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NCT Number: NCT06914115

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Spasticity, Muscle Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City Rehabilitation Center

Okāra, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TANS Group

Combination 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 Exercise

Combination 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.

Primary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: 12 Months

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

  2. Fugl-Meyer Assessment (FMA)

    Time frame: 12 Months

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

  3. Numeric Rating Scale (NRS)

    Time frame: 12 Months

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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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