- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06856473
Effects of Dry Needling on Spasticity and Functional Ability
Effects of Dry Needling on Spasticity and Functional Ability in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Spasticity is a common impairment in individuals with neuromuscular disorders, often leading to limitations in movement, balance, and overall functional performance. Dry needling has emerged as a promising intervention for managing spasticity by targeting hyperactive muscle fibers and reducing abnormal muscle tone. This study aims to explore the therapeutic effects of dry needling on muscle spasticity and functional ability using standardized clinical measures.
Participants will undergo pre- and post-intervention assessments using the Modified Ashworth Scale (MAS) to quantify changes in muscle tone, the Timed Up and Go (TUG) test to evaluate mobility and balance, and the Gross Motor Function Measure (GMFM) to assess functional motor skills. The intervention will focus on specific muscle groups affected by spasticity.
By analyzing the relationship between changes in spasticity and functional mobility, this study seeks to determine whether dry needling contributes to measurable improvements in movement efficiency, postural control, and daily functional activities. The findings will provide valuable insights into the role of dry needling as an adjunct therapy in rehabilitation programs, supporting its integration into clinical practice for individuals with neuromuscular disorders.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jeddah, Saudi Arabia
- BMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hypertonia score 2 according to MAS
- Able to understand and follow instructions
- Able to stand and walk independantly
Exclusion Criteria:
- Participants with neurological conditions that involve significant cognitive deficits or severe uncontrolled epilepsy
- Participants who have undergone surgical procedures within the last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional physical therapy Group
Traditional physical therapy program based on neurodevelopmental treatment (NDT) (3 sessions per week, each lasting 1 hour).
|
Traditional Physical Therapy based on neurodevelopmental technique
Other Names:
|
|
Experimental: Dry needling Group
traditional physical therapy program based on neurodevelopmental Treatment (NDT) (3 sessions per week, each lasting 1 hour), in addition to dry needling for the spastic calf and adductor muscles.
|
Traditional Physical Therapy based on neurodevelopmental technique
Other Names:
Dry Needling in addition to the same traditional physical therapy program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashwarth Scale (MAS)
Time Frame: Week 12 after intervention completion
|
The MAS measures spasticity on a 6-point ordinal scale from 0 to 4, with an additional 1+ category.
Minimum Value (0): No increase in muscle tone (better outcome).
Maximum Value (4): Affected part(s) rigid in flexion or extension (worse outcome).
Higher scores indicate greater spasticity, representing a worse outcome.
|
Week 12 after intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM)
Time Frame: Week 12 after intervention completion.
|
The GMFM is scored on a 0 to 100% scale, reflecting the percentage of motor tasks successfully performed.
Minimum Value (0%): No motor function achieved (worse outcome).
Maximum Value (100%): Full achievement of all motor tasks (better outcome).
Higher scores indicate better gross motor function and improved mobility.
|
Week 12 after intervention completion.
|
|
Time up and go test (TUG)
Time Frame: Week 12 after intervention completion
|
The TUG test measures the time (in seconds) taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
Minimum Value (lower time in seconds): Faster completion time indicates better mobility and functional performance.
Maximum Value (higher time in seconds): Slower completion time indicates impaired mobility and a higher risk of falls (worse outcome).
|
Week 12 after intervention completion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Brain Damage, Chronic
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscle Spasticity
- Cerebral Palsy
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Dry Needling
Other Study ID Numbers
- BMCDryNeedle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.