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CompletedNCT06493344Updated Jul 11, 2024

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

An interventional study of Applying additional weight in Cerebral Palsy, Gait, Spastic and Motor Disorders, sponsored by University of Thessaly. Completed at 1 site in Greece. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by University of Thessaly · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Sep 2021, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
12 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • cerebral palsy
  • crouch gait
  • physiotherapy
  • balance
  • kinematic analysis
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 2 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Spastic Cerebral Palsy Group

    Conventional physiotherapy and training with applying additional weight

    Other: Applying additional weight

Interventions

  • OtherApplying additional weight

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

06

What researchers measure

Primary outcomes

  1. Kinovea

    Kinovea is a 2D video annotation tool designed for kinematic analysis. Assessment of knee angle during stance phase.

    Time frame: up to 16 weeks (every 4 weeks)

  2. 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)

    Time frame: up to 16 weeks (every 4 weeks)

  3. 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)

    Time frame: up to 16 weeks (every 4 weeks)

  4. 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.

    Time frame: up to 16 weeks (every 4 weeks)

07

Study locations

1 site
  • Department of Physiotherapy - University of Thessaly
    Lamía, Phthiotis 35132, Greece
08

References and documents

Publications

  • 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. PubMed 26853808 ↗
  • 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. PubMed 34407619 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06493344
Lead sponsor
University of Thessaly
Responsible party
George Paras (Assistant Professor, University of Thessaly) — Principal investigator
First posted
Jul 10, 2024
Start date
Sep 23, 2021
Primary completion
Mar 23, 2022
Completion
May 23, 2022
Last update
Jul 11, 2024

Study contacts

George Paras, Ph.D.
principal investigator · University of Thessaly

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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