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

NCT06493344 | Completed

• 1 other identifier: add-weight-CP
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Gait, Spastic; Motor Disorders; Functional Neurological Disorder

Keywords

cerebral palsy; crouch gait; physiotherapy; balance; kinematic analysis

Outcome Measures

Primary Outcomes (4)

• Kinovea

  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)

• Gross Motor Function Measure 88 (GMFM-88)

  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)

• Timed Up and Go

  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)

• Sit to Stand (STS) test of the NeuroCom® Balance Master®

  A cutting-edge technology used at Balance and Mobility Therapy to accurately assess and treat balance disorders.

  up to 16 weeks (every 4 weeks)

Study Arms (1)

Spastic Cerebral Palsy Group

EXPERIMENTAL

Conventional physiotherapy and training with applying additional weight

Other: Applying additional weight

Interventions

Applying additional weight OTHER

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

Spastic Cerebral Palsy Group

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Department of Physiotherapy - University of Thessaly

Lamia, Phthiotis, 35132, Greece

Location

Related Publications (2)

• Verschuren O, Peterson MD, Balemans AC, Hurvitz EA. Exercise and physical activity recommendations for people with cerebral palsy. Dev Med Child Neurol. 2016 Aug;58(8):798-808. doi: 10.1111/dmcn.13053. Epub 2016 Feb 7.

  PMID: 26853808 BACKGROUND

• Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.

  PMID: 34407619 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic; Motor Disorders; Conversion Disorder

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Somatoform Disorders

Study Officials

• George Paras, Ph.D.

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 10, 2024
• Study Start: September 23, 2021
• Primary Completion: March 23, 2022
• Study Completion: May 23, 2022
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)