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

August 19, 2022 updated by: Fatih Söke, Saglik Bilimleri Universitesi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara University
        • Principal Investigator:
          • Fatih Soke, Asst. Prof.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
15 seconds
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.
10 minutes
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.
2 minutes
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.
20 seconds
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.
1 minutes
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.
6 minutes
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.
10 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.
5 minutes
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.
2 minutes
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.
15 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Canan Yucesan, Prof. Dr., Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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