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Clinical Trials/NCT05183100
NCT05183100
Completed
Not Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country15 target enrollmentOctober 18, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
National Yang Ming Chiao Tung University
Enrollment
15
Locations
1
Primary Endpoint
Change in Spasticity: Neurophysiological measurement
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2021
End Date
January 26, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Spasticity: Neurophysiological measurement

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in Gait Performance(Before intervention and immediately after intervention)
  • Change in Lower Extremity Motor Control(Before intervention and immediately after intervention)

Study Sites (1)

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