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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05183100
Enrollment
15
Registered
2022-01-10
Start date
2021-10-18
Completion date
2022-01-26
Last updated
2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke, Spasticity Post Stroke, Stroke

Keywords

Neurodynamics, Calf muscle spasticity, Chronic stroke

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.

Interventions

PROCEDURETibial 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.

PROCEDURELying in supine

Lying in supine position for about 13 minutes.

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Spasticity: Clinical measurementBefore intervention and immediately after interventionThe 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 measurementBefore intervention and immediately after interventionThe 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

MeasureTime frameDescription
Change in Gait PerformanceBefore intervention and immediately after interventionGait 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 ControlBefore intervention and immediately after interventionMotor 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026