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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06232330
Other study ID # REC/RCR&AHS/23/0738
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date February 5, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Group A
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
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

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk Control Measuring Scale 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. 6 weeks
Primary Pediatric Reach Test 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) 6 weeks
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