Skip to main content
OpenTrials
Completed

NCT Number: NCT03429855

Bobath Approach for Trunk Control in Acute Stroke Patients

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

42 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. Trunk control is an important issue in the Bobath approach since the acute period. It seems that the Bobath method, which includes both approaches to increase postural control and sitting, as well as applications to increase the sensation, seems to be an appropriate method to improve body control in stroke patients. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training in acute stroke. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients scoring ≥14 on Glasgow Coma Scale and Mini Mental Test>24

Exclusion criteria

  • patients scoring <14 on Glasgow Coma Scale
  • patients with recurrent strokes
  • patients with orthopedic or neurological disorders (other than strokes) that might affect their motor performance

Treatment and study plan

Trunk training

Other

Bobath based trunk training

Physiotherapy

Other

conventional physiotherapy

Primary outcomes

  1. Trunk Impairment Scale (by Verheyden)

    Time frame: Change from Baseline the scale score at 20th days in hospital

    It consists of 3 subscales of static and dynamic sitting balance and trunk coordination, scored up to 7, 10, and 6 points, respectively.The total scores range between 0 and 23 points, where a higher score indicates better truncal function.

  2. Trunk Control Test

    Time frame: Change from Baseline the scale score at 20th days in hospital

    The test consists of four items which are assessed on a 3-point ordinal scale.The total score for the Trunk Control Test ranges from minimum 0 to maximum 100 points, a higher score indicating a better performance.

  3. Motor Assessment Scale

    Time frame: Change from Baseline the scale score at 20th days in hospital

    It contains three items assessing trunk performance. Each item is scored on a 7-point ordinal scale, a higher score indicating a better performance.

  4. Berg Balance Scale

    Time frame: Change from Baseline the scale score at 20th days in hospital

    The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. The BBS has been evaluated in several reliability studies.

  5. independently sitting time

    Time frame: Change from Baseline sitting time at 20th days in hospital

    Sitting with back unsupported without using hands but feet supported on floor.

Secondary outcomes

  1. Glasgow Coma Scale

    Time frame: Baseline, on 7th, 10th and 20th days during the treatment

    It assessed the initial and subsequent level of consciousness in a person after a brain injury. Mild head injuries are generally defined as those associated with a Glasgow Coma scale score of 13-15.

  2. Modified Rankin Scale

    Time frame: Baseline, on 7th, 10th and 20th days during the treatment

    The Modified Rankin Scale (MRS) is the most commonly used to evaluate the degree of disability or dependence in the daily activities of people who have suffered a stroke. It describes "global disability" with a focus on mobility. The MRS is an ordered scale coded from 0 (no symptoms at all) through 5 (severe disability) 6 (death).

  3. The Functional Independence Measure (FIM)

    Time frame: Baseline, on 7th, 10th and 20th days during the treatment

    The Functional Independence Measure (FIM) evaluates self-care, sphincter control, mobility, locomotion, communication, and social cognition. The FIM item scores range from 1 (total assistance required) to 7 (complete independence). A higher score indicates a greater degree of independence with regard to daily living activities. This subscale has good psychometric properties for stroke patients.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effectiveness of Bobath Based Trunk Training on in Acute Stroke Patients: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.