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

October 6, 2022 updated by: National Yang Ming University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112304
        • National Yang Ming Chiao Tung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Condition (Neurodynamics Treatment)
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.
Procedure: Tibial Nerve Neurodynamics
The patient will lie supine with the trunk and neck in neutral position. During the first stage, participants will receive passive straight leg raise of the affected side held for 20 seconds for 3 repetitions. In the second stage, hip adduction and internal rotation, ankle dorsiflexion, and ankle eversion are added in the straight leg raise position. Slow oscillations of the ankle movement for 1 minute will be applied, followed by holding the position for 20 seconds, for 3 repetitions. In the third stage, the head of the patient will be held in flexion with pillows while the same oscillation procedure as the second stage is performed. There will be a 2-minute rest between the stages.
Other Names:
  • Tibial Nerve Neural Mobilization
Active Comparator: Control Condition
Lying in supine.
Procedure: Lying in supine
Lying in supine position for about 13 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before intervention and immediately after intervention
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.
Before intervention and immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gait Performance
Time Frame: 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.
Before intervention and immediately after intervention
Change in Lower Extremity Motor Control
Time Frame: 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.
Before intervention and immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Investigators

  • Principal Investigator: Ray-Yau Wang, National Yang Ming Chiao Tung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2021

Primary Completion (Actual)

January 26, 2022

Study Completion (Actual)

January 26, 2022

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YM110045E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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