Lumbar Spinal Manipulation in Stroke

Bitlis Eren University

Status: Begins enrollment in 2 months

Conditions: Stroke

Treatments: Other: Lumbar Spinal Manipulation; Other: Placebo Lumbar Spinal Manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07619586

BEUFTR-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

52 participants in 2 patient groups, including a placebo group

Placebo Comparator: Placebo Lumbar Spinal Manipulation Group

Placebo Comparator group

Description:

Participants will receive placebo lumbar spinal manipulation in the first session and lumbar spinal manipulation after a washout period.

Treatment:

Other: Placebo Lumbar Spinal Manipulation

Other: Lumbar Spinal Manipulation

Active Comparator: Lumbar Spinal Manipulation Group

Active Comparator group

Description:

Participants will receive lumbar spinal manipulation in the first session and placebo lumbar spinal manipulation after a washout period.

Treatment:

Other: Placebo Lumbar Spinal Manipulation

Other: Lumbar Spinal Manipulation