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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183100
• Other study ID #: YM110045E
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: October 2021
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Muscle Spasticity
• Stroke

Intervention

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.
• Lying in supine
Lying in supine position for about 13 minutes.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. — View Citation

López López L, Torres JR, Rubio AO, Torres Sánchez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Before intervention and immediately after intervention
Secondary	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.	Before intervention and immediately after intervention