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Recruiting NCT06637579

Effects of Universal Exercise Unit Therapy With Task-oriented Training in CP Children

No phase Interventional Cerebral Palsy Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: universal exercise unit therapy with task oriented strength training, Task-oriented training for gross motor functioning.
Who it may be relevant to
Registry conditions: Cerebral Palsy Children. Basic parameters: 5 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Universal Exercise Unit Therapy With Task-oriented Training on Lower Extremity Gross Motor Function and Balance in Cerebral Palsy Children

Overview

Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage. Muscle rigidity, spasticity, fragility, uncontrolled movement, or a combination of these abnormalities characterized it. Therapeutic usage of the universal exercise unit is common. Also called a spider cage or monkey cage. This device helps people with motor problems, especially cerebral palsy. This metal 3-dimensional contraption uses wires, rubber bands, pulleys, weights, and belts. The goal is to engage the vestibular and proprioceptive systems, which are necessary for balance, coordination, and awareness.

Detailed description

A Randomized Clinical Trial (RCT) design will be employed, conducted at the Sialkot Medical and Physiotherapy Center over 10 months following synopsis approval. The anticipated sample size, accounting for a 20% attrition rate, will be 34 participants in each of the two study groups. Group A will undergo Universal Exercise Unit (UEU) therapy along with task oriented training, while Group B will receive task-oriented training for gross motor functioning. The sampling technique will be Non-probability convenience sampling, with inclusion criteria comprising children aged 5-15 diagnosed with spastic cerebral palsy, of both genders and in stable health condition. The data collection tools include the Gross Motor Function Measure 88 (GMFM 88), Trunk Impairment Scale (TIS) and pediatric balance scale. The analysis will be conducted using SPSS for Windows software version 25. Training sessions, lasting 6 weeks, will be conducted twice a week, and data will be collected before and after each session. The UEU therapy will focus on various movements facilitated by the equipment, while the task-oriented training will be personalized, targeting specific functional limitations through activities simulating daily tasks.

Interventions

  • Other universal exercise unit therapy with task oriented strength training
    Leg press, Sit to stand, Half knee rise, Lateral step up, Forward step up.
  • Other Task-oriented training for gross motor functioning
    Standing transfer (hip abduction/adduction), Stair climbing (hip extension, calf raise), Walking and gait training, Reaching and grasping activities.

Primary outcome measures

  • GMFM 88 (gross motor function measure) [Time frame: 6 weeks]
  • TIS (trunk impairment scale) [Time frame: 6 weeks]
  • Pediatric Berg Balance Scale [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • Children who were spastic and able to understand and follow commands. Children aged 5-15 years old. Gross Motor Function Classification System (GMFCS) level I-III. Youngsters are capable of walking and standing on their own.

Exclusion criteria

  • Children with severe physical limitations and disabilities. Children with planned surgeries in the next 6 months. Any musculoskeletal or orthopedic conditions limiting participation in exercise programs.

Kids with planned surgical or medical surgeries during the study period. Children with impaired cognition. Children with hearing impairment and visual impairment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Sialkot Medical and Physiotherapy Center — Sialkot

Identifiers

NCT: NCT06637579 · REC/RCR&AHS/24/0210

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗