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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Routine Physical therapy with Neurodevelopmental technique; Other: Routine Physical therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • University of Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuro-developmental Physical Therapy+ Routine Physical Therapy; 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; 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; Other: 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
Experimental: Routine Physical therapy: 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; 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; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Chair: Shehzeena Ashraf, University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: cerebral palsy; gross motor function; neurodevelopmental technique; health realted quality of life; routine physical therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: REC-UOL-536-09-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No