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

NCT06444230 | Completed DMC

• 1 other identifier: REC-UOL-536-09-2023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; gross motor function; neurodevelopmental technique; health realted quality of life; routine physical therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Manual Muscle Testing

  9 months

Study Arms (2)

Neuro-developmental Physical Therapy+ Routine Physical Therapy

EXPERIMENTAL

* Protocol of 40 minutes focusing on gross motor functional movements including upright sitting at the table, walking, kneeling, running and stair climbing. * Used a Neuro-developmental method to inhibit undesirable movement patterns and facilitate favorable movement patterns. * Weight-bearing exercises that involved proprioceptive training while in various positions (such as quadruped, kneeling, half kneeling, and standing). * Facilitating weight transfer forward, backward, and sideways during balancing reactions from various balance board postures

Other: Routine Physical therapy with Neurodevelopmental technique; Other: Routine Physical therapy

Routine Physical therapy:

EXPERIMENTAL

All children in this group received physical therapy of 40 minutes, 3 times per week for 12weeks, which included passive stretching with focus on diplegic limb 8 minutes, neck and trunk postural control for 8 minutes, strength training 8 minutes, ambulation and gait training for 8 minutes with 2 minutes rest interval between each set of exercise.

Other: Routine Physical therapy with Neurodevelopmental technique; Other: Routine Physical therapy

Interventions

Routine Physical therapy with Neurodevelopmental technique OTHER

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

Neuro-developmental Physical Therapy+ Routine Physical Therapy; Routine Physical therapy:

Routine Physical therapy OTHER

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

Neuro-developmental Physical Therapy+ Routine Physical Therapy; Routine Physical therapy:

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shehzeena Ashraf

  University of Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 5, 2024
• Study Start: July 27, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)