Chronic Stroke PatientsNCT04903392
Effects of Backward Gait Training in Chronic Stroke Patients
A study testing Backward Walking Training and Forward Walking Training in people with Chronic Stroke Patients, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- Backward Walking Training and Forward Walking Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Burçin Akçay
Balıkesir, 10200
Burçin Akçay, +905056533273, akcayburcin@gmail.com
Melike Sümeyye Özen
About this study
Official title: 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.
- Conditions
- Chronic Stroke Patients
- Being tested
- Backward Walking Training, Forward Walking Training
- Keywords
- Chronic Stroke Patients, Balance, Plantar Pressure Distribution, Respiratory Parameters, Backward Gait Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Walking TrainingOther
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
Forward Walking TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Backward Walking Group | Experimental | Conventional therapy + Backward Walking Training Receives: Other: Backward Walking Training |
| Forward Walking Group | Other | Conventional therapy + Forward Walking Training Receives: Other: Forward Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar pressure assessment
Plantar pressure distribution will be evaluated.
Measured: 6 weeks
Balance assessment
Static and dynamic balance will be evaluated with The Korebalance Premiere device.
Measured: 6 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Akçay, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903392
- Sponsor's protocol ID
- BAkcay
- Status last verified
- Mar 2022
- First submitted
- 18 May 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28759977Munari 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.
PubMed 32508341Nadeau 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.
PubMed 14667946Weng 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.
PubMed 17198591Yang 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.
PubMed 15859527
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Gait Training on Balance, Plantar Pressure Distribution and Respiratory Parameters in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04903392
- Acronym / sponsor ID
- BAkcay
- Conditions
- Chronic Stroke Patients
- Keywords
- Chronic Stroke Patients, Balance, Plantar Pressure Distribution, Respiratory Parameters, Backward Gait Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backward Walking Group | Experimental | Other: Backward Walking TrainingConventional therapy + Backward Walking Training |
| Forward Walking Group | Other | Other: Forward Walking TrainingConventional therapy + Forward Walking Training |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Backward Walking TrainingThe 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 | Backward Walking Group |
| Forward Walking TrainingThe 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 | Other | Forward Walking Group |
Primary outcome
Plantar pressure assessment
Time frame: 6 weeks
Plantar pressure distribution will be evaluated.
Balance assessment
Time frame: 6 weeks
Static and dynamic balance will be evaluated with The Korebalance Premiere device.
Pulmonary function (Forced vital capacity (FVC))
Time frame: 6 weeks
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))
Time frame: 6 weeks
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)
Time frame: 6 weeks
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%))
Time frame: 6 weeks
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))
Time frame: 6 weeks
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
Time frame: 6 weeks
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Background: PubMed 28759977Kim 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.
- Background: PubMed 32508341Munari 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.
- Background: PubMed 14667946Nadeau 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.
- Background: PubMed 17198591Weng 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.
- Background: PubMed 15859527Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Walking Training and Forward Walking Training in people with Chronic Stroke Patients, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burçin Akçay (+905056533273, akcayburcin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar pressure assessment (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903392, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.