Spasticity, MuscleNCT06914115
Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb
A study testing TANS Group and Body Rocking Exercise in people with Spasticity, Muscle, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- TANS Group and Body Rocking Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb in Young Stroke Patients
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.
Read the 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.
- Conditions
- Spasticity, Muscle
- Being tested
- TANS Group, Body Rocking Exercise
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TANS GroupCombination 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 ExerciseCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| TANS Group | Experimental | Not described Receives: Combination Product: TANS Group |
| Body Rocking Exercise | Experimental | Not described Receives: Combination Product: Body Rocking Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
Assesses spasticity (0 = no increase, 4 = rigid limb).
Measured: 12 Months
Fugl-Meyer Assessment (FMA)
Evaluates motor function (0-66, higher = better function).
Measured: 12 Months
Numeric Rating Scale (NRS)
Measures pain (0 = no pain, 10 = severe pain).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914115
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/816
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb in Young Stroke Patients
- ClinicalTrials.gov ID
- NCT06914115
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/816
- Conditions
- Spasticity, Muscle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TANS Group | Experimental | Combination Product: TANS Group |
| Body Rocking Exercise | Experimental | Combination Product: Body Rocking Exercise |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TANS GroupThe 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 product | TANS Group |
| Body Rocking ExerciseGroup 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. | Combination product | Body Rocking Exercise |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Spasticity, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TANS Group and Body Rocking Exercise in people with Spasticity, Muscle, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.