Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Stroke; Spasticity Post Stroke; Chronic Stroke

Treatments: Procedure: Lying in supine; Procedure: Tibial Nerve Neurodynamics

Study type: Interventional

Funder types: Other

Identifiers

NCT05183100

YM110045E

Details and patient eligibility

About

Post-stroke spasticity in the lower extremity affects balance and gait, leading to decreased mobility and functional independence. Therefore, effective intervention for reducing spasticity is crucial in stroke rehabilitation. Recently, neurodynamics, though originally designed for pain management in orthopedic patients, has also been applied for treating spasticity in patients with neurological disorders. However, previous studies focused mainly on treating the upper extremity spasticity, but not on lower extremity spasticity, and not on possible neurophysiological changes. The present study aims to investigate the immediate effects of neurodynamics in reducing lower limb spasticity and neurophysiological changes in people with chronic stroke.

Full description

Sample size calculation: There was no reference for the effect size of neurodymanics on reducing lower extremity spasticity, and the effect size of neurodynamics treatment for improving knee range of motion was between 0.89 to 2.55. We set the effect size of 0.6 (moderate effect size) with an alpha level of 5%, power at 80%, and a paired t-test model to calculate the sample size.

Statistical analysis: Paired t-test will be used for within condition (experimental or control condition) comparisons. The change values between pre and post in each condition will be calculated and compared by paired t-test for between condition comparisons. The significance is set at p< 0.05.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of first-ever stroke with unilateral lesion for more than 6 months
• demonstrating calf muscle spasticity as indicated by modified Ashworth scale equal to or greater than 1
• with passive ROM of ankle dorsiflexion at least to neutral position (defined as 0°)
• ability to walk at least 10m independently without a walking device or ankle-foot orthosis (AFO)
• sufficient cognition (mini-mental state examination, MMSE score of 24 or higher)

Exclusion criteria

• contraindications to nerve conduction tests
• other orthopedic and neurological disorders interfering participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Experimental Condition (Neurodynamics Treatment)

Experimental group

Description:

Neurodynamic treatment for about 13 minutes in supine position. It will be comprised of three stages, and the tensioner technique of the tibial nerve will be used.

Treatment:

Procedure: Tibial Nerve Neurodynamics

Control Condition

Active Comparator group

Description:

Lying in supine.

Treatment:

Procedure: Lying in supine