NCT06233136

Brief Summary

Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

July 24, 2023

Last Update Submit

January 30, 2024

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Leg Pedalling

Outcome Measures

Primary Outcomes (2)

  • The gross motor function scale

    Assessment of change of functional ability carried out by using gross motor function measures

    2 months for each participant

  • Assessment of trunk control

    Assessment of change of trunk control carried out by using trunk control measurement scale

    2 months for each participant

Study Arms (2)

Leg Pedalling exercise and designed physical therapy program

EXPERIMENTAL

Each child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes; 1. Flexibility exercises 2. Static and dynamic balance exercises 3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month

Device: Leg pedalling exerciseOther: The designed physical therapy program

Designed physical therapy program

ACTIVE COMPARATOR

The designed physical therapy program It will be applied for all participated children in both groups. It includes; 1. Flexibility exercises 2. Static and dynamic balance exercises 3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month

Other: The designed physical therapy program

Interventions

Leg pedalling exerciseDEVICE

Each child in the experimental group will be positioned in inclined position and will cycle through the range of motion under the supervision of the researcher

Also known as: Leg ergometer
Leg Pedalling exercise and designed physical therapy program
The designed physical therapy programOTHER

It applied for all participated children in both groups. It includes; 1. Flexibility exercises 2. Static and dynamic balance 3. Functional training exercises

Also known as: Traditional physical therapy program
Designed physical therapy programLeg Pedalling exercise and designed physical therapy program

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.
  • Level II, III according to Gross MotorFunctional Classification System (GMFCS).
  • Able to pedal independently on a static bicycle.
  • Ability to follow command.

You may not qualify if:

  • Significant visual or auditory impairments.
  • Structural or fixed deformities of lower extremities.
  • Perception disorders.
  • Botox injection in the lower extremity in the past 6 months.
  • Lower extremity surgery within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo University

Dokki, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • NANEES E Mohamed, Phd

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific researcher

Study Record Dates

First Submitted

July 24, 2023

First Posted

January 31, 2024

Study Start

March 13, 2023

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

EG(1)