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

NCT05183100 | Completed

• 1 other identifier: YM110045E
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke; Stroke; Spasticity Post Stroke

Keywords

Neurodynamics; Calf muscle spasticity; Chronic stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  Before intervention and immediately after intervention

• 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.

  Before intervention and immediately after intervention

Secondary Outcomes (2)

• Change in Gait Performance

  Before intervention and immediately after intervention

• Change in Lower Extremity Motor Control

  Before intervention and immediately after intervention

Study Arms (2)

Experimental Condition (Neurodynamics Treatment)

EXPERIMENTAL

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

Control Condition

ACTIVE COMPARATOR

Lying in supine.

Procedure: Lying in supine

Interventions

Tibial Nerve Neurodynamics PROCEDURE

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.

Also known as: Tibial Nerve Neural Mobilization

Experimental Condition (Neurodynamics Treatment)

Lying in supine PROCEDURE

Lying in supine position for about 13 minutes.

Control Condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 31655484 BACKGROUND

• 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.

  PMID: 25140078 BACKGROUND

• 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.

  PMID: 31078139 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ray-Yau Wang

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 10, 2022
• Study Start: October 18, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: October 7, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)