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NCT Number: NCT06702709

Comparing the Instrument-Assisted Soft Tissue Mobilization and Neurodevelopmental Therapy for Gross Motor Functions, Muscle Tone and Spasticity in Children with Spastic Diplegic Cerebral Palsy (GMFCS Levels I and II)

Cerebral palsy is a neurological condition that affects individuals worldwide, with a global burden of 0.9%. However, prevalence rates show regional variation, with high-income countries reporting rates of 0.2% and low-income countries of 0.3%. In Pakistan, cerebral palsy is the third most common (10.5%) neurological condition in the child population, with a significantly higher frequency of 1.22 per 1000 live births. Amongst the various subtypes of cerebral palsy, spastic diplegic cerebral palsy and spastic quadriplegic cerebral palsy are the most prevalent, accounting for 39% of cases, followed by athetoid (3.34%) and ataxic (10.1%) cerebral palsy in Pakistan.

Individuals with spastic diplegic cerebral palsy exhibit distinct characteristics, including increased muscle tone, scissoring of the lower extremities, and functional impairment. Scissors in the lower limbs, a common manifestation in spastic diplegic cerebral palsy, often result from of hamstring and gastrocnemius hypertonia. The modified Ashworth scale is a sensitive and reliable tool commonly used to assess hypertonicity. This condition primarily results from spasticity caused by upper motor neuron lesions, resulting in excessive alpha motor neuron activity that increases the stretch reflex and muscle tone. Fortunately, spastic diplegic cerebral palsy can be managed with various pharmacological and non-pharmacological approaches.

Pharmacological management includes the use of oral baclofen and botulinum toxin injections. Surgical interventions such as intrathecal baclofen and muscle lengthening procedures are also used to reduce spasticity. However, physical therapy plays a vital role in the management of spastic diplegic cerebral palsy and is critical to improving outcomes for affected individuals. Various physical therapy approaches have been used effectively, including neurodevelopmental therapies, strengthening, passive stretching, strength training combined with stretching, restriction-induced movement therapy and targeted motor reduction programs. Despite their effectiveness, these methods have inherent limitations, such as the limited range of motion with the balance ball, the long time required for motion limitation therapy, and the discomfort associated with stretching exercises. Additionally, differences in practices between therapists were observed.

To address these limitations and improve therapeutic outcomes, the concept of "Instrument Assisted Soft Tissue Mobilization (IASTM)" was introduced. IASTM is a skilled technique involving the use of specialized tools to manipulate the skin, myofascia, muscles, and tendons using direct compression stroke techniques. The application of IASTM tools helps release soft tissue with myofascial adhesions, leading to pain relief, improved range of motion, and improved function. In the context of cerebral palsy, the IASTM is a promising approach, affecting two-point discrimination, pressure pain threshold, and local temperature. In addition, IASTM can promote connective tissue remodeling by breaking down scar tissue, adhesions, and fascial restrictions. In addition, it has been shown to reduce muscle tone by stimulating mechanoreceptors that activate inhibitory interneurons in the spinal cord, leading to decreased activity of alpha motor neurons in extrafusal fibers.

Despite evidence supporting the beneficial impact of IASTM on the special needs population, there is still a paucity of literature on the use of IASTM tools and their effects, particularly for individuals with cerebral palsy. To the best of our knowledge, the use of IASTM is a novel therapeutic approach in the cerebral palsy population of Pakistan to manage muscle tone, range of motion of knee extension and ankle dorsiflexion, and gross motor function. Therefore, this study aims to explore the potential benefits of IASTM in this specific population and aims to provide valuable insights for future research and therapeutic interventions.

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Key information

Conditions

Diplegic Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral palsy, spastic, diplegic Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziauddin College of Physical Therapy

Karachi, Sindh, 74500, Pakistan

About this study

A total of 60 participants were recruited for this study after obtaining informed, voluntary assent from the guardians of the participants. Each participant was randomly allocated to group A (n=30), which received Instrument Assisted Soft Tissue Mobilization (IASTM), or group B (n=30), which received neurodevelopmental therapy (NDT). Moreover, the envelope method of simple random sampling was used for group allocation, ensuring that the participants remained blind to their group assignment.

Each participant underwent a baseline assessment before starting the intervention, which lasted 4 weeks. After the 4-week intervention period, the interventions were stopped while standard physical therapy continued, and participants were assessed to measure the immediate effects of both IASTM and neurodevelopmental therapy. Subsequently, a follow-up assessment was carried out at week 8 to evaluate any residual effects of the interventions.

During the study, three participants from the IASTM group and eight participants from the NDT group dropped out, resulting in final groups of 27 participants in group A and 22 participants in group B, respectively. The outcome measures included the Modified Ashworth Scale for hypertonicity assessment, the Universal Goniometer for range of motion (ROM) of knee extension and ankle dorsiflexion, and dimensions D and E of GMFM-88 for evaluating gross motor skills.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with diagnosed Diplagic cerebral palsy are referred by a physician
  • Age 4-12 years.
  • Children with mild to moderate spasticity according to the Modified Ashworth scale (grade 1, 1+).
  • Children with GMFCS level-I and II will be included.
  • Children with pseudomyostatic contractures

Exclusion criteria

  • Localized infectious disease.
  • Inflammatory skin condition.
  • Diagnosed soft tissue injury of hamstring/gastrocnemius.
  • Open wound.
  • Osteomyelitis
  • Children with a history of any lower limb surgical intervention.
  • Sensory impairments especially in lower extremities.
  • History of botulinum toxin injections within 4 months before study entry .

Treatment and study plan

Instrument assisted soft tissue mobilization

Other

The IASTM method will be applied bilaterally to each target muscle, duration 25 minutes. During treatment, three repetitions are performed on each target muscle, with each repetition lasting 50 seconds. The IASTM technique will be applied at a 60-degree angle. The application sequence follows a specific pattern: For the first 10 seconds, light pressure will be applied during the sweeping stroke, and for the next 20 seconds, moderate pressure will apply during the fanning and brushing strokes. Finally, 10 seconds of deep pressure will administer utilizing oblique sweeping strokes. To help the tissues relax, the treatment will finish with mild sweeping and broad strokes on the hamstring region for 10 seconds

Other names: IASTM

Neurodevelopmental therapy

Other

The neurodevelopment therapy for spastic diplegic cerebral palsy includes tone-inhibitory postures. This study will use five-tone inhibitory postures that will be appropriate for the reduction of muscle tone, elongation of lower extremities muscles, and improve gross motor function by enhancing balance and stability. The following posture will be repeated 3 times on the bilateral lower limb in one session and maintained for 50 seconds with 60 seconds rest between each posture. The total duration of NDT will be 25 minutes.

Other names: NDT

Primary outcomes

  1. Modified Ashworth scale

    Time frame: Baseline

    The Modified Ashworth Scale is a clinical tool developed to assess muscle tone in people with neurological conditions such as cerebral palsy, spinal cord injury, or stroke.The scale rates muscle tone from 0 to 4, with 0 denoting no increase in muscle tone and 4 denoting affected part is rigid in flexion or extension. In this study the modified ashworth scale give the quantitative evaluation of hamstring and gastrocnemius muscle.

  2. Modified Ashworth scale

    Time frame: 4 Week

    The Modified Ashworth Scale is a clinical tool developed to assess muscle tone in people with neurological conditions such as cerebral palsy, spinal cord injury, or stroke.The scale rates muscle tone from 0 to 4, with 0 denoting no increase in muscle tone and 4 denoting affected part is rigid in flexion or extension. In this study the modified ashworth scale give the quantitative evaluation of hamstring and gastrocnemius muscle.

  3. Modified Ashworth scale

    Time frame: 8 Week

    The Modified Ashworth Scale is a clinical tool developed to assess muscle tone in people with neurological conditions such as cerebral palsy, spinal cord injury, or stroke.The scale rates muscle tone from 0 to 4, with 0 denoting no increase in muscle tone and 4 denoting affected part is rigid in flexion or extension. In this study the modified ashworth scale give the quantitative evaluation of hamstring and gastrocnemius muscle.

  4. Universal Goniometer

    Time frame: Baseline

    A universal goniometer is a gadget that is used to precisely measure joint angles and range of motion. Typically, it has two moveable arms, such as rulers, that can be adjusted to accommodate various body regions and angles. This study evaluate the range of motion of Knee extension and ankle dorsiflexion.

  5. Universal Goniometer

    Time frame: 4 Week

    A universal goniometer is a gadget that is used to precisely measure joint angles and range of motion. Typically, it has two moveable arms, such as rulers, that can be adjusted to accommodate various body regions and angles. This study evaluate the range of motion of Knee extension and ankle dorsiflexion.

  6. Universal Goniometer

    Time frame: 8 Week

    A universal goniometer is a gadget that is used to precisely measure joint angles and range of motion. Typically, it has two moveable arms, such as rulers, that can be adjusted to accommodate various body regions and angles. This study evaluate the range of motion of Knee extension and ankle dorsiflexion.

  7. Gross Motor Function Measure-88

    Time frame: Baseline

    Gross Motor Function Measure-88 (GMFM-88), a widely accepted clinical assessment tool, has been developed to evaluate and assess gross motor function in children with cerebral palsy. GMFM-88 evaluate a child's ability to perform a variety of gross motor skills, such as lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. It consists of 88 items that are categorized into five dimensions. In this study the author will be going to use walking, running, and jumping that is dimension E.

  8. Gross Motor Function Measure-88

    Time frame: 4 Week

    Gross Motor Function Measure-88 (GMFM-88), a widely accepted clinical assessment tool, has been developed to evaluate and assess gross motor function in children with cerebral palsy. GMFM-88 evaluate a child's ability to perform a variety of gross motor skills, such as lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. It consists of 88 items that are categorized into five dimensions. In this study the author will be going to use walking, running, and jumping that is dimension E.

  9. Gross Motor Function Measure-88

    Time frame: 8 Week

    Gross Motor Function Measure-88 (GMFM-88), a widely accepted clinical assessment tool, has been developed to evaluate and assess gross motor function in children with cerebral palsy. GMFM-88 evaluate a child's ability to perform a variety of gross motor skills, such as lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. It consists of 88 items that are categorized into five dimensions. In this study the author will be going to use walking, running, and jumping that is dimension E.

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

EFFECTS of INSTRUMENT-ASSISTED SOFT TISSUE MOBILIZATION VS. NEURODEVELOPMENTAL THERAPY on MOTOR FUNCTION in CHILDREN with GMFCS LEVEL I and II SPASTIC DIPLEGIC CEREBRAL PALSY

Acronym: IASTM;NDT;CP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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