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Completed

NCT Number: NCT06493344

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Conversion Disorder Functional Neurological Disorder Gait Disorders, Neurologic Gait, Spastic Mental Disorders Motor Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy - University of Thessaly

Lamia, Phthiotis, 35132, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Treatment and study plan

Applying additional weight

Other

Treadmill training with and without weight (15 minutes of 3 times/ per week for 16 weeks).

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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