NCT04903392

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

May 18, 2021

Last Update Submit

March 13, 2022

Conditions

Keywords

Chronic Stroke PatientsBalancePlantar Pressure DistributionRespiratory ParametersBackward Gait Training

Outcome Measures

Primary Outcomes (8)

  • 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 (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

  • 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

Study Arms (2)

Backward Walking Group

EXPERIMENTAL

Conventional therapy + Backward Walking Training

Other: Backward Walking Training

Forward Walking Group

OTHER

Conventional therapy + Forward Walking Training

Other: Forward Walking Training

Interventions

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

Backward Walking Group

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

Forward Walking Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burçin Akçay

Balıkesir, 10200, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28759977BACKGROUND
  • 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.

    PMID: 32508341BACKGROUND
  • 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.

    PMID: 14667946BACKGROUND
  • 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.

    PMID: 17198591BACKGROUND
  • 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.

    PMID: 15859527BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 26, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations