Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb

Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb in Young Stroke Patients

The primary aim of this study is to compare the effect of TANS and body rocking exercises on reducing upper limb spasticity in young stroke patients( under 50). Specific objectives include evaluating changes in muscle tone, motor function, pain reduction, and functional independence following each intervention.

Study Overview

• Status: Active, not recruiting
• Conditions: Spasticity, Muscle
• Intervention / Treatment: Combination product: TANS Group; Combination product: Body Rocking Exercise

Detailed Description

This randomized controlled trial, RCT, will involve 42 young stroke patients with upper limb spasticity randomly assigned to three groups, transcutaneous auricular nerve stimulation, body rocking exercise, or control group, usually rehabilitation. Participants will receive 30-minute transcutaneous nerve stimulation session or 20 to 30-minute body rocking exercise in session 3 to 4 times a week over an 8-week period. Key outcome measures include the Modified Ashworth Scale for Spasticity, the Fusel-Meyer Assessment for Motor Function, the Numeric Rating Scale for Pain, and Stroke Impact Scale for Functional Independence.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Okāra, Sindh, Pakistan
      • City Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 35-50 years
• Diagnosed with stroke (ischemic or hemorrhagic)
• Upper limb spasticity (Modified Ashworth Scale score ≥1)
• Post-stroke duration of ≥3 months
• Able to follow verbal and physical instructions
• No contraindications to electrical stimulation or exercise therapy

Exclusion Criteria:

• Severe cognitive impairment or communication disorders
• History of epilepsy or uncontrolled seizures
• Pacemaker or implanted medical devices
• Severe cardiac, orthopedic, or neurological conditions
• Uncontrolled hypertension or diabetes
• Participation in another spasticity-related trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TANS Group	Combination product: TANS Group; The TANS Group will receive low-frequency electrical stimulation (20-30 Hz) via a TENS device on the auricular vagus nerve for 30 minutes, 3-4 times per week for 8 weeks. This non-invasive therapy aims to reduce spasticity, enhance neuroplasticity, and improve motor function and independence, assessed through standardized scales.
Experimental: Body Rocking Exercise	Combination product: Body Rocking Exercise; Group 2: Body Rocking Exercise Group Participants will perform rhythmic body rocking exercises for 20-30 minutes, 3-4 times per week for 8 weeks to reduce spasticity and improve motor coordination. Group 3: Control Group (Usual Rehabilitation) Participants will receive standard stroke rehabilitation (therapy, stretching, functional training) for 20-30 minutes, 3-4 times per week for 8 weeks as a baseline comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS)	Assesses spasticity (0 = no increase, 4 = rigid limb).	12 Months
Fugl-Meyer Assessment (FMA)	Evaluates motor function (0-66, higher = better function).	12 Months
Numeric Rating Scale (NRS)	Measures pain (0 = no pain, 10 = severe pain).	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Mental Disorders; Neurodevelopmental Disorders; Muscle Spasticity; Stereotypic Movement Disorder
• Other Study ID Numbers: MSRSW/Batch-Fall23/816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No