NCT06232330

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

CPHemiplegiaRhythmic InitiationRhythmic StabilizationTOA

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

TOA and conventional therapy

Device: Group A

Group B

EXPERIMENTAL

PNF and conventional therapy

Device: Group B

Interventions

Group ADEVICE

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 A
Group BDEVICE

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

Group B

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • years of age
  • Ability to understand and follow verbal instructions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

    PMID: 36415346BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayesha Ijaz, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be randomized clinical trial used to evaluate the effect of task-oriented training on balance in spastic hemiplegic cerebral palsied children. Subjects with hemiplegic Cerebral Palsy meeting the inclusion and exclusion criteria will be divided into two groups using non-probability sampling techniques.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 30, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations