The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy

July 9, 2024 updated by: George Paras, University of Thessaly

The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy. Assessment of the Kinematics, Balance and Functional Level

The purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Phthiotis
      • Lamía, Phthiotis, Greece, 35132
        • Department of Physiotherapy - University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The children who participated in the study, aged 12 - 15 years old, were diagnosed with spastic cerebral palsy, level III according to the classification of the GMFCS.

Exclusion Criteria:

From the study, they were excluded:

  1. children who have received botulinum toxin injection up to 3 months before,
  2. children who have had selective rhizotomy surgery up to 1 year before,
  3. children who have a baclofen pump,
  4. children with uncontrolled epilepsy,
  5. children with cognitive deficits who cannot follow verbal instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spastic Cerebral Palsy Group
Conventional physiotherapy and training with applying additional weight
Other: Applying additional weight
Treadmill training with and without weight (15 minutes of 3 times/ per week for 16 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinovea
Time Frame: up to 16 weeks (every 4 weeks)
Kinovea is a 2D video annotation tool designed for kinematic analysis. Assessment of knee angle during stance phase.
up to 16 weeks (every 4 weeks)
Timed Up and Go
Time Frame: up to 16 weeks (every 4 weeks)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in disabled children. Unit of measure: seconds of completion (higher scores - worse outcomes)
up to 16 weeks (every 4 weeks)
Gross Motor Function Measure 88 (GMFM-88)
Time Frame: up to 16 weeks (every 4 weeks)
An assessment tool designed and evaluated to measure changes in gross motor function over time in children with cerebral palsy. Unit of Measure: Scoring Options (0, 1, 2, 3, or "not tested") // (higher scores - better outcome)
up to 16 weeks (every 4 weeks)
Sit to Stand (STS) test of the NeuroCom® Balance Master®
Time Frame: up to 16 weeks (every 4 weeks)
A cutting-edge technology used at Balance and Mobility Therapy to accurately assess and treat balance disorders.
up to 16 weeks (every 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: George Paras, Ph.D., University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Actual)

March 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • add-weight-CP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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