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

N/AActive Not RecruitingNCT06914115

Superior University42 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Spasticity, Muscle

Interventions

TANS GroupCOMBINATION_PRODUCT

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.

Body Rocking ExerciseCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

City Rehabilitation Center

Okāra, Sindh, Pakistan

Outcomes

Primary Outcomes

Modified Ashworth Scale (MAS)

Assesses spasticity (0 = no increase, 4 = rigid limb).

Time frame: 12 Months

Fugl-Meyer Assessment (FMA)

Evaluates motor function (0-66, higher = better function).

Time frame: 12 Months

Numeric Rating Scale (NRS)

Measures pain (0 = no pain, 10 = severe pain).

Time frame: 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.