Lumbar Spinal Manipulation in Stroke

May 26, 2026 updated by: Omer Dursun, Bitlis Eren University

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

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

Study Overview

Status

Not yet recruiting

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 lumbar spinal manipulation and lumbar spinal manipulation interventions.

Study Type

Interventional

Enrollment (Estimated)

52

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 Contact

Study Contact Backup

Study Locations

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

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,
  • Being between 18 and 75 years of age,
  • Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
  • Daily blood pressure not exceeding 140/90 mmHg (or controlled with antihypertensive medication)

Exclusion Criteria:

  • Presence of severe cardiac, pulmonary, hepatic, or renal dysfunction,
  • Presence of severe bone or joint disease, particularly affecting the spine,
  • Presence of risk factors for osteoporosis, especially involving the spine,
  • Orthopedic conditions limiting spinal rotation,
  • History of cancer or diabetic neuropathy,
  • Presence of vestibular disorders,
  • Presence of lower extremity ulceration or amputation,
  • Alcohol consumption within the last 24 hours,
  • Hemodynamic instability,
  • Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
  • Presence of neurological diseases such as multiple sclerosis or Parkinson's disease,
  • History of acute lower extremity injury within the last 6 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: Placebo Comparator: Placebo Lumbar Spinal Manipulation Group
Participants will receive placebo lumbar spinal manipulation in the first session and lumbar spinal manipulation after a washout period.
Other: Lumbar Spinal Manipulation
This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
Other: Placebo Lumbar Spinal Manipulation
This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.
Active Comparator: Active Comparator: Lumbar Spinal Manipulation Group
Participants will receive lumbar spinal manipulation in the first session and placebo lumbar spinal manipulation after a washout period.
Other: Lumbar Spinal Manipulation
This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
Other: Placebo Lumbar Spinal Manipulation
This intervention is a classic method used to evaluate the effect of lumbar 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 three 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 fall risk 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 three 30-second trials. The average of the three trials will be calculated automatically by the TechnoBody balance system.
Change from baseline fall risk immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anteroposterior Stability Index Measurement
Time Frame: Change from baseline anteroposterior 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 three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Change from baseline anteroposterior 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 three 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

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 (Estimated)

August 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-12

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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