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)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ziauddin University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diplegic Spastic Cerebral Palsy

Interventions

Type	Name	Description
OTHER	Instrument Assisted Soft Tissue Mobilization	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	Neurodevelopmental Therapy	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.

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-11-25
• Last updated: 2024-11-25

Locations

1 site across 1 country: Pakistan