Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2025
CompletedFirst Submitted
Initial submission to the registry
March 29, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2026
CompletedApril 6, 2025
March 1, 2025
3 months
March 29, 2025
March 29, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Modified Ashworth Scale (MAS)
Assesses spasticity (0 = no increase, 4 = rigid limb).
12 Months
Fugl-Meyer Assessment (FMA)
Evaluates motor function (0-66, higher = better function).
12 Months
Numeric Rating Scale (NRS)
Measures pain (0 = no pain, 10 = severe pain).
12 Months
Study Arms (2)
TANS Group
EXPERIMENTALBody Rocking Exercise
EXPERIMENTALInterventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City Rehabilitation Center
Okāra, Sindh, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 29, 2025
First Posted
April 6, 2025
Study Start
March 20, 2025
Primary Completion
June 20, 2025
Study Completion
February 20, 2026
Last Updated
April 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share