Clinical trial NCT04597658: The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients
Official title: The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Gait Disorders, Neurologic
Walking, Difficulty
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aimed to evaluate the effects of exercise on body weight-supported treadmill in stroke patients on gait parameters, activity, body functions and quality of life, and to determine whether it has an effect on balance when applied in addition to conventional therapy.

Detailed description: The study was planned as an open, prospective, randomized, single-blind study, and it was planned by the researchers to include 30 patients with stroke who applied to the Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Physical Therapy and Rehabilitation. It was planned that the "Informed Consent Form" prepared before the study would be signed by the patient before being included in the study, and patient evaluation and follow-up forms would be filled in before and after the treatment.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who have had an ischemic or hemorrhagic stroke
* 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 a stroke less than a month
* 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)

Primary outcomes:
measure: Change in The 10 Metre Walk Test
timeFrame: Baseline (before intervention), immediately after intervention
Secondary outcomes:
measure: Change in The Rivermead Mobility Index Score
timeFrame: Baseline (before intervention), immediately after intervention
measure: Change in The 6 Minute Walk Test
timeFrame: Baseline (before intervention), immediately after intervention
measure: Change in Stroke Specific Quality of Life Scale Score
timeFrame: Baseline (before intervention), immediately after intervention
measure: Change in Tinetti Balance and Gait Assessment Score
timeFrame: Baseline (before intervention), immediately after intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatih
Study officials:
affiliation: Istanbul University
name: Elif Tarihçi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.