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NCT Number: NCT07619586

Lumbar Spinal Manipulation in Stroke

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Bolu, Merkez, 14280, Turkey (Türkiye)

Location contact

Birkan Özkardaş, Mr.

CONTACT

[email protected]

5550639585 ext. +90

Burak Mavuş, M.Sc.

CONTACT

[email protected]

5388178351 ext. +90

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lumbar Spinal Manipulation

Other

This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.

Placebo Lumbar Spinal Manipulation

Other

This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Mavuş, M.Sc.

CONTACT

[email protected]

5388178351 ext. +90

Ömer Dursun, Assoc. Prof.

CONTACT

[email protected]

05426088687

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Jun 16, 2026

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.

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