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The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05505383
Recruitment Status : Recruiting
First Posted : August 17, 2022
Last Update Posted : August 24, 2022
Sponsor:
Collaborator:
Ankara University
Information provided by (Responsible Party):
Fatih Söke, Saglik Bilimleri Universitesi

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Exercise training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis Patients
Actual Study Start Date : August 18, 2022
Estimated Primary Completion Date : November 20, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Backward walking training group
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).
Other: Exercise training
People with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program.

Active Comparator: Conventional gait training
This group will participate in a conventional gait training program (8-week, 3 times weekly, and 45-min each time).
Other: Exercise training
People with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05505383


Contacts
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Contact: Fatih Soke, Asst. Prof. +90 506 932 81 02 fatih.soke@sbu.edu.tr

Locations
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Turkey
Ankara University Recruiting
Ankara, Turkey
Contact: Canan Yucesan, Prof. Dr.    +903125082220    canan.yucesan@ankara.edu.tr   
Principal Investigator: Fatih Soke, Asst. Prof.         
Ankara University Recruiting
Ankara, Turkey
Contact: Canan Yucesan, Prof. Dr.       canan.yucesan@ankara.edu.tr   
Principal Investigator: Fatih Soke, Asst. Prof.         
Sponsors and Collaborators
Saglik Bilimleri Universitesi
Ankara University
Investigators
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Principal Investigator: Canan Yucesan, Prof. Dr. Ankara University
Publications:
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Responsible Party: Fatih Söke, Assistant Professor, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT05505383    
Other Study ID Numbers: 2022/412
First Posted: August 17, 2022    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatih Söke, Saglik Bilimleri Universitesi:
multiple sclerosis
backward walking training
balance
gait
functional mobility
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases