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

Primary Purpose

Chronic Stroke, Stroke, Spasticity Post Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tibial Nerve Neurodynamics
Lying in supine
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Neurodynamics, Calf muscle spasticity, Chronic stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Yang Ming Chiao Tung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Condition (Neurodynamics Treatment)

Control Condition

Arm 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.

Lying in supine.

Outcomes

Primary Outcome Measures

Change in Spasticity: Clinical measurement
The modified Ashworth scale (MAS) will be used, which is a 6-point scale commonly used to assess muscle spasticity in clinical settings.
Change in Spasticity: Neurophysiological measurement
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.

Secondary Outcome Measures

Change in Gait Performance
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
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.

Full Information

First Posted
December 5, 2021
Last Updated
October 6, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05183100
Brief Title
Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke
Official Title
Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Stroke, Spasticity Post Stroke
Keywords
Neurodynamics, Calf muscle spasticity, Chronic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Condition (Neurodynamics Treatment)
Arm Type
Experimental
Arm 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.
Arm Title
Control Condition
Arm Type
Active Comparator
Arm Description
Lying in supine.
Intervention Type
Procedure
Intervention Name(s)
Tibial Nerve Neurodynamics
Other Intervention Name(s)
Tibial Nerve Neural Mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lying in supine
Intervention Description
Lying in supine position for about 13 minutes.
Primary Outcome Measure Information:
Title
Change in Spasticity: Clinical measurement
Description
The modified Ashworth scale (MAS) will be used, which is a 6-point scale commonly used to assess muscle spasticity in clinical settings.
Time Frame
Before intervention and immediately after intervention
Title
Change in Spasticity: Neurophysiological measurement
Description
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.
Time Frame
Before intervention and immediately after intervention
Secondary Outcome Measure Information:
Title
Change in Gait Performance
Description
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.
Time Frame
Before intervention and immediately after intervention
Title
Change in Lower Extremity Motor Control
Description
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.
Time Frame
Before intervention and immediately after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang
Organizational Affiliation
National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112304
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31655484
Citation
Lopez Lopez L, Torres JR, Rubio AO, Torres Sanchez I, Cabrera Martos I, Valenza MC. Effects of neurodynamic treatment on hamstrings flexibility: A systematic review and meta-analysis. Phys Ther Sport. 2019 Nov;40:244-250. doi: 10.1016/j.ptsp.2019.10.005. Epub 2019 Oct 15.
Results Reference
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PubMed Identifier
25140078
Citation
Cha HK, Cho HS, Choi JD. Effects of the nerve mobilization technique on lower limb function in patients with poststroke hemiparesis. J Phys Ther Sci. 2014 Jul;26(7):981-3. doi: 10.1589/jpts.26.981. Epub 2014 Jul 30.
Results Reference
background
PubMed Identifier
31078139
Citation
Datta Gupta A, Visvanathan R, Cameron I, Koblar SA, Howell S, Wilson D. Efficacy of botulinum toxin in modifying spasticity to improve walking and quality of life in post-stroke lower limb spasticity - a randomized double-blind placebo controlled study. BMC Neurol. 2019 May 11;19(1):96. doi: 10.1186/s12883-019-1325-3.
Results Reference
background

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

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