backward walking training group | Experimental | Other: Exercise trainingThis 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). |
| Conventional gait training | Active comparator | Other: Exercise trainingThis group will participate in a conventional gait training program (8-week, 3 times weekly, and 45-min each time). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- other neurologic disorder,
- Pregnancy,
- Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program
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 |
|---|---|---|
| Exercise trainingPeople with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program. | Other | Backward walking training group, Conventional gait training |
Primary outcome
Berg Balance Scale [Time Frame: 10 minutes]
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
Time frame: 15 seconds
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
Time frame: 2 minutes
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
Time frame: 20 seconds
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
Time frame: 1 minutes
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
Time frame: 6 minutes
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
Time frame: 10 seconds
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
Time frame: 5 minutes
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
Time frame: 2 minutes
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
Time frame: 15 seconds
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 30616175Wang 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.
- Background: PubMed 29232308Rose 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.
- Background: PubMed 34574964Choi 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.
- Background: PubMed 30998551Moon 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.
- Background: PubMed 29804040Wang 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.
- Background: PubMed 31311448DeMark 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.
- 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.
Canan Yucesan, Prof. Dr. principal investigator
Ankara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Multiple Sclerosis, run by Saglik Bilimleri Universitesi at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Fatih Soke, Asst. Prof. (+90 506 932 81 02, fatih.soke@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale [Time Frame: 10 minutes] (time frame: 10 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505383, which also lists 6 linked publications.
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 24 Aug 2022.