Clinical trial NCT06661421: Effects Of Dry Needling On Mobility Among Children With Cerebral Palsy
Official title: Effects of Dry Needling on Spasticity, Range of Motion, and Functional Mobility Among Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Spasticity
Range of Motion
Functional Mobility
Keywords: Cerebral Palsy
Spasticity
Dry Needling
Range of Motion
Functional Mobility
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Wartenberg Pendulum Test
timeFrame: 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:
measure: Ankle Dorsiflexion Range of Motion
timeFrame: 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.
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International Univerisity
name: Maheen Ahmad Khan, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cruz-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.