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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505383
• Other study ID #: 2022/412
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2022
• Source: Saglik Bilimleri Universitesi
• Contact: Fatih Soke, Asst. Prof.
• Phone: +90 506 932 81 02
• Email: fatih.soke[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Exercise training
People with multiple sclerosis will be received a supervised physiotherapy and rehabilitation program.

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara
Turkey	Ankara University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi	Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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). pii: 1191. doi: 10.3390/healthcare9091191. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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