NCT04816929

Brief Summary

Trunk impairment and asymmetry that occur after stroke negatively affect many functional activities in the daily lives of patients. There are different neurophysiological approaches such as Bobath method and task-oriented approach used in post-stroke rehabilitation programs in the literature. However, there are not many studies that comprehensively evaluate and compare the effects of these neurophysiological approaches on trunk muscles, balance and gait in stroke patients. The aim of this study is to examine and compare the effects of Bobath method and task-oriented approach on architectural features and activation of trunk muscles and functional performance in stroke patients. In addition, this study will demonstrate with muscle thickness and activation the asymmetry that may occur between the hemiparetic and non-paretic trunk muscles of stroke patients, and will allow examining the effects of these features on functional performance. This study was planned to include two treatment groups. The Bobath group will receive Bobath based trunk, balance and walking exercises, while the task-oriented group will receive exercises for oriented task. Trunk impairment, motor functions, thickness and activation of trunk muscles, spatio-temporal parameters of gait, balance and goal attainment will be assessed before and after 8 weeks treatment program. As a result; effectiveness of Bobath method and task-oriented approach will be compared and relationship between muscle thickness, activation and functional performance will be examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

March 21, 2021

Last Update Submit

April 16, 2023

Conditions

Keywords

StrokeCerebrovascular DisordersTrunkMuscle ThicknessUltrasonographyMuscle ActivationElectromyographyGaitBalance

Outcome Measures

Primary Outcomes (4)

  • Evaluation of Muscle Thickness with Ultrasonography

    The evaluation of muscle thickness of bilateral rectus abdominis, external oblique, latissimus dorsi and erector spinae with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK) in resting position. Muscle Thickness would be expressed as centimeters.

    change from baseline in muscle thickness of trunk muscles at 8 weeks

  • Evaluation of Muscle Activation with Superficial Electromyography

    The evaluation of muscle activation of bilateral rectus abdominis, external oblique, latissimus dorsi and erector spinae will be performed using Delsys Trigno Superficial Electromyography System during maximum voluntary isometric contraction, gait and balance performance.

    change from baseline in muscle activation of trunk muscles at 8 weeks

  • Evaluation of Spatio-Temporal Parameters of Gait with GAITRite Analysis System

    The evaluation of spatio-temporal parameters of gait such as velocity, cadence, step time, step length, gait cycle in double and single support, stance phase, swing phase, base of support, gait symmetry will be performed using the GAITRite electronic walkway.

    change from baseline in spatio-temporal parameters of gait at 8 weeks

  • Evaluation of Balance

    The evaluation of limits of stability, anteroposterior and mediolateral sway range will be performed using the Bertec Balance Check ScreenerTM force platform system.

    change from baseline in balance at 8 weeks

Secondary Outcomes (3)

  • Trunk Impairment Scale

    change from baseline in trunk performance at 8 weeks

  • Stroke Rehabilitation Assessment of Movement

    change from baseline in motor function at 8 weeks

  • Goal Attainment Scaling

    change in satisfaction regarding how to reach the goals related exercise therapy at 8 weeks

Study Arms (2)

Bobath Method Group

EXPERIMENTAL

The Bobath based exercises for 60 minutes will be formed according to the needs of the individual and will involve trunk exercises such as placing, stretching, functional reach, rotations, functional strengthening and, balance and walking exercises etc. It will be performed 3 days a week for 8 weeks.

Other: Bobath Method

Task-Oriented Approach Group

ACTIVE COMPARATOR

The task-oriented approach for 60 minutes will be formed according to the needs of the individual and involve exercises targeting functional tasks determined. It will be performed 3 days a week for 8 weeks.

Other: Task-Oriented Approach

Interventions

Neurodevelopmental Treatment

Bobath Method Group

Task-Oriented Treatment

Task-Oriented Approach Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral stroke for more than 3 months
  • Being over the age of 18
  • Having trunk impairment (not having full points in the Trunk Impairment Scale)
  • Being able to walk without support or with walking aid.

You may not qualify if:

  • Having recurrent stroke
  • Having an orthopedic or neurological disorders other than stroke that may affect motor performance
  • Having a cognitive problem (Not having Mini Mental State Examination score ≥ 24)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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

March 21, 2021

First Posted

March 25, 2021

Study Start

January 18, 2021

Primary Completion

April 20, 2022

Study Completion

April 20, 2022

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations