NCT06851117

Brief Summary

This study will evaluate the comparative effectiveness of Spider Cage Therapy (SCT) and Proprioceptive Neuromuscular Facilitation (PNF) in managing motor impairments in children with cerebral palsy (CP). Cerebral palsy often leads to motor deficits that limit movement and impair functionality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

October 28, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 24, 2025

Last Update Submit

February 24, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Gross Motor Function Measure (GMFM-66

    Five levels and each has different nbr of questions each having 0- 3 score 0 no movement 3 complete movement

    12 Months

  • Paedetric balance scale

    14 items each have 0-4 score total 56 0 totally dependent 4 independently can prrform movement

    12 months

  • Functional Independence Measure for Children (WeeFIM)

    for overall functional independence (FIM) it has total 18 items 13 relatesd to mobilty and 5 regarding cognition Each has1- 7 score where reports total dependence and 7 shows complete independence

    12 months

Study Arms (3)

Proprioceptive Neuromuscular Facilitation (PNF)

EXPERIMENTAL
Combination Product: Proprioceptive Neuromuscular Facilitation (PNF)

Spider Cage Therapy Group

EXPERIMENTAL
Combination Product: Spider Cage Therapy Group

Combined PNF and Spider Cage Therapy Group

ACTIVE COMPARATOR
Diagnostic Test: Combined PNF and Spider Cage Therapy Group

Interventions

Participants in the PNF group will undergo intensive training of the affected limbs for 20 minutes per day, 5 days a week, over a 4-week period. During therapy sessions, the unaffected limb will be constrained using a mitt or cast to encourage focused activation and strengthening of the affected side. The therapy will include repetitive movement patterns designed to enhance strength, flexibility, and coordination.

Proprioceptive Neuromuscular Facilitation (PNF)
Spider Cage Therapy GroupCOMBINATION_PRODUCT

This group will participate in therapy sessions within the Spider Cage for 20 minutes per day, 5 days a week, for 4 weeks. Interventions will involve weight-bearing exercises, movement facilitation, and balance training, utilizing the cage's elastic cords to support and stabilize posture. The goal is to improve gross motor skills, balance, and controlled movement.

Spider Cage Therapy Group

Participants in this group will receive both PNF and Spider Cage Therapy, with integrated principles and techniques from both approaches. The intensity and duration will be consistent with the individual therapy groups, with sessions held for 20 minutes per day, 5 days a week, over 4 weeks. This combination is expected to enhance functional outcomes by targeting both strength/coordination and balance/postural control.

Combined PNF and Spider Cage Therapy Group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-12 years.
  • Clinical diagnosis of cerebral palsy.
  • Classified within Gross Motor Function Classification System (GMFCS) levels I to III.
  • Ability to follow instructions and participate in therapy sessions.

You may not qualify if:

  • Severe cognitive impairments hindering participation.
  • Severe musculoskeletal deformities or recent surgeries.
  • Other medical conditions contraindicating participation in physical therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 28, 2025

Study Start

October 28, 2023

Primary Completion

April 20, 2024

Study Completion

August 28, 2024

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations