Effects of Backward Gait Training in Chronic Stroke Patients

Investigation of the Effects of Gait Training on Balance, Plantar Pressure Distribution and Respiratory Parameters in Chronic Stroke Patients

Loss of motor control after stroke, muscle weakness, abnormal movement patterns, spasticity, range of motion limitations and sensory dysfunction, resulting in a decrease in the load transferred to the affected limb, changes in gait pattern and balance skills. Post-stroke muscle weakness has been shown to occur not only in the lower and upper extremity muscles but also in the respiratory muscles. It was found that the plantar pressure distribution in the affected side feet was decreased in individuals with stroke and this situation negatively affected the walking function. A systematic review of treadmill training revealed that treadmill training significantly increased walking speed and walking distance. Learning to walk backwards is also recommended to improve the movement components required for walking forward. As a result of the investigations, although there are studies about the effects of back-walking training on walking and balance function in chronic stroke patients, there is no study investigating the effects on plantar pressure distribution and respiratory parameters. Therefore, this study, which planned to investigate the effects of treadmill retching training on balance, plantar pressure distribution and respiratory parameters in chronic stroke patients, will contribute to the literature.

Study Overview

• Status: Recruiting
• Conditions: Chronic Stroke Patients
• Intervention / Treatment: Other: Backward Walking Training; Other: Forward Walking Training

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burçin Akçay; Phone Number: +905056533273; Email: akcayburcin@gmail.com

Study Locations

• Turkey
  • Balıkesir, Turkey, 10200
    • Recruiting
    • Burçin Akçay
    • Contact: Burçin Akçay; Phone Number: +905056533273; Email: akcayburcin@gmail.com
    • Sub-Investigator: Gülhan Yılmaz Gökmen
    • Sub-Investigator: Fatma Nur Yılmaz
    • Sub-Investigator: Melike Sümeyye Özen
    • Sub-Investigator: Esra Keskin
    • Sub-Investigator: Şule Keçelioğlu
    • Sub-Investigator: Ali Doğan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Volunteering to participate in the study
• More than 6 months have passed since the onset of stroke
• First time stroke diagnosis
• Being between the ages of 40-65
• Spasticity severity in lower extremity less than 3 according to Modified Ashworth Scale,
• Being medically stable
• Ability to walk 10 meters and above without assistance

Exclusion Criteria:

• Presence of other neurological or orthopedic diseases that affect standing and walking involving the lower limbs
• Uncontrollable Hypertension
• Having been diagnosed with any pulmonary disease
• Severe cardiac conditions
• Uncontrollable DM
• Lack of cooperation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Backward Walking Group; Conventional therapy + Backward Walking Training	Other: Backward Walking Training; The training speed will start at the basic walking speed and will increase by 5% of the starting speed each week. The training, which will take 30 minutes, will be as follows: 5 minutes forward walking (warm-up phase), 20 minutes backward walking (intervention phase) and 5 minutes forward (cooling phase). -three times a week for six weeks
Other: Forward Walking Group; Conventional therapy + Forward Walking Training	Other: Forward Walking Training; The training speed will start at the basic walking speed and will increase by 5% of the starting speed each week. It will be in the form of walking forward for 30 minutes. -three times a week for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function (Forced vital capacity (FVC))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.	6 weeks
Pulmonary function (Forced expiratory volume in the first second (FEV1))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.	6 weeks
Pulmonary function (FEV1 / FVC)	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.	6 weeks
Plantar pressure assessment	Plantar pressure distribution will be evaluated.	6 weeks
Balance assessment	Static and dynamic balance will be evaluated with The Korebalance Premiere device.	6 weeks
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.	6 weeks
Pulmonary function (Peak flow rate (PEF))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.	6 weeks
Respiratory Muscle Strength	Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device	6 weeks

Collaborators and Investigators

• Sponsor: Bandırma Onyedi Eylül University

Publications and helpful links

General Publications

• Yang YR, Yen JG, Wang RY, Yen LL, Lieu FK. Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial. Clin Rehabil. 2005 May;19(3):264-73. doi: 10.1191/0269215505cr860oa.
• Kim KH, Lee KB, Bae YH, Fong SSM, Lee SM. Effects of progressive backward body weight suppoted treadmill training on gait ability in chronic stroke patients: A randomized controlled trial. Technol Health Care. 2017 Oct 23;25(5):867-876. doi: 10.3233/THC-160720.
• Munari D, Serina A, Disaro J, Modenese A, Filippetti M, Gandolfi M, Smania N, Picelli A. Combined effects of backward treadmill training and botulinum toxin type A therapy on gait and balance in patients with chronic stroke: A pilot, single-blind, randomized controlled trial. NeuroRehabilitation. 2020;46(4):519-528. doi: 10.3233/NRE-203067.
• Nadeau S, Amblard B, Mesure S, Bourbonnais D. Head and trunk stabilization strategies during forward and backward walking in healthy adults. Gait Posture. 2003 Dec;18(3):134-42. doi: 10.1016/s0966-6362(02)00070-x.
• Weng CS, Wang J, Pan XY, Yu ZZ, Wang G, Gao LP, Huo CN. [Effectiveness of backward walking treadmill training in lower extremity function after stroke]. Zhonghua Yi Xue Za Zhi. 2006 Oct 10;86(37):2635-8. Chinese.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Balance; Respiratory Parameters; Plantar Pressure Distribution; Chronic Stroke Patients; Backward Gait Training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: BAkcay

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