Effects of Routine Physical Therapy With and Without Neurodevelopmental Technique on GMF, Spasticity and HRQOL in Diplegic CP

Cerebral Palsy Clinical Trial

Official title:

Effects Of Routine Physical Therapy With And Without Neuro-Developmental Technique On Gross Motor Function, Spasticity And Health Related Quality Of Life In Diplegic Cerebral Palsy- A Randomized Controlled Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06444230
• Other study ID #: REC-UOL-536-09-2023
• Status: Completed
• Phase: N/A
• Start date: July 27, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2024
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy.

Description:

The neurological illness known as cerebral palsy is caused by damage to the growing brain and therefore is indicated by anomalies of muscle strength, mobility, and motor functions. Cerebral palsy affects posture, muscle tone, and movement development. Neurodevelopmental technique and routine physical therapy are considered to be effective in treatment of cerebral palsy. This study will investigate the combined effects of neurodevelopmental technique and routine physical therapy versus routine physical therapy on gross motor function, spasticity, and health related quality of life in diplegic cerebral palsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients with an age of 8 to 18 years of both genderswith confirm diagnosis of diplegic cerebral palsy

• Patients could ambulate functionally

• Patients having limited or no prior exposure to NDT

• Individuals with mild to moderate diplegic cerebral palsy, based on established classification scales (GMFM grade I-III)

Exclusion Criteria:

• Patients with other motor or sensory dysfunctions and unable to understand and obey commands

• Patient undergone any orthopedic surgery that was ought to treatspasticity

• Patients with spasticity level 4-5 according to Modified Ashworth Scale

• Patients with Botulinum toxins type A injection within last 6 months

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Routine Physical therapy with Neurodevelopmental technique
participants will recieve a session of 40 minutes including routine physical therapy along with the neurodevelopmental technique for 3 times a week for 12 weeks
• Routine Physical therapy
participants will recieve a session of 40 minutes including, stretching, neck and trunk stabilization and strengthening exercise followed by a warm up and cool down for 3 times a week for 12 weeks follo

Locations

Country	Name	City	State
Pakistan	University of Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale	UMN syndrome's component of spasticity is an increase in muscular stretch out reflexes that is velocity-dependent and accompanied by an increase in muscle tone. Bryan Ashworth developed the Ashworth Scale in 1964 while treating patients with MS as a way to grade spasticity. The original Ashworth scale, which rated spasticity on a scale of 0 to 4, classified it as either having no resistance or having limbs that were stiff in flexion or extension. They added 1+ to the scale to boost sensitivity(Bohannon & Smith, 1987). Muscle spasticity is rated using the modified Ashworth scale score ranging from 0 to 4, having total 6 grades	9 months
Primary	Gross Motor Function Measure	Each item is rated on a four-point ordinal system of assessment. A score of 0 means the task cannot be performed, a score of 1 means the task is able to be started (10% completion), a score of 2 means the task may be completed partially (10% to 100% completion), and a score of 3 means the task is capable of being finished.Every unobserved item on the GMFM-88 receives a score of 0. On the contrast, GMFM-66, however, items that were not seen received a "not tested" or "missing" score.Both versions of GMFM has an excellent reliability	9 months
Primary	Cerebral Palsy Quality of Life Questionnaire for Children and Adolescent	The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the very first quality of life survey founded on the International Classification of Function (ICF) created particularly for kids with CP.The CP QOL-Child is available in two versions: the main caregiver-proxy report version (proxy version) for kids ages 4 to 12 and a self-report version for kids ages 9 to 12. The CP QOL-Child's internal consistency, test-retest reliability, and construct validity have all been proven to be reliable and valid.	9 months
Secondary	Manual Muscle Testing	The most popular technique for identifying muscle strength deficits is MMT. According to the dimensions of the muscle and the power of the examiner, scores range from zero contractions to a contraction which can be done against gravity and can withstand the examiner's "maximal" resistance. The examiner rates the muscular groups under study as either "weak" or "strong" on a scale of zero to five while applying force against the participant's resistance	9 months