Thoracic Spinal Manipulation in Stroke

May 23, 2026 updated by: Omer Dursun, Bitlis Eren University

Effects of Thoracic Spinal Manipulation on Balance, Fall Risk, and Thoracic Mobility in Patients With Chronic Stroke: A Randomized Crossover Trial

The aim of the study is to investigate the effects of thoracic spinal manipulation on balance, fall risk, and thoracic mobility of the patients with chronic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive both placebo thoracic spinal manipulation and thoracic spinal manipulation interventions.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Bolu, Merkez, Turkey (Türkiye), 14280
        • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having chronic stroke,
  • A Mini-Mental State Examination score of 24 or higher,
  • Ability to stand independently for 20 seconds or more,
  • Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
  • Being between 40 and 75 years of age,
  • Having a Brunnstrom stage of 4 or above

Exclusion Criteria:

  • History of whiplash injury,
  • Diagnosis of fibromyalgia,
  • History of spinal manipulation treatment within the previous 2 months,
  • History of cervical or thoracic fracture or dislocation,
  • History of cervical or thoracic spine surgery,
  • Diagnosis of cervical radiculopathy or myelopathy,
  • Presence of serious spinal pathology,
  • Presence of any orthopedic or neurological disorder other than stroke, or an unstable cardiac condition,
  • Presence of a vestibular disorder,
  • The presence of lower extremity ulceration or amputation,
  • Alcohol consumption in the last 24 hours,
  • Posterior circulation stroke involving the basilar artery or cerebellum,
  • Having experienced an acute lower extremity injury in the last six weeks,
  • History of lower extremity surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PlaceboThoracic Spinal Manipulation Group
Participants will receive placebo thoracic manipulation in the first session and thoracic spinal manipulation after a one-week washout period.
Other: Thoracic Spinal Manipulation
This technique is based on the application of a high-velocity, low-amplitude force to the thoracic spine with the aim of increasing thoracic mobility.
Other: Placebo Thoracic Spinal Manipulation
This intervention is a classic method used to evaluate the effect of thoracic spinal manipulation.
Active Comparator: Thoracic Spinal Manipulation Group
Participants will receive thoracic spinal manipulation in the first session and placebo thoracic manipulation after a one-week washout period.
Other: Thoracic Spinal Manipulation
This technique is based on the application of a high-velocity, low-amplitude force to the thoracic spine with the aim of increasing thoracic mobility.
Other: Placebo Thoracic Spinal Manipulation
This intervention is a classic method used to evaluate the effect of thoracic spinal manipulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Postural Stability Index Measurement
Time Frame: Change from baseline overall postural stability index immediately after the intervention
This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Change from baseline overall postural stability index immediately after the intervention
Fall Risk Assessment
Time Frame: Change from baseline overall postural stability index immediately after the intervention
Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform. Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling. The test will be performed with two 30-second trials. The average of the three trials will be calculated automatically by the TechnoBody balance system.
Change from baseline overall postural stability index immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anteroposterior Stability Index Measurement
Time Frame: Change from baseline overall postural stability index immediately after the intervention
The anteroposterior stability index will be assessed by measuring deviations of the center of gravity in the anteroposterior direction. Lower scores indicate smaller deviations and better anteroposterior postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Change from baseline overall postural stability index immediately after the intervention
Mediolateral Stability Index Measurement
Time Frame: Change from baseline mediolateral stability index immediately after the intervention
The mediolateral stability index will be assessed by measuring deviations of the center of gravity in the mediolateral direction. Lower scores indicate smaller deviations and better mediolateral postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Change from baseline mediolateral stability index immediately after the intervention
Thoracic Mobility
Time Frame: Change from baseline mediolateral stability index immediately after the intervention
Thoracic mobility will be assessed by measuring trunk rotation and lateral flexion using a smartphone inclinometer positioned at the level of T2.
Change from baseline mediolateral stability index immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Investigators

  • Principal Investigator: Burak Mavuş, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
  • Principal Investigator: Merve Tunçdemir, Asst. Prof., Bitlis Eren University
  • Principal Investigator: Ömer Dursun, Assoc. Prof., Bitlis Eren University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Actual)

May 22, 2026

Study Completion (Actual)

May 22, 2026

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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