The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients
NCT ID: NCT04597658
Last Updated: 2023-11-24
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-01-01
2023-05-15
Brief Summary
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Detailed Description
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Patients who meet the inclusion criteria at the beginning of the study will be numbered according to the order of application and randomly divided into two groups with the computer program. Group number 1 Treadmill with Weight Support; Group number 2 will be determined as the Conventional Rehabilitation group. In addition to the traditional rehabilitation program and rehabilitation program to both groups, one group will be given body weight support and treadmill therapy. The treatment will be applied as 15 sessions 5 days a week.
A traditional rehabilitation program will be applied to both groups. Posture and breathing exercises, lower extremity stretching, active auxiliary range of motion, and strengthening exercises will be applied. Electrical stimulation will not be delivered to the lower limb. Balance coordination exercises - sitting in a chair (individually shaped according to the patient's balance), holding it in a safe place if necessary; standing without support, standing quietly, heel tip, standing on one leg, and holding onto a chair). Patients will be asked to walk on a smooth surface in the company with a physiotherapist, using an assistive device, if any. The rehabilitation program is planned to last 30 minutes in total.
In the group where the bodyweight supported treadmill will be applied, patients will be asked to walk on the treadmill as fast as possible without exceeding the medium intensity according to the Borg scale. - Perceived fatigue on the Borg scale is quite mild 10-12. (40-50% of the maximum heart rate). Care should be taken that the patient wears appropriate shoes and clothing during walking.
In the beginning, 30% of the whole body weight will not be loaded. Bodyweight support will be reduced to 15% according to the tolerance of the patient. Later, when the patients can tolerate the speed of 2km / hour, they will not take more than two breaks during the 30-minute session, and 0% support will be applied when they are able to perform optimal walking without the need for at least 5 minutes of surveillance support. In the treatment to be performed under the guidance of a physiotherapist, manual intervention to the pelvis, trunk, and/or paretic extremity will correct the gait pattern. At the same time, verbal stimulation will ensure that temporal characteristics of the gait such as step length and walking speed are appropriate and at the same time the patient is motivated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional rehabilitation
Conventional rehabilitation
The conventional rehabilitation program includes posture and breathing exercises, lower extremity stretching, active-assistive range of motion and strengthening, balance-coordination exercises, and walking with a physiotherapist on a smooth surface.
Body weightsupported treadmill training
Bodyweight supported treadmill training (BWSTT)
In the BWSTT group, walking training will be given by asking the patients to walk on the treadmill as fast as they can, without exceeding the medium intensity according to the Borg scale. Bodyweight support will be gradually reduced according to the patient's tolerance.
Interventions
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Bodyweight supported treadmill training (BWSTT)
In the BWSTT group, walking training will be given by asking the patients to walk on the treadmill as fast as they can, without exceeding the medium intensity according to the Borg scale. Bodyweight support will be gradually reduced according to the patient's tolerance.
Conventional rehabilitation
The conventional rehabilitation program includes posture and breathing exercises, lower extremity stretching, active-assistive range of motion and strengthening, balance-coordination exercises, and walking with a physiotherapist on a smooth surface.
Eligibility Criteria
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Inclusion Criteria
* A history of the cerebrovascular event
* Patients who can walk 10 meters with or without an assistive device and / or orthosis (Patients with lower extremity motor functions above 2 according to Brunnstrom staging)
* Patients with comfortable walking speed \<1.0 m / s
* Patients who can follow verbal warnings (patients with Mini-mental test score \> 19)
Exclusion Criteria
* Patients with stage 0 (non-functional ambulation) and stage 1 (the person's manual support is continuous) according to the functional ambulation scale
* Presence of serious cardiovascular or respiratory system diseases that prevent exercising
* Presence of uncontrolled metabolic disease (uncontrolled diabetes)
* Participation in an intensive rehabilitation program in the last month and continuing
* Presence of arthritis or severe contracture in the lower limb that may affect walking
* Presence of other accompanying neuromuscular diseases (such as Parkinson's disease)
18 Years
95 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Elif Tarihçi
Principal Investigator
Principal Investigators
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Elif Tarihçi, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University
Locations
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Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, Turkey (Türkiye)
Countries
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References
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Middleton A, Merlo-Rains A, Peters DM, Greene JV, Blanck EL, Moran R, Fritz SL. Body weight-supported treadmill training is no better than overground training for individuals with chronic stroke: a randomized controlled trial. Top Stroke Rehabil. 2014 Nov-Dec;21(6):462-76. doi: 10.1310/tsr2106-462.
Gama GL, Celestino ML, Barela JA, Forrester L, Whitall J, Barela AM. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017 Apr;98(4):738-745. doi: 10.1016/j.apmr.2016.11.022. Epub 2016 Dec 27.
Combs-Miller SA, Kalpathi Parameswaran A, Colburn D, Ertel T, Harmeyer A, Tucker L, Schmid AA. Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial. Clin Rehabil. 2014 Sep;28(9):873-84. doi: 10.1177/0269215514520773. Epub 2014 Feb 11.
Tarihci Cakmak E, Yaliman A, Torna G, Sen EI. The effectiveness of bodyweight-supported treadmill training in stroke patients: randomized controlled trial. Neurol Sci. 2024 Jul;45(7):3277-3285. doi: 10.1007/s10072-024-07385-z. Epub 2024 Feb 16.
Other Identifiers
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ITF, PMR
Identifier Type: -
Identifier Source: org_study_id