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

NCT05505383 | Unknown

• 1 other identifier: 2022/412
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; backward walking training; balance; gait; functional mobility

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  15 seconds

Study Arms (2)

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).

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).

Other: Exercise training

Interventions

Exercise training OTHER

People with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program.

Backward walking training group; Conventional gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• other neurologic disorder,
• Pregnancy,
• Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Ankara University: collaborator

Study Sites (2)

Ankara University

Ankara, Turkey (Türkiye)

RECRUITING

Ankara University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 30616175 BACKGROUND

• 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.

  PMID: 29232308 BACKGROUND

• 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.

  PMID: 34574964 BACKGROUND

• 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.

  PMID: 30998551 BACKGROUND

• 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.

  PMID: 29804040 BACKGROUND

• 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.

  PMID: 31311448 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Canan Yucesan, Prof. Dr.

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatih Soke, Asst. Prof.

CONTACT

+90 506 932 81 02; fatih.soke@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 18, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)