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

Not Applicable

Completed

• Conditions: Stroke; Chronic Stroke; Spasticity Post Stroke

• Registration Number: NCT05183100
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-18
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-10
• Primary Completion: 2022-01-26
• Study Completion: 2022-01-26
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Spasticity: Neurophysiological measurement	Before intervention and immediately after intervention	The H-reflex will be recorded by placing a disposable surface electrode on the muscle belly of the gastrocnemius after a stimulation of the tibial nerve just proximal to the electrode.
Change in Spasticity: Clinical measurement	Before intervention and immediately after intervention	The modified Ashworth scale (MAS) will be used, which is a 6-point scale commonly used to assess muscle spasticity in clinical settings.

Secondary Outcome Measures

Name	Time	Method
Change in Gait Performance	Before intervention and immediately after intervention	Gait performance will be measured by using the GAITRite system (CIR system, Inc., Havertown, Pennsylvania). Participants will be instructed to walk along the walkway at their comfortable speed. Gait velocity, cadence, and step length of the affected and unaffected limbs, and spatial and temporal asymmetry ratios are calculated.
Change in Lower Extremity Motor Control	Before intervention and immediately after intervention	Motor control of the lower extremity will be assessed by the motor section of the Fugl-Meyer Assessment (FMA). Higher scores represent better motor control, with a total score of 34.

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan