Cerebral Palsy (CP)NCT06856473
Effects of Dry Needling on Spasticity and Functional Ability
A study testing Traditional Physical Therapy and Dry Needling in people with Cerebral Palsy (CP), run by Batterjee Medical College at 1 site in Saudi Arabia.
Trial summary
This study investigates the effects of dry needling on spasticity and its impact on functional ability in individuals with neuromuscular disorders. Using the Modified Ashworth Scale (MAS), Timed Up and Go (TUG) test, and Gross Motor Function Measure (GMFM), the research evaluates changes in muscle tone, mobility, and… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Traditional Physical Therapy and Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Feb 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hypertonia score 2 according to MAS
- Able to understand and follow instructions
- Able to stand and walk independantly
Who cannot join
- Participants with neurological conditions that involve significant cognitive deficits or severe uncontrolled epilepsy
- Participants who have undergone surgical procedures within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling on Spasticity and Functional Ability in Children With Cerebral Palsy
This study investigates the effects of dry needling on spasticity and its impact on functional ability in individuals with neuromuscular disorders. Using the Modified Ashworth Scale (MAS), Timed Up and Go (TUG) test, and Gross Motor Function Measure (GMFM), the research evaluates changes in muscle tone, mobility, and overall motor performance following dry needling intervention. The findings aim to provide evidence on the clinical benefits of dry needling as a therapeutic approach for improving movement efficiency and functional outcomes in patients with spasticity.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Traditional Physical Therapy, Dry Needling
- Keywords
- Dry Needle, Spasticity, Functional abilities
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical TherapyOther
Also called Conventional physical therapy
Traditional Physical Therapy based on neurodevelopmental technique
Dry NeedlingOther
Also called Study group
Dry Needling in addition to the same traditional physical therapy program
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy Group | Active comparator | Traditional physical therapy program based on neurodevelopmental treatment (NDT) (3 sessions per week, each lasting 1 hour). Receives: Other: Traditional Physical Therapy |
| Dry needling Group | Experimental | 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. Receives: Other: Traditional Physical Therapy; Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashwarth Scale (MAS)
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.
Measured: Week 12 after intervention completion
Secondary outcomes (2)
Gross Motor Function Measure (GMFM)
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.
Measured: Week 12 after intervention completion.
Time up and go test (TUG)
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).
Measured: Week 12 after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start20 Feb 2025
- Primary completion30 Jun 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study follows a randomized controlled trial (RCT) design with a parallel-group interventional model to evaluate the effects of dry needling on spasticity and functional outcomes. Participants are randomly assigned to one of two groups: Study Group (Intervention Group): Receives dry needling for the spastic calf and adductor muscles in addition to a traditional physical therapy program based on Neurodevelopmental Treatment (NDT) (3 sessions per week, each lasting 1 hour). Control Group: Receives only the traditional physical therapy program (NDT) without dry needling, following the same frequency and duration.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856473
- Sponsor's protocol ID
- BMCDryNeedle
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alkhamees NH, Abdelraouf OR, Abdel Ghafar MA, Ibrahim ZM, Harraz EM, Seyam MK, Morsy WE, Ahmed MM. Adjunctive dry needling reduces spasticity and improves functional outcomes in children with cerebral palsy: a single-blind randomized controlled trial. Front Pediatr. 2026 Aug 27;14:1865049. doi: 10.3389/fped.2026.1865049. eCollection 2026.
PubMed 42723892
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Spasticity and Functional Ability in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06856473
- Acronym / sponsor ID
- BMCDryNeedle
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Dry Needle, Spasticity, Functional abilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 4 Mar 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.
This study investigates the effects of dry needling on spasticity and its impact on functional ability in individuals with neuromuscular disorders. Using the Modified Ashworth Scale (MAS), Timed Up and Go (TUG) test, and Gross Motor Function Measure (GMFM), the research evaluates changes in muscle tone, mobility, and overall motor performance following dry needling intervention. The findings aim to provide evidence on the clinical benefits of dry needling as a therapeutic approach for improving movement efficiency and functional outcomes in patients with spasticity.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study follows a randomized controlled trial (RCT) design with a parallel-group interventional model to evaluate the effects of dry needling on spasticity and functional outcomes. Participants are randomly assigned to one of two groups: Study Group (Intervention Group): Receives dry needling for the spastic calf and adductor muscles in addition to a traditional physical therapy program based on Neurodevelopmental Treatment (NDT) (3 sessions per week, each lasting 1 hour). Control Group: Receives only the traditional physical therapy program (NDT) without dry needling, following the same frequency and duration.
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy Group | Active comparator | Other: Traditional Physical TherapyTraditional physical therapy program based on neurodevelopmental treatment (NDT) (3 sessions per week, each lasting 1 hour). |
| Dry needling Group | Experimental | Other: Traditional Physical Therapy, Other: Dry Needlingtraditional 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertonia score 2 according to MAS
- Able to understand and follow instructions
- Able to stand and walk independantly
Key exclusion criteria (2 listed)
- Participants with neurological conditions that involve significant cognitive deficits or severe uncontrolled epilepsy
- Participants who have undergone surgical procedures within the last 3 months
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 |
|---|---|---|
| Traditional Physical TherapyAlso: Conventional physical therapyTraditional Physical Therapy based on neurodevelopmental technique | Other | Dry needling Group, Traditional physical therapy Group |
| Dry NeedlingAlso: Study groupDry Needling in addition to the same traditional physical therapy program | Other | Dry needling Group |
Primary outcome
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.
2 secondary outcomes
Gross Motor Function Measure (GMFM)
Time frame: Week 12 after intervention completion.
Time up and go test (TUG)
Time frame: Week 12 after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 42723892Alkhamees NH, Abdelraouf OR, Abdel Ghafar MA, Ibrahim ZM, Harraz EM, Seyam MK, Morsy WE, Ahmed MM. Adjunctive dry needling reduces spasticity and improves functional outcomes in children with cerebral palsy: a single-blind randomized controlled trial. Front Pediatr. 2026 Aug 27;14:1865049. doi: 10.3389/fped.2026.1865049. eCollection 2026.
- Individual participant dataSharing planned: No
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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 Traditional Physical Therapy and Dry Needling in people with Cerebral Palsy (CP), run by Batterjee Medical College at 1 site in Saudi Arabia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Sep 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Ashwarth Scale (MAS) (time frame: Week 12 after intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856473, which also lists 1 linked publication.
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 17 Sep 2025.