Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb in Young Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Superior University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Modified Ashworth Scale (MAS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TANS Group
Intervention: TANS Group (Combination Product)
Body Rocking Exercise
Intervention: Body Rocking Exercise (Combination Product)
Outcomes
Primary Outcomes
Modified Ashworth Scale (MAS)
Time Frame: 12 Months
Assesses spasticity (0 = no increase, 4 = rigid limb).
Fugl-Meyer Assessment (FMA)
Time Frame: 12 Months
Evaluates motor function (0-66, higher = better function).
Numeric Rating Scale (NRS)
Time Frame: 12 Months
Measures pain (0 = no pain, 10 = severe pain).
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Naveed Babur
Principal Investigator
Superior University