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Completed

NCT Number: NCT06232330

Effects of TOA Versus PNF Techniques on Trunk Control in Children With Hemiplegic Cerebral Palsy

Cerebral palsy occurs in 2-2.5 per 1000 live births, seems to be the most common cause of lifelong physical disability, and has an impact on the child, caregivers, and society. The incidence of cerebral palsy continues to rise owing to the large numbers of premature and high-risk infants who survive. Task-oriented arm approaches promote intensive, meaningful, and goal-oriented training in subjects, and the voluntary functional activities of these subjects possibly reduce their motor disabilities.

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Key information

Conditions

Hemiplegic Cerebral Palsy Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

The study will be randomized clinical trial used to evaluate the effectiveness of TOA and PNF on trunk control in children with hemiplegic cerebral palsy. Subjects with hemiplegic cerebral palsy meeting the inclusion and exclusion criteria will be divided into two groups using non- probability sampling techniques. Assessment will be done using trunk control measuring scale and pediatric reach test . Group A will receive TOA and conventional therapy and Group B will receive PNF and conventional therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The level of gross motor function between I and III in accordance with the Gross Motor Function Classification System (GMFCS)
  • The degree of spasticity in the affected lower extremity between grade 1 and 1+ in accordance with the Modified Ashworth scale
  • 6-12 years of age
  • Ability to understand and follow verbal instructions

Exclusion criteria

  • Surgical procedures within the past 6 months
  • Botox injection within 6 months
  • Unstable Seizures
  • Other comorbidity condition (Multiple Disabilities)

Treatment and study plan

Group A

Device

This group will receive TOA which include Weight transfers from a standing position and stepping in various star-type directions, Sit-ups from different heights with the hemiplegic lower limb behind the normal lower limb, From a kneeling position alternately projecting the lower limb forward, From a standing position with a limited base of support turning head and trunk right to left, Continuous walking on a treadmill for 10 minutes, Ascending and descending of stairs, Crossing 4 obstacles with continuous walking, Walking while simultaneously pushing a stroller, Walking while holding an object, Walking on different surfaces and slopes, The intervention took place for 5 days a week for 6 week for 20 minutes. Pre measurement was taken before the intervention and after 6 weeks post measurement was taken.

Group B

Device

This group will receive PNF techniques for trunk control. Rhythmic initiation and Rhythmic stabilization for a span of 20 minutes on both sides. In rhythmic initiation patient will move passively from trunk flexion into extension and then back to the flexed position When the patient is relaxed and moving easily, ask for active assisted motion Then begin resisting the motion then patient will perform independently in rhythmic stabilization Resist an isometric contraction of the patient's trunk flexor muscles patient will match the resistance in front and then in back

Primary outcomes

  1. Trunk Control Measuring Scale

    Time frame: 6 weeks

    The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item.

  2. Pediatric Reach Test

    Time frame: 6 weeks

    It is used to measure the standing balance in normally developed or children with cerebral palsy, that's why is done in standing position. The standing position will be described first and target will be set under the supervision first forward reach will be tested and after this lateral reach will be tested. Reliability of this test is within rater (0.54, 0.88 ICC) and among the rater is (0.50, 0.93ICC)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Task Oriented Approach Versus Rhythmic Initiation And Stabilization Techniques of PNF on Trunk Control in Children With Hemiplegic Cerebral Palsy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Jun 13, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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