NCT05436847

Brief Summary

The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 23, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

: Spastic Quadriplegia, Cerebral palsyProprioceptive training, Somatosensory input

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function

    Gross Motor Function Classification System (GMFCS) is a 5-level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities. Higher scores indicate better improvement in gross motor functions.

    9 months

Study Arms (2)

Group A

EXPERIMENTAL

NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) Proprioceptive Input- age appropriate (Pushups Static quadruped, squat sitting, trampoline, hopping etc. With weights and splints for joint to joint approximation)

Other: Proprioceptive Training

Group B

ACTIVE COMPARATOR

NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate)

Other: Routine Physical Therapy

Interventions

Proprioceptive Training using increased joint to joint approximation through ankle weights and joint splints.

Group A

Neurodevelopmental treatment- age appropriate

Group B

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with the diagnosis of Cerebral Palsy (Spastic quadriplegia)
  • Ages of 1 to 5 years
  • Both males and females
  • Alert and responsive to verbal and non-verbal commands
  • Modified Ashworth Sale grade 1 to 2
  • Gross Motor Function Classification System level 1V and V

You may not qualify if:

  • Children under the botox treatment for tone management (botulinum injections)
  • Diagnosed with any disease other than spastic quadriplegic cerebral palsy i.e. congenital heart defects, epilepsy, recurrent pneumonia, skin infections etc.
  • Children underwent any surgery i.e. tenotomy (tendon release), recent heart surgery,
  • Recent fracture and subluxation/dislocation due to fall or poor handling
  • Any contracture or deformity on upper extremities, lower extremities and spine i.e. flexion contractures, club foot, scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral PalsyQuadriplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Jawad, MSPTN

    University of Lahore

    PRINCIPAL INVESTIGATOR

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

June 23, 2022

First Posted

June 29, 2022

Study Start

December 1, 2021

Primary Completion

May 30, 2022

Study Completion

June 10, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations