Effects Of Dry Needling On Mobility Among Children With Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy (CP); Spasticity; Range of Motion; Functional Mobility

• Registration Number: NCT06661421
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2024-09-24
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Status Verified: 2024-12
• Primary Completion: 2024-12-15
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wartenberg Pendulum Test	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.

Secondary Outcome Measures

Name	Time	Method
Ankle Dorsiflexion Range of Motion	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.	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.
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 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.	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.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Lahore, Punjab, Pakistan