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

Not Applicable

Active, not recruiting

• Conditions: Spasticity, Muscle

• Registration Number: NCT06914115
• Lead Sponsor: Superior University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

City Rehabilitation Center; 🇵🇰 Okāra, Sindh, Pakistan