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

Superior University

Status: Active, not recruiting

Conditions: Spasticity, Muscle

Treatments: Combination Product: Body Rocking Exercise; Combination Product: TANS Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06914115

MSRSW/Batch-Fall23/816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

TANS Group

Experimental group

Treatment:

Combination Product: TANS Group

Body Rocking Exercise

Experimental group

Treatment:

Combination Product: Body Rocking Exercise