Talocrural Joint Manipulation in Stroke

Bitlis Eren University

Status: Completed

Conditions: Stroke

Treatments: Other: Placebo Talocrural Joint Manipulation; Other: Talocrural Joint Manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06523010

BEUFTR-5

Details and patient eligibility

About

The primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. The secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with 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 talocrural joint manipulation and talocrural joint manipulation treatments.

Enrollment: 64 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Two months or longer elapsed since the stroke,
• 2. A Mini-Mental State Examination score of 24 or higher,
• 3. The ability to stand independently for 20 seconds or more,
• 4. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
• 5. Being between 45 and 75 years of age,
• 6. Having a Brunnstrom stage of 4 or above

Exclusion criteria

• 1. The presence of severe osteoarthritis in the lower extremity,
• 2. The presence of cancer or diabetic neuropathy,
• 3. The presence of vestibular disorder,
• 4. The presence of lower extremity ulceration or amputation,
• 5. History of vertigo,
• 6. Alcohol consumption within the last 24 hours,
• 7. Hemodynamic instability,
• 8. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
• 9. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
• 10. Having experienced an acute lower extremity injury in the last six weeks,
• 11. History of lower extremity surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Placebo Talocrural Joint Manipulation Group

Placebo Comparator group

Description:

Each group will receive both placebo and real talocrural joint manipulations in a randomized cross-over design. There will be a minimum interval of 48 hours between the interventions. Data obtained after the real manipulation will be recorded as the placebo comparator group data.

Treatment:

Other: Talocrural Joint Manipulation

Other: Placebo Talocrural Joint Manipulation

Talocrural Joint Manipulation Group

Active Comparator group

Description:

Each group will receive both placebo and real talocrural joint manipulations in a randomized cross-over design. There will be a minimum interval of 48 hours between the interventions. Data obtained after the real manipulation will be recorded as the active comparison group data.

Treatment:

Other: Talocrural Joint Manipulation

Other: Placebo Talocrural Joint Manipulation