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Clinical Trials/NCT04597658
NCT04597658
Completed
N/A

The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients: Randomized Controlled Study

Istanbul University1 site in 1 country30 target enrollmentJanuary 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Istanbul University
Enrollment
30
Locations
1
Primary Endpoint
Change in The 10 Metre Walk Test
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
May 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif Tarihçi

Principal Investigator

Istanbul University

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)

Outcomes

Primary Outcomes

Change in The 10 Metre Walk Test

Time Frame: Baseline (before intervention), immediately after intervention

The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance.

Secondary Outcomes

  • Change in The Rivermead Mobility Index Score(Baseline (before intervention), immediately after intervention)
  • Change in Stroke Specific Quality of Life Scale Score(Baseline (before intervention), immediately after intervention)
  • Change in Tinetti Balance and Gait Assessment Score(Baseline (before intervention), immediately after intervention)
  • Change in The 6 Minute Walk Test(Baseline (before intervention), immediately after intervention)

Study Sites (1)

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