Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05183100
Other study ID # YM110045E
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis