The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients

NCT04597658 | Completed

• 1 other identifier: ITF, PMR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Accident; Gait Disorders, Neurologic; Walking, Difficulty

Outcome Measures

Primary Outcomes (1)

• Change in The 10 Metre Walk Test

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

  Baseline (before intervention), immediately after intervention

Secondary Outcomes (4)

• Change in The Rivermead Mobility Index Score

  Baseline (before intervention), immediately after intervention

• Change in The 6 Minute Walk Test

  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

Study Arms (2)

Conventional rehabilitation

ACTIVE COMPARATOR

Behavioral: Conventional rehabilitation

Body weightsupported treadmill training

EXPERIMENTAL

Behavioral: Bodyweight supported treadmill training (BWSTT)

Interventions

Bodyweight supported treadmill training (BWSTT) BEHAVIORAL

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.

Body weightsupported treadmill training

Conventional rehabilitation BEHAVIORAL

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.

Conventional rehabilitation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 25467394 BACKGROUND

• 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.

  PMID: 28034719 BACKGROUND

• 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.

  PMID: 24519922 BACKGROUND

• 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.

  PMID: 38363446 DERIVED

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elif Tarihçi, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 22, 2020
• Study Start: January 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: May 15, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

TU (1)