Effects Of Dry Needling On Mobility Among Children With Cerebral Palsy

NCT06661421 | Completed DMC

• 1 other identifier: REC/RCR&AHS/24/0701
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cerebral Palsy; Spasticity; Dry Needling; Range of Motion; Functional Mobility

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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 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.

Study Arms (2)

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.

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.

Other: Cerebral Palsy conventional Treatment

Interventions

Dry Needling DEVICE

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.

Dry Needling Group

Cerebral Palsy conventional Treatment 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 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.

Conventional Therapy Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 32327366 BACKGROUND

• 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.

  PMID: 30346254 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Maheen Ahmad Khan, MS*

  Riphah International Univerisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols, and possible efforts will be put to mask both groups about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: September 24, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)