NCT06637579

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

October 10, 2024

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • GMFM 88 (gross motor function measure)

    GMFM is an assessment tool used to evaluate and measure gross motor function in CP

    6 weeks

  • TIS (trunk impairment scale)

    TIS is a clinical assessment tool designed to evaluate trunk control

    6 weeks

  • Pediatric Berg Balance Scale

    The Pediatric Balance Scale is used to assess functional balance skills in school-aged children

    6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: universal exercise unit therapy with task oriented strength training

Group B

EXPERIMENTAL

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

Other: Task-oriented training for gross motor functioning

Interventions

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

Group A

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

Group B

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sialkot Medical and Physiotherapy Center

Sialkot, Punjab Province, 51310, Pakistan

RECRUITING

Study Officials

  • Muhammad Asrar Yousaf, M.phil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

January 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations