Clinical trial NCT05183100: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Stroke
Spasticity Post Stroke
Keywords: Neurodynamics
Calf muscle spasticity
Chronic stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Spasticity: Clinical measurement
timeFrame: Before intervention and immediately after intervention
measure: Change in Spasticity: Neurophysiological measurement
timeFrame: Before intervention and immediately after intervention
Secondary outcomes:
measure: Change in Gait Performance
timeFrame: Before intervention and immediately after intervention
measure: Change in Lower Extremity Motor Control
timeFrame: Before intervention and immediately after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ray-Yau Wang
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.