Spasticity, Muscle
Conditions
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.
Interventions
COMBINATION_PRODUCTTANS Group
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.
COMBINATION_PRODUCTBody Rocking Exercise
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.
Sponsors
Superior University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Pakistan
Outcome results
None listed