NCT06667388

Brief Summary

Children with cerebral palsy frequently experience balance issues and gait impairments; gait training is a crucial component of their rehabilitation because it greatly enhances the children's socialisation and quality of life.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 30, 2024

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pediatric Functional Independent Measure for Children (WeeFIM)

    The Independence Measure for Children (WeeFIM®) is frequently used as a multiple tool in pediatric clinics to assess the self-care, mobility, and psychological well-being of many groups of children, including those with developmental or developmental disabilities. The Functional Independence Measure for Children (WeeFIM) is an 18-item, seven-level ordinal scale instrument used to assess a child's typical and consistent performance.Children 0 to \<3 years no WeeFIM (or FIM) is required. Children 3 to \<12

    12 Months

Study Arms (2)

Group A

EXPERIMENTAL
Diagnostic Test: Group A

Group B

ACTIVE COMPARATOR
Combination Product: Grojup B

Interventions

Group ADIAGNOSTIC_TEST

each participant of this groups will receive 4 weeks of FWT and 4 weeks of BWT (the training order of A group will FWT and BWT), with a washout period of 2 weeks during the post-intervention phase of the 1st period and the pre-intervention phase for the 2nd period.

Group A
Grojup BCOMBINATION_PRODUCT

each participant of B group will receive 4 weeks of BWT and 4 weeks of FWT (the training order of group B will be BWT and FWT, opposite to group A), with a washout period of 2 weeks during the post-intervention phase of the 1st period and the pre-intervention phase for the 2nd period.

Group B

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Only CP patients will be included.
  • Patient will be included from Bahawalpur only.
  • Patient will be included having minimum age of 10 year.

You may not qualify if:

  • Other cities patient will not be included.
  • Patient less than 10 years age.
  • Patient suffering from other neurological conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sadiq abbasi hospital bwp Contact: jangi wala road BWP

Chak Four Hundred Fifty-four, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Chromosomes, Human, 1-3

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Chromosomes, HumanChromosomes, MammalianChromosomesGenetic StructuresGenetic 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

October 30, 2024

First Posted

October 31, 2024

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

November 15, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations