Cerebral Palsy (CP)DRYSPARCNCT06661421
Effects Of Dry Needling On Mobility Among Children With Cerebral Palsy
A study testing Dry Needling and Cerebral Palsy conventional Treatment in people with Cerebral Palsy (CP) and Spasticity, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study explores the potential of dry needling as a treatment for spasticity in the foot among children with cerebral palsy (CP). Dry needling involves inserting fine needles into specific trigger points or tight muscles without injecting any substances, aiming to relieve pain, improve muscle function, and promote… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Spasticity, Range of Motion
- What is being tested?
- Dry Needling and Cerebral Palsy conventional Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Sep 2024to 1 Jan 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 to 12 years old
- Walking ability at Gross Motor Function Classification System levels I to II
- Modified Modified Ashworth Scale (MAS) score higher than equal to 1 (score up to 2)
- Ability to understand and execute orders
- No ongoing rehabilitation intervention
Who cannot join
- Recent introduction of a new intervention in addition to previous treatments
- Presence of bleeding disorders or skin conditions
- Skin sensitivity issues
- History of seizures within the past six months
- Previous administration of BTX-A injection within the last 6 months
- Presence of
- contraindications to dry needling
- Lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54700
About this study
Official title: Effects of Dry Needling on Spasticity, Range of Motion, and Functional Mobility Among Children With Cerebral Palsy
This study explores the potential of dry needling as a treatment for spasticity in the foot among children with cerebral palsy (CP). Dry needling involves inserting fine needles into specific trigger points or tight muscles without injecting any substances, aiming to relieve pain, improve muscle function, and promote tissue healing. In CP-related foot spasticity, dry needling may target hypertonic muscles, inducing a local twitch response that helps release muscle tension, reduce spasticity, and enhance overall muscle function. The technique may also stimulate sensory nerves and trigger the release of endorphins, contributing to pain relief and muscle relaxation.
While dry needling has shown effectiveness in reducing spasticity and improving muscle function in adults with conditions such as post-stroke, there is limited research on its benefits for children with CP. This randomized controlled trial aims to address this gap by evaluating the impact of dry needling on spasticity, range of motion, and functional mobility in children with CP.
Read the detailed description
The study will be conducted at Bliss Center of Care and Therapy in Faisalabad, involving 38 participants aged 6 to 12 years, all diagnosed with spastic cerebral palsy and classified under the Gross Motor Function Classification System (GMFCS) levels I-II. Participants will be divided into two groups: an experimental group receiving dry needling therapy (DNT) and routine physical therapy (RPT) and a control group receiving RPT only. Critical exclusion criteria include recent interventions, bleeding disorders, fixed joint deformities, recent seizures, Botulinum Toxin injections, or contraindications to dry needling.
Outcomes will be measured using the Wartenberg Pendulum Test, Active and Passive Ankle Dorsiflexion Range of Motion, and the Timed Up and Go Test, which will be assessed before and after a 10-week intervention. Data will be analyzed using SPSS version 23.0 to determine the efficacy of dry needling in managing spasticity in children with CP.
- Conditions
- Cerebral Palsy (CP), Spasticity, Range of Motion, Functional Mobility
- Being tested
- Dry Needling, Cerebral Palsy conventional Treatment
- Keywords
- Cerebral Palsy, Spasticity, Dry Needling, Range of Motion, Functional Mobility
- 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.
Dry NeedlingDevice
This intervention combines Dry Needling Therapy (DNT) with routine physical therapy for children with spastic cerebral palsy. The experimental group will receive DNT alongside physical therapy, while the control group will undergo only physical therapy. Routine Physical Therapy includes a warm-up, stretching, and strengthening exercises like hamstring stretches and squats, adjusted over a month with increasing intensity. Dry Needling targets the gastrocnemius muscle using a fast-in, fast-out technique with sterile needles, applied weekly for 10 weeks. This combined approach aims to reduce spasticity, improve mobility, and enhance range of motion, distinguishing it from standard therapies.
Cerebral Palsy conventional TreatmentOther
Sessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel rises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three sessions per week, focusing on hamstring stretches and progressive resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | Group A will receive Dry Needling Therapy (DNT) along with routine physical therapy. Each session includes a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, psoas stretching will be done prone, with assisted hip extension for 5 seconds and a 40-second hold, repeated five times. Strengthening exercises, including squats, heel rises, and step-ups with a loaded backpack, will target the lower extremities. The program lasts one month with three sessions per week, gradually increasing in intensity. Dry Needling (DN) uses 0.30 × 50 mm needles, applying the fast-in, fast-out technique for 1 minute per muscle. DN is done once per week for 10 weeks, with at least 48 hours between treatments. Receives: Device: Dry Needling |
| Conventional Therapy Group | Other | Sessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel raises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three weekly sessions focusing on hamstring stretches and progressive resistance exercises. Receives: Other: Cerebral Palsy conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wartenberg Pendulum Test
In the Wartenberg Pendulum Test, the extended leg of a supine individual is allowed to fall freely, and under normal circumstances, it swings back and forth like a pendulum. However, in spastic limbs, the viscoelastic properties and heightened stretch reflexes dampen the swing, limiting its motion. To conduct the test, the individual should be seated with legs hanging freely and their back supported. They must fully relax the muscles, especially in the tested leg, with gentle support under the thigh if needed. The examiner holds the lower leg above the ankle, ensuring the knee is straight but not hyperextended, and then gently moves the leg to the side before releasing it to swing freely. The examiner observes the initial swing amplitude and subsequent swings, noting any decrease and counting swings until rest. The test is repeated on the other leg for comparison. Reduced amplitude or asymmetry suggests spasticity and the relaxation index (R2 ratio) is commonly measured.
Measured: The Wartenberg Pendulum Test will be conducted once upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Wartenberg Pendulum Test will be performed two times.
Secondary outcomes (2)
Ankle Dorsiflexion Range of Motion
Ankle dorsiflexion ROM, active and passive, is assessed with the patient supine and the knee extended, using a manual goniometer. The fulcrum is placed on the lateral malleolus, the stationary arm aligned with the fibula, and the movable arm parallel to the fifth metatarsal. Test-retest reliability of ankle dorsiflexion ROM using a universal goniometer has shown ICC values ranging from 0.75 to 0.96, with a comprehensive score of 0.91, indicating excellent reliability.
Measured: The Ankle dorsiflexion ROM will be conducted once upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Ankle dorsiflexion ROM will be performed two times.
The Ankle dorsiflexion ROM will be conducted upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Ankle dorsiflexion ROM will be performed two times.
The Modified Timed Up and Go (TUG) test evaluates functional ambulatory mobility and dynamic balance in children. It measures the time a child takes to stand seated, walk 3 meters, touch a star on the wall, return to the chair, and sit down. For the procedure, the child starts by sitting on a stool with their feet flat on the floor, knees, and hips at 90° flexion. They are then instructed to stand, walk 3 meters, touch the star on the wall, return to the chair, and sit down. The child may wear regular footwear or orthoses, and walking aids are permitted, but no physical assistance is provided. The timing is recorded with a stopwatch, and there is no time limit; the child may rest if needed without sitting down. The Modified TUG test demonstrates excellent reliability, with an intraclass correlation coefficient (ICC) of 0.99 for both within-session and test-retest assessments, making it a valuable tool for evaluating mobility in pediatric rehabilitation.
Measured: The Modified Timed Up and Go Test will be conducted once at the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Modified Timed Up and Go will be performed two times.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start24 Sep 2024
- Primary completion15 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A sample size of 38 was calculated using Epitool online software, and the mean values of dynamic balance from the previous study were taken. By adding a 10% attrition rate (34+4), the sample size will be 38.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maheen Ahmad Khan, MS*, Principal investigator, Riphah International Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661421
- Sponsor's protocol ID
- REC/RCR&AHS/24/0701
- Acronym
- DRYSPARC
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghannadi S, Shariat A, Ansari NN, Tavakol Z, Honarpishe R, Dommerholt J, Noormohammadpour P, Ingle L. The Effect of Dry Needling on Lower Limb Dysfunction in Poststroke Survivors. J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104814. doi: 10.1016/j.jstrokecerebrovasdis.2020.104814. Epub 2020 Apr 21.
PubMed 32327366Cruz-Montecinos C, Nunez-Cortes R, Bruna-Melo T, Tapia C, Becerra P, Pavez N, Perez-Alenda S. Dry needling technique decreases spasticity and improves general functioning in incomplete spinal cord injury: A case report. J Spinal Cord Med. 2020 May;43(3):414-418. doi: 10.1080/10790268.2018.1533316. Epub 2018 Oct 22.
PubMed 30346254
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Spasticity, Range of Motion, and Functional Mobility Among Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06661421
- Acronym / sponsor ID
- DRYSPARC / REC/RCR&AHS/24/0701
- Conditions
- Cerebral Palsy (CP), Spasticity, Range of Motion, Functional Mobility
- Keywords
- Cerebral Palsy, Spasticity, Dry Needling, Range of Motion, Functional Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 Oct 2024 (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 explores the potential of dry needling as a treatment for spasticity in the foot among children with cerebral palsy (CP). Dry needling involves inserting fine needles into specific trigger points or tight muscles without injecting any substances, aiming to relieve pain, improve muscle function, and promote tissue healing. In CP-related foot spasticity, dry needling may target hypertonic muscles, inducing a local twitch response that helps release muscle tension, reduce spasticity, and enhance overall muscle function. The technique may also stimulate sensory nerves and trigger the release of endorphins, contributing to pain relief and muscle relaxation.
While dry needling has shown effectiveness in reducing spasticity and improving muscle function in adults with conditions such as post-stroke, there is limited research on its benefits for children with CP. This randomized controlled trial aims to address this gap by evaluating the impact of dry needling on spasticity, range of motion, and functional mobility in children with CP.
Detailed description
The study will be conducted at Bliss Center of Care and Therapy in Faisalabad, involving 38 participants aged 6 to 12 years, all diagnosed with spastic cerebral palsy and classified under the Gross Motor Function Classification System (GMFCS) levels I-II. Participants will be divided into two groups: an experimental group receiving dry needling therapy (DNT) and routine physical therapy (RPT) and a control group receiving RPT only. Critical exclusion criteria include recent interventions, bleeding disorders, fixed joint deformities, recent seizures, Botulinum Toxin injections, or contraindications to dry needling.
Outcomes will be measured using the Wartenberg Pendulum Test, Active and Passive Ankle Dorsiflexion Range of Motion, and the Timed Up and Go Test, which will be assessed before and after a 10-week intervention. Data will be analyzed using SPSS version 23.0 to determine the efficacy of dry needling in managing spasticity in children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A sample size of 38 was calculated using Epitool online software, and the mean values of dynamic balance from the previous study were taken. By adding a 10% attrition rate (34+4), the sample size will be 38.
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Device: Dry NeedlingGroup A will receive Dry Needling Therapy (DNT) along with routine physical therapy. Each session includes a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, psoas stretching will be done prone, with assisted hip extension for 5 seconds and a 40-second hold, repeated five times. Strengthening exercises, including squats, heel rises, and step-ups with a loaded backpack, will target the lower extremities. The program lasts one month with three sessions per week, gradually increasing in intensity. Dry Needling (DN) uses 0.30 × 50 mm needles, applying the fast-in, fast-out technique for 1 minute per muscle. DN is done once per week for 10 weeks, with at least 48 hours between treatments. |
| Conventional Therapy Group | Other | Other: Cerebral Palsy conventional TreatmentSessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel raises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three weekly sessions focusing on hamstring stretches and progressive resistance exercises. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 6 to 12 years old
- Walking ability at Gross Motor Function Classification System levels I to II
- Modified Modified Ashworth Scale (MAS) score higher than equal to 1 (score up to 2)
- Ability to understand and execute orders
- No ongoing rehabilitation intervention
Key exclusion criteria (8 listed)
- Recent introduction of a new intervention in addition to previous treatments
- Presence of bleeding disorders or skin conditions
- Skin sensitivity issues
- History of seizures within the past six months
- Previous administration of BTX-A injection within the last 6 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 |
|---|---|---|
| Dry NeedlingThis intervention combines Dry Needling Therapy (DNT) with routine physical therapy for children with spastic cerebral palsy. The experimental group will receive DNT alongside physical therapy, while the control group will undergo only physical therapy. Routine Physical Therapy includes a warm-up, stretching, and strengthening exercises like hamstring stretches and squats, adjusted over a month with increasing intensity. Dry Needling targets the gastrocnemius muscle using a fast-in, fast-out technique with sterile needles, applied weekly for 10 weeks. This combined approach aims to reduce spasticity, improve mobility, and enhance range of motion, distinguishing it from standard therapies. | Device | Dry Needling Group |
| Cerebral Palsy conventional TreatmentSessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel rises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three sessions per week, focusing on hamstring stretches and progressive resistance exercises. | Other | Conventional Therapy Group |
Primary outcome
Wartenberg Pendulum Test
Time frame: The Wartenberg Pendulum Test will be conducted once upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Wartenberg Pendulum Test will be performed two times.
In the Wartenberg Pendulum Test, the extended leg of a supine individual is allowed to fall freely, and under normal circumstances, it swings back and forth like a pendulum. However, in spastic limbs, the viscoelastic properties and heightened stretch reflexes dampen the swing, limiting its motion. To conduct the test, the individual should be seated with legs hanging freely and their back supported. They must fully relax the muscles, especially in the tested leg, with gentle support under the thigh if needed. The examiner holds the lower leg above the ankle, ensuring the knee is straight but not hyperextended, and then gently moves the leg to the side before releasing it to swing freely. The examiner observes the initial swing amplitude and subsequent swings, noting any decrease and counting swings until rest. The test is repeated on the other leg for comparison. Reduced amplitude or asymmetry suggests spasticity and the relaxation index (R2 ratio) is commonly measured.
2 secondary outcomes
Ankle Dorsiflexion Range of Motion
Time frame: The Ankle dorsiflexion ROM will be conducted once upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Ankle dorsiflexion ROM will be performed two times.
The Ankle dorsiflexion ROM will be conducted upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Ankle dorsiflexion ROM will be performed two times.
Time frame: The Modified Timed Up and Go Test will be conducted once at the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Modified Timed Up and Go will be performed two times.
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 13 Jan 2025.
- Background: PubMed 32327366Ghannadi S, Shariat A, Ansari NN, Tavakol Z, Honarpishe R, Dommerholt J, Noormohammadpour P, Ingle L. The Effect of Dry Needling on Lower Limb Dysfunction in Poststroke Survivors. J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104814. doi: 10.1016/j.jstrokecerebrovasdis.2020.104814. Epub 2020 Apr 21.
- Background: PubMed 30346254Cruz-Montecinos C, Nunez-Cortes R, Bruna-Melo T, Tapia C, Becerra P, Pavez N, Perez-Alenda S. Dry needling technique decreases spasticity and improves general functioning in incomplete spinal cord injury: A case report. J Spinal Cord Med. 2020 May;43(3):414-418. doi: 10.1080/10790268.2018.1533316. Epub 2018 Oct 22.
- 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.
Maheen Ahmad Khan, MS* principal investigator
Riphah International Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Cerebral Palsy conventional Treatment in people with Cerebral Palsy (CP) and Spasticity, run by Riphah International 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 5 inclusion and 8 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 13 Jan 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?
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?
Wartenberg Pendulum Test (time frame: The Wartenberg Pendulum Test will be conducted once upon the start of the trial (Pre-test) and once at the end of trial (Post-Test) to check the effect of the research. In total, the Wartenberg Pendulum Test will be performed two times.). 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 NCT06661421, which also lists 2 linked publications.
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 13 Jan 2025.