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

NCT ID: NCT06637579

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-11-30

Brief Summary

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.

Conditions

Cerebral Palsy Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A received universal exercise unit therapy with task-oriented strength training.

Group Type: EXPERIMENTAL

universal exercise unit therapy with task oriented strength training

Intervention Type: OTHER

Leg press, Sit to stand, Half knee rise, Lateral step up, Forward step up.

Group B

Group B received task-oriented training for gross motor functioning.

Group Type: EXPERIMENTAL

Task-oriented training for gross motor functioning

Intervention Type: OTHER

Standing transfer (hip abduction/adduction), Stair climbing (hip extension, calf raise), Walking and gait training, Reaching and grasping activities.

Interventions

universal exercise unit therapy with task oriented strength training

Leg press, Sit to stand, Half knee rise, Lateral step up, Forward step up.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Asrar Yousaf, M.phil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Sialkot Medical and Physiotherapy Center

Sialkot, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, PHD

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Facility Contacts

Fasih Ahmed Rehmani, MS-OMPT

Role: primary

Fasih12190@gmail.com

03348005240

Other Identifiers

REC/RCR&AHS/24/0210

Identifier Type: -

Identifier Source: org_study_id