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Effects of Backward Gait Training in Chronic Stroke Patients

Primary Purpose

Chronic Stroke Patients

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Backward Walking Training
Forward Walking Training
Sponsored by
Bandırma Onyedi Eylül University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke Patients focused on measuring Chronic Stroke Patients, Balance, Plantar Pressure Distribution, Respiratory Parameters, Backward Gait Training

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burçin AkçayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Backward Walking Group

Forward Walking Group

Arm Description

Conventional therapy + Backward Walking Training

Conventional therapy + Forward Walking Training

Outcomes

Primary Outcome Measures

Plantar pressure assessment
Plantar pressure distribution will be evaluated.
Balance assessment
Static and dynamic balance will be evaluated with The Korebalance Premiere device.
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.
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.
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.
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.
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.
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device

Secondary Outcome Measures

Full Information

First Posted
May 18, 2021
Last Updated
March 13, 2022
Sponsor
Bandırma Onyedi Eylül University
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1. Study Identification

Unique Protocol Identification Number
NCT04903392
Brief Title
Effects of Backward Gait Training in Chronic Stroke Patients
Official Title
Investigation of the Effects of Gait Training on Balance, Plantar Pressure Distribution and Respiratory Parameters in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bandırma Onyedi Eylül University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke Patients
Keywords
Chronic Stroke Patients, Balance, Plantar Pressure Distribution, Respiratory Parameters, Backward Gait Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Backward Walking Group
Arm Type
Experimental
Arm Description
Conventional therapy + Backward Walking Training
Arm Title
Forward Walking Group
Arm Type
Other
Arm Description
Conventional therapy + Forward Walking Training
Intervention Type
Other
Intervention Name(s)
Backward Walking Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Forward Walking Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Plantar pressure assessment
Description
Plantar pressure distribution will be evaluated.
Time Frame
6 weeks
Title
Balance assessment
Description
Static and dynamic balance will be evaluated with The Korebalance Premiere device.
Time Frame
6 weeks
Title
Pulmonary function (Forced vital capacity (FVC))
Description
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.
Time Frame
6 weeks
Title
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Description
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.
Time Frame
6 weeks
Title
Pulmonary function (FEV1 / FVC)
Description
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.
Time Frame
6 weeks
Title
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Description
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.
Time Frame
6 weeks
Title
Pulmonary function (Peak flow rate (PEF))
Description
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.
Time Frame
6 weeks
Title
Respiratory Muscle Strength
Description
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burçin Akçay
Phone
+905056533273
Email
akcayburcin@gmail.com
Facility Information:
Facility Name
Burçin Akçay
City
Balıkesir
ZIP/Postal Code
10200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burçin Akçay
Phone
+905056533273
Email
akcayburcin@gmail.com
First Name & Middle Initial & Last Name & Degree
Melike Sümeyye Özen
First Name & Middle Initial & Last Name & Degree
Esra Keskin
First Name & Middle Initial & Last Name & Degree
Şule Keçelioğlu
First Name & Middle Initial & Last Name & Degree
Gülhan Yılmaz Gökmen
First Name & Middle Initial & Last Name & Degree
Fatma Nur Yılmaz
First Name & Middle Initial & Last Name & Degree
Ali Doğan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28759977
Citation
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.
Results Reference
background
PubMed Identifier
32508341
Citation
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.
Results Reference
background
PubMed Identifier
14667946
Citation
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.
Results Reference
background
PubMed Identifier
17198591
Citation
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.
Results Reference
background
PubMed Identifier
15859527
Citation
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.
Results Reference
background

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Effects of Backward Gait Training in Chronic Stroke Patients

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